Obstetrics

“FAREWELL TO INDIGO CARMINE”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2014)

Use baby formula to check for bladder integrity
There is an additional method that can be used to check for bladder injury that some of us “older” gynecologists have employed. Baby formula is packaged in sterile bottles. I have had the rare occasion to need to check for bladder integrity and have had the circulating nurse inject diluted formula through the indwelling urinary catheter. I have yet to encounter (or read about) an allergic response from this technique.
Martin E. Kanoff, DO
Sewell, New Jersey

I found Dr. Barbieri’s editorial on the indigo carmine shortage very appropriate and timely.

When intraoperatively testing a bladder repair or looking for a possible bladder injury, administration of phenazopyridine or instillation of dilute methylene blue as noted are reasonable approaches. Due to tissue staining, which can make repeat bladder assessment more difficult, I have found that instilling sterile formula, usually easily available on the obstetric unit, will allow detection of “leaks” and easily can be rinsed out of the pelvis with saline, allowing repeat instillation if necessary.

Also, if the bladder is distended with fluid when looking for defects, it pays to wait a few minutes before decompressing, as small leaks may gradually deflate the bladder and alert the surgeon to the need for further investigation.
William J. Mann, Jr, MD
Executive Medical Director
Olde Towne Medical and Dental Center
Clinical Professor, ObGyn
Virginia Commonwealth School of Medicine
Richmond, Virginia

What about using sterile milk?
Dr. Barbieri, what is your opinion and do you have any ideas on sourcing sterile milk for use in diagnostic cystoscopy and tubal patency in gynecology?
Donna G. Ivery, MD  
Titusville, Florida

Is there a methylene blue shortage too?
I commonly perform chromotubation for my infertility patients and for tubal reversals. I have been substituting methylene blue for indigo carmine. Recently, I was told by my surgical center that methylene blue is on back order. Have you noticed the methylene blue shortage? Do you have suggestions for a replacement for my indications of chromotubation and tubal reversal surgeries?

Online I have seen mention of isosulfan blue being injected into lymphatic tissue to identify sentinel nodes—although it is more expensive. I will be searching now for a supplier of isosulfan blue. Sterile milk has been used to identify bladder fistulas. Can it be used for chromotubation?
Peter G. Van Deerlin, MD
South Jersey Fertility Center
Marlton, New Jersey

Can we brainstorm a solution to the shortage?
Dr. Barbieri, once again you have demonstrated your clear thinking and reasoned approach to what is a clinical problem.

I would add the following thought: Perhaps a group of physicians from major specialty/subspecialty organizations could meet with the present manufacturers and brainstorm for a solution. Self-interest is clearly the practical path and patient safety/customer satisfaction can come into play also.
Stephen S. Schuster, MD
Queens, New York

Another way to diagnose PROM
I read with interest the editorial covering the shortage of indigo carmine. In the section “Options to diagnose PROM … ”, you stated NONE as the option for diagnosing premature rupture of membranes (PROM) when standard clinical testing is equivocal.

A recent article in Journal of Perinatal Medicine suggests that placental alpha microglobulin-1 (PAMG-1) testing is as reliable as dye studies.¹ This was a 140-patient prospective study and is certainly encouraging.

I don’t use PAMG-1 as a first-line agent for diagnosing rupture of membranes (ROM). Speculum examination with pooling of amniotic fluid, nitrozine testing, and microscopic examination for ferning confirm or rule out ROM in most cases. This article points toward avoiding the more invasive dye study. The data are timely in light of the indigo carmine shortage.
John R. Hannig, MD
Salem, Oregon

Reference

Dr. Barbieri responds
I appreciate the great suggestion by Drs. Kanoff, Mann, and Ivery to use sterile baby formula to test bladder integrity. Sterile baby formula is usually available on an obstetric unit, and less available in a main operating room environment. One small caveat about the use of the word “sterile.” Baby formula is “sterile” using criteria for a commercial food product. Injectable agents typically need to be both sterile, using criteria for a pharmaceutical agent, and pyrogen free. These criteria are more stringent than for a food product. Some surgical nursing and pharmacy administrators may focus on this technical difference and resist the use of sterile baby formula to test bladder integrity.

First it was indigo carmine, now methylene blue is on back order. As Dr. Van Deerlin suspects, isosulfan blue is expensive. A 5-mL vial of isosulfan blue has a list price of $714. If no dye were available to test tubal patency, I would consider using saline or lactated Ringer’s solution. I would hesitate to use sterile baby formula because I would be concerned about peritoneal and tubal epithelial inflammation.

Dr. Schuster has a great suggestion to better coordinate the capabilities of manufacturers with the needs of clinicians and patients. We will forward your suggestion to the ACOG leadership.

I agree with Dr. Hannig’s suggestion that measurement of placental alpha macroglobulin-1 in vaginal fluid is an excellent option for replacing intra-amniotic injection of indigo carmine. Some obstetric units have not yet deployed this test because, in many centers, only a few cases per year needed this test. With the loss of access to indigo carmine, it is a good option to consider measurement of placental alpha macroglobulin-1 in vaginal fluid in cases where it is unclear if the membranes have ruptured.

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES”
TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

May I share the video?
The video on patient positioning to prevent postoperative neuropathies is a great resource for physicians and nurses! May I share this video with our gynecologic operative room staff as a teaching tool?
Christinne D. Canela, MD
Roanoke, Virginia

The Editors respond
This, and all of the videos at obgmanagement.com are meant to be shared with your colleagues. 

“TISSUE EXTRACTION DURING MINIMALLY INVASIVE GYN SURGERY. SECOND OF 2 PARTS: COUNSELING THE PATIENT”
(ROUNDTABLE; OCTOBER 2014)

May I morcellate your uterus please?
The laparoscopic approach to the fibroid uterus is currently a puzzle. After the FDA released a statement in April postulating that the use of power morcellation to remove uterine fibroids should be “discouraged,” a great controversy developed in the minimally invasive surgical community.

Subsequently in July, the Obstetrics and Gynecology Devices Advisory Panel of the FDA held a 2-day meeting to analyze risks, benefits, and the overall clinical role of laparoscopic power morcellation in gynecology. One recommendation was to include in the informed consent a disclosure of the risks of disseminating an occult uterine malignancy. I salute the efforts of the panel and agree on the necessity for a comprehensive consent process that discloses risks that could worsen the patient’s prognosis.

Soon after that FDA panel met in July, Ethicon, a division of Johnson and Johnson, made a business decision to initiate a worldwide withdrawal of the company’s morcellation devices.

Now, on November 24, the FDA issued an updated Safety Communication recommending that the use of power morcellators is contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal. They also said that laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. The FDA is issuing a boxed warning, and recommends that surgeons thoroughly discuss the benefits and risks of all treatment to patients, including younger women who want to maintain their fertility or women not yet perimenopausal who wish to keep their uterus.

How will having a patient sign a consent form change the risk of unfortunate dispersion? How will it protect the surgeon from the subsequent liability? Who will be responsible for worsening the patient’s survival?

Month after month in the Medical Verdicts column, we see cases of unfortunate patients who suffer well-known surgical complications that are litigated, with different outcomes and compensations. I am certain that in most of these cases, the patients had signed at least a standard consent form that lists the most commonly known complications. Having a patient sign a consent form does not reduce the incidence of complications nor protect the physician from liability.

In my opinion, effort should be concentrated on finding a way to better preoperatively identify the patient at risk of occult uterine malignancy so that the surgical approach can be modified accordingly.

The controversy regarding morcellation is far from over. Perhaps the last tissue extractor remaining in the market should be used to morcellate the tort system and finally build a system that will protect patients and physicians.
Jose Carugno, MD
Miami, Florida

Dr. Iglesia responds
Dr. Carugno is correct. A “consent form” does not protect the surgeon from potential liability nor the patient from potential harm. Informed decision-making is a process wherein providers and patients discuss the diagnoses and conditions; the treatment options and alternatives ranging from expectant management, medical management or surgical intervention; and the potential risks and benefits of each of those options. Physicians should perform an adequate preoperative evaluation, and patients should be given the opportunity to ask questions with the understanding that no treatment is without risks (including the option for watchful waiting). Physicians should describe the steps that will be taken during the preoperative, intraoperative, and postoperative periods to mitigate those risks.

“TOTAL ABDOMINAL HYSTERECTOMY THE MAYO CLINIC WAY” JOHN B. GEBHART, MD, MS (SURGICAL TECHNIQUE; OCTOBER 2014)

We need to focus on improving vaginal hysterectomy
I found Dr. Gebhart’s article on abdominal hysterectomy technically very accurate and well written. It is with the greatest respect that I write to express my concern with the author’s response that because of the restriction of power morcellation devices, the rate of abdominal hysterectomy will increase.

Rather than focus on the improvement of the most common gynecologic surgical procedure, we should be focusing on improving techniques of vaginal hysterectomy, a route that unfortunately is under-taught in the United States.

I have been a practicing ObGyn for more than 20 years, and exclusively as a gynecologist for the last 4 years. I perform vaginal hysterectomies more than 90% of the time. My total abdominal hysterectomy and laparoscopic-assisted vaginal hysterectomy rates remain less than 5%; laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy rates: 0%; and power morcellation rate: 0%. 

In conclusion, why abdominal hysterectomy?
Robert C. Raymond, MD, MBA
Fort Payne, Alabama

Dr. Gebhart responds
Dr. Raymond, I thank you for your comments and question. I applaud your surgical skill set and approach to hysterectomy. My preferred route of hysterectomy for benign disease is the vaginal route. A few years ago we published an article in OBG Management on keys to success in vaginal hysterectomy.¹ Indeed, the vaginal approach remains the least expensive and least morbid approach to hysterectomy, yet the least common. I continue to publish and lecture on the benefits of a vaginal approach and societies, such as the Society of Gynecologic Surgeons (SGS), remain committed to teaching and advocating this well-established, evidence-based yet underutilized approach.

Given the interest and controversy in the use of power morcellation after the FDA’s Safety Communication last April,² it was felt that a good technical review of abdominal hysterectomy was cogent. If surgeons have a concern about using power morcellation or their institution has banned use of a power morcellator, then the abdominal route is the most likely alternative for removing the enlarged uterus intact. As you state, the abdominal approach remains the most common route of hysterectomy. My sense is that most providers faced with an enlarged uterus that cannot be removed via laparoscopic morcellation (for reasons stated previously) are likely to turn to abdominal hysterectomy. Hopefully, the article gives readers a chance to assess and develop their technical approach to abdominal hysterectomy.

References

Share your thoughts on these letters or on another article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“FAREWELL TO INDIGO CARMINE”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2014)

Use baby formula to check for bladder integrity
There is an additional method that can be used to check for bladder injury that some of us “older” gynecologists have employed. Baby formula is packaged in sterile bottles. I have had the rare occasion to need to check for bladder integrity and have had the circulating nurse inject diluted formula through the indwelling urinary catheter. I have yet to encounter (or read about) an allergic response from this technique.
Martin E. Kanoff, DO
Sewell, New Jersey

I found Dr. Barbieri’s editorial on the indigo carmine shortage very appropriate and timely.

When intraoperatively testing a bladder repair or looking for a possible bladder injury, administration of phenazopyridine or instillation of dilute methylene blue as noted are reasonable approaches. Due to tissue staining, which can make repeat bladder assessment more difficult, I have found that instilling sterile formula, usually easily available on the obstetric unit, will allow detection of “leaks” and easily can be rinsed out of the pelvis with saline, allowing repeat instillation if necessary.

Also, if the bladder is distended with fluid when looking for defects, it pays to wait a few minutes before decompressing, as small leaks may gradually deflate the bladder and alert the surgeon to the need for further investigation.
William J. Mann, Jr, MD
Executive Medical Director
Olde Towne Medical and Dental Center
Clinical Professor, ObGyn
Virginia Commonwealth School of Medicine
Richmond, Virginia

What about using sterile milk?
Dr. Barbieri, what is your opinion and do you have any ideas on sourcing sterile milk for use in diagnostic cystoscopy and tubal patency in gynecology?
Donna G. Ivery, MD  
Titusville, Florida

Is there a methylene blue shortage too?
I commonly perform chromotubation for my infertility patients and for tubal reversals. I have been substituting methylene blue for indigo carmine. Recently, I was told by my surgical center that methylene blue is on back order. Have you noticed the methylene blue shortage? Do you have suggestions for a replacement for my indications of chromotubation and tubal reversal surgeries?

Online I have seen mention of isosulfan blue being injected into lymphatic tissue to identify sentinel nodes—although it is more expensive. I will be searching now for a supplier of isosulfan blue. Sterile milk has been used to identify bladder fistulas. Can it be used for chromotubation?
Peter G. Van Deerlin, MD
South Jersey Fertility Center
Marlton, New Jersey

Can we brainstorm a solution to the shortage?
Dr. Barbieri, once again you have demonstrated your clear thinking and reasoned approach to what is a clinical problem.

I would add the following thought: Perhaps a group of physicians from major specialty/subspecialty organizations could meet with the present manufacturers and brainstorm for a solution. Self-interest is clearly the practical path and patient safety/customer satisfaction can come into play also.
Stephen S. Schuster, MD
Queens, New York

Another way to diagnose PROM
I read with interest the editorial covering the shortage of indigo carmine. In the section “Options to diagnose PROM … ”, you stated NONE as the option for diagnosing premature rupture of membranes (PROM) when standard clinical testing is equivocal.

A recent article in Journal of Perinatal Medicine suggests that placental alpha microglobulin-1 (PAMG-1) testing is as reliable as dye studies.¹ This was a 140-patient prospective study and is certainly encouraging.

I don’t use PAMG-1 as a first-line agent for diagnosing rupture of membranes (ROM). Speculum examination with pooling of amniotic fluid, nitrozine testing, and microscopic examination for ferning confirm or rule out ROM in most cases. This article points toward avoiding the more invasive dye study. The data are timely in light of the indigo carmine shortage.
John R. Hannig, MD
Salem, Oregon

Reference

Dr. Barbieri responds
I appreciate the great suggestion by Drs. Kanoff, Mann, and Ivery to use sterile baby formula to test bladder integrity. Sterile baby formula is usually available on an obstetric unit, and less available in a main operating room environment. One small caveat about the use of the word “sterile.” Baby formula is “sterile” using criteria for a commercial food product. Injectable agents typically need to be both sterile, using criteria for a pharmaceutical agent, and pyrogen free. These criteria are more stringent than for a food product. Some surgical nursing and pharmacy administrators may focus on this technical difference and resist the use of sterile baby formula to test bladder integrity.

First it was indigo carmine, now methylene blue is on back order. As Dr. Van Deerlin suspects, isosulfan blue is expensive. A 5-mL vial of isosulfan blue has a list price of $714. If no dye were available to test tubal patency, I would consider using saline or lactated Ringer’s solution. I would hesitate to use sterile baby formula because I would be concerned about peritoneal and tubal epithelial inflammation.

Dr. Schuster has a great suggestion to better coordinate the capabilities of manufacturers with the needs of clinicians and patients. We will forward your suggestion to the ACOG leadership.

I agree with Dr. Hannig’s suggestion that measurement of placental alpha macroglobulin-1 in vaginal fluid is an excellent option for replacing intra-amniotic injection of indigo carmine. Some obstetric units have not yet deployed this test because, in many centers, only a few cases per year needed this test. With the loss of access to indigo carmine, it is a good option to consider measurement of placental alpha macroglobulin-1 in vaginal fluid in cases where it is unclear if the membranes have ruptured.

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES”
TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

May I share the video?
The video on patient positioning to prevent postoperative neuropathies is a great resource for physicians and nurses! May I share this video with our gynecologic operative room staff as a teaching tool?
Christinne D. Canela, MD
Roanoke, Virginia

The Editors respond
This, and all of the videos at obgmanagement.com are meant to be shared with your colleagues. 

“TISSUE EXTRACTION DURING MINIMALLY INVASIVE GYN SURGERY. SECOND OF 2 PARTS: COUNSELING THE PATIENT”
(ROUNDTABLE; OCTOBER 2014)

May I morcellate your uterus please?
The laparoscopic approach to the fibroid uterus is currently a puzzle. After the FDA released a statement in April postulating that the use of power morcellation to remove uterine fibroids should be “discouraged,” a great controversy developed in the minimally invasive surgical community.

Subsequently in July, the Obstetrics and Gynecology Devices Advisory Panel of the FDA held a 2-day meeting to analyze risks, benefits, and the overall clinical role of laparoscopic power morcellation in gynecology. One recommendation was to include in the informed consent a disclosure of the risks of disseminating an occult uterine malignancy. I salute the efforts of the panel and agree on the necessity for a comprehensive consent process that discloses risks that could worsen the patient’s prognosis.

Soon after that FDA panel met in July, Ethicon, a division of Johnson and Johnson, made a business decision to initiate a worldwide withdrawal of the company’s morcellation devices.

Now, on November 24, the FDA issued an updated Safety Communication recommending that the use of power morcellators is contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal. They also said that laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. The FDA is issuing a boxed warning, and recommends that surgeons thoroughly discuss the benefits and risks of all treatment to patients, including younger women who want to maintain their fertility or women not yet perimenopausal who wish to keep their uterus.

How will having a patient sign a consent form change the risk of unfortunate dispersion? How will it protect the surgeon from the subsequent liability? Who will be responsible for worsening the patient’s survival?

Month after month in the Medical Verdicts column, we see cases of unfortunate patients who suffer well-known surgical complications that are litigated, with different outcomes and compensations. I am certain that in most of these cases, the patients had signed at least a standard consent form that lists the most commonly known complications. Having a patient sign a consent form does not reduce the incidence of complications nor protect the physician from liability.

In my opinion, effort should be concentrated on finding a way to better preoperatively identify the patient at risk of occult uterine malignancy so that the surgical approach can be modified accordingly.

The controversy regarding morcellation is far from over. Perhaps the last tissue extractor remaining in the market should be used to morcellate the tort system and finally build a system that will protect patients and physicians.
Jose Carugno, MD
Miami, Florida

Dr. Iglesia responds
Dr. Carugno is correct. A “consent form” does not protect the surgeon from potential liability nor the patient from potential harm. Informed decision-making is a process wherein providers and patients discuss the diagnoses and conditions; the treatment options and alternatives ranging from expectant management, medical management or surgical intervention; and the potential risks and benefits of each of those options. Physicians should perform an adequate preoperative evaluation, and patients should be given the opportunity to ask questions with the understanding that no treatment is without risks (including the option for watchful waiting). Physicians should describe the steps that will be taken during the preoperative, intraoperative, and postoperative periods to mitigate those risks.

“TOTAL ABDOMINAL HYSTERECTOMY THE MAYO CLINIC WAY” JOHN B. GEBHART, MD, MS (SURGICAL TECHNIQUE; OCTOBER 2014)

We need to focus on improving vaginal hysterectomy
I found Dr. Gebhart’s article on abdominal hysterectomy technically very accurate and well written. It is with the greatest respect that I write to express my concern with the author’s response that because of the restriction of power morcellation devices, the rate of abdominal hysterectomy will increase.

Rather than focus on the improvement of the most common gynecologic surgical procedure, we should be focusing on improving techniques of vaginal hysterectomy, a route that unfortunately is under-taught in the United States.

I have been a practicing ObGyn for more than 20 years, and exclusively as a gynecologist for the last 4 years. I perform vaginal hysterectomies more than 90% of the time. My total abdominal hysterectomy and laparoscopic-assisted vaginal hysterectomy rates remain less than 5%; laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy rates: 0%; and power morcellation rate: 0%. 

In conclusion, why abdominal hysterectomy?
Robert C. Raymond, MD, MBA
Fort Payne, Alabama

Dr. Gebhart responds
Dr. Raymond, I thank you for your comments and question. I applaud your surgical skill set and approach to hysterectomy. My preferred route of hysterectomy for benign disease is the vaginal route. A few years ago we published an article in OBG Management on keys to success in vaginal hysterectomy.¹ Indeed, the vaginal approach remains the least expensive and least morbid approach to hysterectomy, yet the least common. I continue to publish and lecture on the benefits of a vaginal approach and societies, such as the Society of Gynecologic Surgeons (SGS), remain committed to teaching and advocating this well-established, evidence-based yet underutilized approach.

Given the interest and controversy in the use of power morcellation after the FDA’s Safety Communication last April,² it was felt that a good technical review of abdominal hysterectomy was cogent. If surgeons have a concern about using power morcellation or their institution has banned use of a power morcellator, then the abdominal route is the most likely alternative for removing the enlarged uterus intact. As you state, the abdominal approach remains the most common route of hysterectomy. My sense is that most providers faced with an enlarged uterus that cannot be removed via laparoscopic morcellation (for reasons stated previously) are likely to turn to abdominal hysterectomy. Hopefully, the article gives readers a chance to assess and develop their technical approach to abdominal hysterectomy.

References

Share your thoughts on these letters or on another article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“FAREWELL TO INDIGO CARMINE”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2014)

Use baby formula to check for bladder integrity
There is an additional method that can be used to check for bladder injury that some of us “older” gynecologists have employed. Baby formula is packaged in sterile bottles. I have had the rare occasion to need to check for bladder integrity and have had the circulating nurse inject diluted formula through the indwelling urinary catheter. I have yet to encounter (or read about) an allergic response from this technique.
Martin E. Kanoff, DO
Sewell, New Jersey

I found Dr. Barbieri’s editorial on the indigo carmine shortage very appropriate and timely.

When intraoperatively testing a bladder repair or looking for a possible bladder injury, administration of phenazopyridine or instillation of dilute methylene blue as noted are reasonable approaches. Due to tissue staining, which can make repeat bladder assessment more difficult, I have found that instilling sterile formula, usually easily available on the obstetric unit, will allow detection of “leaks” and easily can be rinsed out of the pelvis with saline, allowing repeat instillation if necessary.

Also, if the bladder is distended with fluid when looking for defects, it pays to wait a few minutes before decompressing, as small leaks may gradually deflate the bladder and alert the surgeon to the need for further investigation.
William J. Mann, Jr, MD
Executive Medical Director
Olde Towne Medical and Dental Center
Clinical Professor, ObGyn
Virginia Commonwealth School of Medicine
Richmond, Virginia

What about using sterile milk?
Dr. Barbieri, what is your opinion and do you have any ideas on sourcing sterile milk for use in diagnostic cystoscopy and tubal patency in gynecology?
Donna G. Ivery, MD  
Titusville, Florida

Is there a methylene blue shortage too?
I commonly perform chromotubation for my infertility patients and for tubal reversals. I have been substituting methylene blue for indigo carmine. Recently, I was told by my surgical center that methylene blue is on back order. Have you noticed the methylene blue shortage? Do you have suggestions for a replacement for my indications of chromotubation and tubal reversal surgeries?

Online I have seen mention of isosulfan blue being injected into lymphatic tissue to identify sentinel nodes—although it is more expensive. I will be searching now for a supplier of isosulfan blue. Sterile milk has been used to identify bladder fistulas. Can it be used for chromotubation?
Peter G. Van Deerlin, MD
South Jersey Fertility Center
Marlton, New Jersey

Can we brainstorm a solution to the shortage?
Dr. Barbieri, once again you have demonstrated your clear thinking and reasoned approach to what is a clinical problem.

I would add the following thought: Perhaps a group of physicians from major specialty/subspecialty organizations could meet with the present manufacturers and brainstorm for a solution. Self-interest is clearly the practical path and patient safety/customer satisfaction can come into play also.
Stephen S. Schuster, MD
Queens, New York

Another way to diagnose PROM
I read with interest the editorial covering the shortage of indigo carmine. In the section “Options to diagnose PROM … ”, you stated NONE as the option for diagnosing premature rupture of membranes (PROM) when standard clinical testing is equivocal.

A recent article in Journal of Perinatal Medicine suggests that placental alpha microglobulin-1 (PAMG-1) testing is as reliable as dye studies.¹ This was a 140-patient prospective study and is certainly encouraging.

I don’t use PAMG-1 as a first-line agent for diagnosing rupture of membranes (ROM). Speculum examination with pooling of amniotic fluid, nitrozine testing, and microscopic examination for ferning confirm or rule out ROM in most cases. This article points toward avoiding the more invasive dye study. The data are timely in light of the indigo carmine shortage.
John R. Hannig, MD
Salem, Oregon

Reference

Dr. Barbieri responds
I appreciate the great suggestion by Drs. Kanoff, Mann, and Ivery to use sterile baby formula to test bladder integrity. Sterile baby formula is usually available on an obstetric unit, and less available in a main operating room environment. One small caveat about the use of the word “sterile.” Baby formula is “sterile” using criteria for a commercial food product. Injectable agents typically need to be both sterile, using criteria for a pharmaceutical agent, and pyrogen free. These criteria are more stringent than for a food product. Some surgical nursing and pharmacy administrators may focus on this technical difference and resist the use of sterile baby formula to test bladder integrity.

First it was indigo carmine, now methylene blue is on back order. As Dr. Van Deerlin suspects, isosulfan blue is expensive. A 5-mL vial of isosulfan blue has a list price of $714. If no dye were available to test tubal patency, I would consider using saline or lactated Ringer’s solution. I would hesitate to use sterile baby formula because I would be concerned about peritoneal and tubal epithelial inflammation.

Dr. Schuster has a great suggestion to better coordinate the capabilities of manufacturers with the needs of clinicians and patients. We will forward your suggestion to the ACOG leadership.

I agree with Dr. Hannig’s suggestion that measurement of placental alpha macroglobulin-1 in vaginal fluid is an excellent option for replacing intra-amniotic injection of indigo carmine. Some obstetric units have not yet deployed this test because, in many centers, only a few cases per year needed this test. With the loss of access to indigo carmine, it is a good option to consider measurement of placental alpha macroglobulin-1 in vaginal fluid in cases where it is unclear if the membranes have ruptured.

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES”
TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

May I share the video?
The video on patient positioning to prevent postoperative neuropathies is a great resource for physicians and nurses! May I share this video with our gynecologic operative room staff as a teaching tool?
Christinne D. Canela, MD
Roanoke, Virginia

The Editors respond
This, and all of the videos at obgmanagement.com are meant to be shared with your colleagues. 

“TISSUE EXTRACTION DURING MINIMALLY INVASIVE GYN SURGERY. SECOND OF 2 PARTS: COUNSELING THE PATIENT”
(ROUNDTABLE; OCTOBER 2014)

May I morcellate your uterus please?
The laparoscopic approach to the fibroid uterus is currently a puzzle. After the FDA released a statement in April postulating that the use of power morcellation to remove uterine fibroids should be “discouraged,” a great controversy developed in the minimally invasive surgical community.

Subsequently in July, the Obstetrics and Gynecology Devices Advisory Panel of the FDA held a 2-day meeting to analyze risks, benefits, and the overall clinical role of laparoscopic power morcellation in gynecology. One recommendation was to include in the informed consent a disclosure of the risks of disseminating an occult uterine malignancy. I salute the efforts of the panel and agree on the necessity for a comprehensive consent process that discloses risks that could worsen the patient’s prognosis.

Soon after that FDA panel met in July, Ethicon, a division of Johnson and Johnson, made a business decision to initiate a worldwide withdrawal of the company’s morcellation devices.

Now, on November 24, the FDA issued an updated Safety Communication recommending that the use of power morcellators is contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal. They also said that laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. The FDA is issuing a boxed warning, and recommends that surgeons thoroughly discuss the benefits and risks of all treatment to patients, including younger women who want to maintain their fertility or women not yet perimenopausal who wish to keep their uterus.

How will having a patient sign a consent form change the risk of unfortunate dispersion? How will it protect the surgeon from the subsequent liability? Who will be responsible for worsening the patient’s survival?

Month after month in the Medical Verdicts column, we see cases of unfortunate patients who suffer well-known surgical complications that are litigated, with different outcomes and compensations. I am certain that in most of these cases, the patients had signed at least a standard consent form that lists the most commonly known complications. Having a patient sign a consent form does not reduce the incidence of complications nor protect the physician from liability.

In my opinion, effort should be concentrated on finding a way to better preoperatively identify the patient at risk of occult uterine malignancy so that the surgical approach can be modified accordingly.

The controversy regarding morcellation is far from over. Perhaps the last tissue extractor remaining in the market should be used to morcellate the tort system and finally build a system that will protect patients and physicians.
Jose Carugno, MD
Miami, Florida

Dr. Iglesia responds
Dr. Carugno is correct. A “consent form” does not protect the surgeon from potential liability nor the patient from potential harm. Informed decision-making is a process wherein providers and patients discuss the diagnoses and conditions; the treatment options and alternatives ranging from expectant management, medical management or surgical intervention; and the potential risks and benefits of each of those options. Physicians should perform an adequate preoperative evaluation, and patients should be given the opportunity to ask questions with the understanding that no treatment is without risks (including the option for watchful waiting). Physicians should describe the steps that will be taken during the preoperative, intraoperative, and postoperative periods to mitigate those risks.

“TOTAL ABDOMINAL HYSTERECTOMY THE MAYO CLINIC WAY” JOHN B. GEBHART, MD, MS (SURGICAL TECHNIQUE; OCTOBER 2014)

We need to focus on improving vaginal hysterectomy
I found Dr. Gebhart’s article on abdominal hysterectomy technically very accurate and well written. It is with the greatest respect that I write to express my concern with the author’s response that because of the restriction of power morcellation devices, the rate of abdominal hysterectomy will increase.

Rather than focus on the improvement of the most common gynecologic surgical procedure, we should be focusing on improving techniques of vaginal hysterectomy, a route that unfortunately is under-taught in the United States.

I have been a practicing ObGyn for more than 20 years, and exclusively as a gynecologist for the last 4 years. I perform vaginal hysterectomies more than 90% of the time. My total abdominal hysterectomy and laparoscopic-assisted vaginal hysterectomy rates remain less than 5%; laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy rates: 0%; and power morcellation rate: 0%. 

In conclusion, why abdominal hysterectomy?
Robert C. Raymond, MD, MBA
Fort Payne, Alabama

Dr. Gebhart responds
Dr. Raymond, I thank you for your comments and question. I applaud your surgical skill set and approach to hysterectomy. My preferred route of hysterectomy for benign disease is the vaginal route. A few years ago we published an article in OBG Management on keys to success in vaginal hysterectomy.¹ Indeed, the vaginal approach remains the least expensive and least morbid approach to hysterectomy, yet the least common. I continue to publish and lecture on the benefits of a vaginal approach and societies, such as the Society of Gynecologic Surgeons (SGS), remain committed to teaching and advocating this well-established, evidence-based yet underutilized approach.

Given the interest and controversy in the use of power morcellation after the FDA’s Safety Communication last April,² it was felt that a good technical review of abdominal hysterectomy was cogent. If surgeons have a concern about using power morcellation or their institution has banned use of a power morcellator, then the abdominal route is the most likely alternative for removing the enlarged uterus intact. As you state, the abdominal approach remains the most common route of hysterectomy. My sense is that most providers faced with an enlarged uterus that cannot be removed via laparoscopic morcellation (for reasons stated previously) are likely to turn to abdominal hysterectomy. Hopefully, the article gives readers a chance to assess and develop their technical approach to abdominal hysterectomy.

References

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Women with lupus and a history of preeclampsia have almost fourfold higher odds of subsequent heart disease as measured by coronary artery calcium than do women with the disease who never had preeclampsia, according to findings from an exploratory study.

Women with systemic lupus erythematosus (SLE) are at an increased risk of pregnancy complications, including preeclampsia, preterm birth, and low birth weight, wrote Dr. Pin Lin of the division of rheumatology at Northwestern University, Chicago, and her colleagues (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000024]).

Using data from the longitudinal Study of Long-Term Vascular and Bone Outcomes in Lupus Erythematosus (SOLVABLE), the authors assessed the potential association between these adverse events and subsequent heart disease.

Of the 129 women included in the current study, there were 331 pregnancies, 66% of which occurred before the diagnosis of SLE.

Of the 56 women who reported an adverse event during pregnancy, 26 had at least one pregnancy complicated by preeclampsia, 36 had at least one pregnancy resulting in preterm birth, and 28 had at least one low-birth-weight infant. The women with or without complications had similar ages (44-45 years), SLE characteristics, and circulating markers of inflammation and endothelial activation. They also were similar with respect to many cardiovascular disease risk factors, except that hypertension occurred significantly more often among those with a history of complications (66% vs. 47%).

Results showed that women with a history of preeclampsia were more likely to have a coronary artery calcium (CAC) score greater than or equal to 10 (adjusted odds ratio, 3.7; 95% confidence interval, 1.2-11.9) than were women without a history of preeclampsia after adjustment for age and disease duration. However, the presence of plaque was not associated with this adverse pregnancy outcome, the authors reported.

Low birth weight and preterm birth were not associated with CAC or plaque.

In an accompanying editorial, Dr. Julia F. Simard of Stanford (Calif.) University and Dr. Jinoos Yazdany of the University of California, San Francisco, said that despite a clear question and the clinical significance, the study design and data only hint at an answer (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000035]).

The work should be viewed as exploratory, they said, building a scientific foundation for more definitive studies that will answer questions like:

• Should pregnancy complications alert clinicians caring for women with SLE about subsequent CVD risks necessitating more aggressive risk factor modification?

• Should preeclampsia be viewed as a ‘failed cardiac stress test?’ and

• Does the presence of SLE and preeclampsia together substantially increase CVD risk greater than expected with either risk factor alone?

“As the body of evidence between CVD and pregnancy morbidity grows, this line of study may unlock key risk factors to aid in the identification and management of early CVD in women with SLE,” they concluded.

The study was supported by grants from the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations Inc. No relevant financial disclosures were declared.

Women with lupus and a history of preeclampsia have almost fourfold higher odds of subsequent heart disease as measured by coronary artery calcium than do women with the disease who never had preeclampsia, according to findings from an exploratory study.

Women with systemic lupus erythematosus (SLE) are at an increased risk of pregnancy complications, including preeclampsia, preterm birth, and low birth weight, wrote Dr. Pin Lin of the division of rheumatology at Northwestern University, Chicago, and her colleagues (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000024]).

Using data from the longitudinal Study of Long-Term Vascular and Bone Outcomes in Lupus Erythematosus (SOLVABLE), the authors assessed the potential association between these adverse events and subsequent heart disease.

Of the 129 women included in the current study, there were 331 pregnancies, 66% of which occurred before the diagnosis of SLE.

Of the 56 women who reported an adverse event during pregnancy, 26 had at least one pregnancy complicated by preeclampsia, 36 had at least one pregnancy resulting in preterm birth, and 28 had at least one low-birth-weight infant. The women with or without complications had similar ages (44-45 years), SLE characteristics, and circulating markers of inflammation and endothelial activation. They also were similar with respect to many cardiovascular disease risk factors, except that hypertension occurred significantly more often among those with a history of complications (66% vs. 47%).

Results showed that women with a history of preeclampsia were more likely to have a coronary artery calcium (CAC) score greater than or equal to 10 (adjusted odds ratio, 3.7; 95% confidence interval, 1.2-11.9) than were women without a history of preeclampsia after adjustment for age and disease duration. However, the presence of plaque was not associated with this adverse pregnancy outcome, the authors reported.

Low birth weight and preterm birth were not associated with CAC or plaque.

In an accompanying editorial, Dr. Julia F. Simard of Stanford (Calif.) University and Dr. Jinoos Yazdany of the University of California, San Francisco, said that despite a clear question and the clinical significance, the study design and data only hint at an answer (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000035]).

The work should be viewed as exploratory, they said, building a scientific foundation for more definitive studies that will answer questions like:

• Should pregnancy complications alert clinicians caring for women with SLE about subsequent CVD risks necessitating more aggressive risk factor modification?

• Should preeclampsia be viewed as a ‘failed cardiac stress test?’ and

• Does the presence of SLE and preeclampsia together substantially increase CVD risk greater than expected with either risk factor alone?

“As the body of evidence between CVD and pregnancy morbidity grows, this line of study may unlock key risk factors to aid in the identification and management of early CVD in women with SLE,” they concluded.

The study was supported by grants from the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations Inc. No relevant financial disclosures were declared.

Women with lupus and a history of preeclampsia have almost fourfold higher odds of subsequent heart disease as measured by coronary artery calcium than do women with the disease who never had preeclampsia, according to findings from an exploratory study.

Women with systemic lupus erythematosus (SLE) are at an increased risk of pregnancy complications, including preeclampsia, preterm birth, and low birth weight, wrote Dr. Pin Lin of the division of rheumatology at Northwestern University, Chicago, and her colleagues (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000024]).

Using data from the longitudinal Study of Long-Term Vascular and Bone Outcomes in Lupus Erythematosus (SOLVABLE), the authors assessed the potential association between these adverse events and subsequent heart disease.

Of the 129 women included in the current study, there were 331 pregnancies, 66% of which occurred before the diagnosis of SLE.

Of the 56 women who reported an adverse event during pregnancy, 26 had at least one pregnancy complicated by preeclampsia, 36 had at least one pregnancy resulting in preterm birth, and 28 had at least one low-birth-weight infant. The women with or without complications had similar ages (44-45 years), SLE characteristics, and circulating markers of inflammation and endothelial activation. They also were similar with respect to many cardiovascular disease risk factors, except that hypertension occurred significantly more often among those with a history of complications (66% vs. 47%).

Results showed that women with a history of preeclampsia were more likely to have a coronary artery calcium (CAC) score greater than or equal to 10 (adjusted odds ratio, 3.7; 95% confidence interval, 1.2-11.9) than were women without a history of preeclampsia after adjustment for age and disease duration. However, the presence of plaque was not associated with this adverse pregnancy outcome, the authors reported.

Low birth weight and preterm birth were not associated with CAC or plaque.

In an accompanying editorial, Dr. Julia F. Simard of Stanford (Calif.) University and Dr. Jinoos Yazdany of the University of California, San Francisco, said that despite a clear question and the clinical significance, the study design and data only hint at an answer (Lupus Sci. Med. 2014 Dec. 12 [doi:10.1136/lupus-2014-000035]).

The work should be viewed as exploratory, they said, building a scientific foundation for more definitive studies that will answer questions like:

• Should pregnancy complications alert clinicians caring for women with SLE about subsequent CVD risks necessitating more aggressive risk factor modification?

• Should preeclampsia be viewed as a ‘failed cardiac stress test?’ and

• Does the presence of SLE and preeclampsia together substantially increase CVD risk greater than expected with either risk factor alone?

“As the body of evidence between CVD and pregnancy morbidity grows, this line of study may unlock key risk factors to aid in the identification and management of early CVD in women with SLE,” they concluded.

The study was supported by grants from the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations Inc. No relevant financial disclosures were declared.

Early elective deliveries – inductions and cesarean deliveries before 39 weeks’ gestation – account for nearly 9% of the singleton births paid for under the Medicaid program, according to an analysis published in the December issue of Health Affairs.*

The rate of early elective deliveries has improved over the last few years, falling by nearly a third among Medicaid-financed births between 2007 and 2011 (Health Aff. 2014;33:2170-8).

©Fuse/Thinkstockphotos.com

Medicaid medical directors in Ohio and Minnesota, working with staff members of AcademyHealth, compared birth certificate data and hospital records from 22 states to determine the rate of early elective deliveries from 2010-2012. Twelve states also provided trend data or 2007-2011.

Of the more than 800,000 singleton births paid for by the Medicaid program across the 22 states, about 32% were elective deliveries and nearly 9% were early-term elective deliveries.

Elective cesarean deliveries were more common than were elective labor inductions before 39 weeks’ gestation. And early elective deliveries increased with maternal age. Mothers older than 34 years had the highest rate at 12.7%. Mothers younger than 20 years had the lowest rate at 6.6%. Early elective deliveries were also higher among women with a history of cesarean delivery.

Over the last few years, there has been a steady push to reduce nonmedically indicated early deliveries. Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine say that early elective deliveries are not appropriate.

The federal government is also getting involved. In 2012, the Centers for Medicare & Medicaid Services joined other federal health agencies to launch the Strong Start for Mothers and Newborns Initiative, aimed at reducing early elective deliveries. And decreasing the rate of early elective deliveries is a priority measure in the CMS initial Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid.

More than 20 state Medicaid programs have also implemented policies that discourage early elective deliveries, ranging from clinical education to partnering with hospitals on “hard stop” policies that bar scheduling of deliveries before 39 weeks without documentation of medical necessity.

While the rate of early elective deliveries has been falling since 2007, the researchers could not pinpoint which strategy is most effective, since most of the efforts are new.

*Correction, 1/30/2015: An earlier version of this story misstated the definition of early elective deliveries.

[email protected]

On Twitter @maryellenny

Early elective deliveries – inductions and cesarean deliveries before 39 weeks’ gestation – account for nearly 9% of the singleton births paid for under the Medicaid program, according to an analysis published in the December issue of Health Affairs.*

The rate of early elective deliveries has improved over the last few years, falling by nearly a third among Medicaid-financed births between 2007 and 2011 (Health Aff. 2014;33:2170-8).

©Fuse/Thinkstockphotos.com

Medicaid medical directors in Ohio and Minnesota, working with staff members of AcademyHealth, compared birth certificate data and hospital records from 22 states to determine the rate of early elective deliveries from 2010-2012. Twelve states also provided trend data or 2007-2011.

Of the more than 800,000 singleton births paid for by the Medicaid program across the 22 states, about 32% were elective deliveries and nearly 9% were early-term elective deliveries.

Elective cesarean deliveries were more common than were elective labor inductions before 39 weeks’ gestation. And early elective deliveries increased with maternal age. Mothers older than 34 years had the highest rate at 12.7%. Mothers younger than 20 years had the lowest rate at 6.6%. Early elective deliveries were also higher among women with a history of cesarean delivery.

Over the last few years, there has been a steady push to reduce nonmedically indicated early deliveries. Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine say that early elective deliveries are not appropriate.

The federal government is also getting involved. In 2012, the Centers for Medicare & Medicaid Services joined other federal health agencies to launch the Strong Start for Mothers and Newborns Initiative, aimed at reducing early elective deliveries. And decreasing the rate of early elective deliveries is a priority measure in the CMS initial Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid.

More than 20 state Medicaid programs have also implemented policies that discourage early elective deliveries, ranging from clinical education to partnering with hospitals on “hard stop” policies that bar scheduling of deliveries before 39 weeks without documentation of medical necessity.

While the rate of early elective deliveries has been falling since 2007, the researchers could not pinpoint which strategy is most effective, since most of the efforts are new.

*Correction, 1/30/2015: An earlier version of this story misstated the definition of early elective deliveries.

[email protected]

On Twitter @maryellenny

Early elective deliveries – inductions and cesarean deliveries before 39 weeks’ gestation – account for nearly 9% of the singleton births paid for under the Medicaid program, according to an analysis published in the December issue of Health Affairs.*

The rate of early elective deliveries has improved over the last few years, falling by nearly a third among Medicaid-financed births between 2007 and 2011 (Health Aff. 2014;33:2170-8).

©Fuse/Thinkstockphotos.com

Medicaid medical directors in Ohio and Minnesota, working with staff members of AcademyHealth, compared birth certificate data and hospital records from 22 states to determine the rate of early elective deliveries from 2010-2012. Twelve states also provided trend data or 2007-2011.

Of the more than 800,000 singleton births paid for by the Medicaid program across the 22 states, about 32% were elective deliveries and nearly 9% were early-term elective deliveries.

Elective cesarean deliveries were more common than were elective labor inductions before 39 weeks’ gestation. And early elective deliveries increased with maternal age. Mothers older than 34 years had the highest rate at 12.7%. Mothers younger than 20 years had the lowest rate at 6.6%. Early elective deliveries were also higher among women with a history of cesarean delivery.

Over the last few years, there has been a steady push to reduce nonmedically indicated early deliveries. Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine say that early elective deliveries are not appropriate.

The federal government is also getting involved. In 2012, the Centers for Medicare & Medicaid Services joined other federal health agencies to launch the Strong Start for Mothers and Newborns Initiative, aimed at reducing early elective deliveries. And decreasing the rate of early elective deliveries is a priority measure in the CMS initial Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid.

More than 20 state Medicaid programs have also implemented policies that discourage early elective deliveries, ranging from clinical education to partnering with hospitals on “hard stop” policies that bar scheduling of deliveries before 39 weeks without documentation of medical necessity.

While the rate of early elective deliveries has been falling since 2007, the researchers could not pinpoint which strategy is most effective, since most of the efforts are new.

*Correction, 1/30/2015: An earlier version of this story misstated the definition of early elective deliveries.

[email protected]

On Twitter @maryellenny

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

[email protected]

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

[email protected]

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

[email protected]

PHILADELPHIA – Renal biopsies are a useful tool for optimizing outcomes in pregnant patients with active lupus nephritis, according to Dr. Derek M. Fine.

Although caution is advisable, a general aversion to biopsying pregnant patients is unwarranted, Dr. Fine of Johns Hopkins University, Baltimore, said at the meeting, sponsored by the American Society of Nephrology.

An important question to ask yourself when deciding if a biopsy should be performed is whether without it you will really know what you are treating.

“For me, it’s very, very scary to take care of a lupus patient when I don’t know what’s going on,” said Dr. Fine, director of the Nephrology Fellowship Program at Johns Hopkins.

Other important questions include whether findings on biopsy will change your management, and whether prior histopathology can help you identify the current problem.

“I would say if it was in the previous few months, yes it’s going to be useful. But once you’re 6 months or a year out, you don’t know what’s going on,” he said, noting that while an educated guess can be made that something similar is going on, one can’t rely on prior histopathology in such cases.

“I’m not saying do it with reckless abandon, but think about doing a biopsy,” he said.

An important benefit of performing a biopsy is disease classification to guide management. Another is differential diagnosis, he said, noting that between 20% and 50% of lupus patients have antiphospholipid antibodies, and that a biopsy can also detect thrombi in the kidney, differentiate preeclampsia if there’s a question about that, and identify focal segmental glomerulosclerosis, which is not an uncommon diagnosis on biopsy in African American patients.

As for the risks of biopsying a pregnant patient, the data are sparse – the largest available study was conducted 27 years ago – but they suggest that complication rates with biopsy during pregnancy are low, and that fetal loss is extremely unusual.

Concerns about preterm labor are often cited as a reason to avoid biopsy, but kidney biopsies are not particularly stress inducing. Bleeding is a concern, but bleeding risk has declined over time, and the procedure has become safer with the use of real-time ultrasound and smaller-gauge needles.

“Doppler technology can tell me there is a bleed, often right away, and interventional radiology availability, compared with 1987, is significant. It was really in its infancy back then, but now to get an angiogram is pretty easy and I can get it done within an hour of doing a kidney biopsy,” he said.

Furthermore, pregnant patients tend to have improved coagulation, and thus reduced bleeding risk, although increased renal blood flow may counteract some of that benefit.

In one study, he and his colleagues found that the risk of bleeding was not much different in lupus and nonlupus patients, at about 2.7%, and the risk was reduced by 50% among those with platelet counts greater than 100,000/mm³, he said.

However, the complication rate seen in patients who undergo biopsy is not insignificant, and these patients should be monitored extremely closely after the procedure.

“It’s a low risk, but a real one,” he said.

The literature documents biopsies performed at up to 32 weeks’ gestation, but biopsy may not be worthwhile later in pregnancy when empiric therapy is more reasonable because of a shorter course, and because the fetus is more viable, he said.

Also, if a bleeding event requiring an angiogram occurs, it is easiest to shield the fetus with lead up to about 24 weeks’ gestation. After that point, it can be more difficult to shield the fetus because of positioning, and this should be taken into consideration.

“I get a little bit nervous doing a kidney biopsy beyond 24 weeks, mainly for this reason,” he said.

If necessary, however, a biopsy can be performed up to 28 weeks’ gestation, he added.

Keep in mind that histopathology cannot be predicted based on clinical features alone. “We really need to get tissue to know what we’re treating,” he said, describing patients with similar clinical features, but different histopathology as an example of why biopsy is important.

A one-size-fits-all approach to treatment doesn’t work under these circumstances; biopsy can help spare patients unnecessary or dangerous treatments, and can help optimize treatment to improve outcomes, he said.

He recommended doing a biopsy for proteinuria of 500 mg/dL or more, avoiding biopsy beyond 28 weeks’ gestation, minimizing bleeding risk, and – from a medicolegal standpoint – ensuring fetal well-being before biopsy to ensure that the biopsy is not blamed for fetal death.

If a biopsy is not possible, make an educated guess as to what you think is going on, and treat accordingly, he said.

“The consensus is that active disease is bad for both fetal and maternal outcomes, and that pregnancy makes lupus worse,” he said, noting that studies have shown that only about 10% of women with active disease achieve a term pregnancy, more than half have a preterm birth, and more than a third experience fetal loss.

Ideally, disease activity would be optimized prior to pregnancy in a patient with lupus, as outcomes are vastly improved by a quiescent disease state, but when this is not successful or possible and a patient presents with pregnancy and active disease, a biopsy should be considered, he said.

Dr. Fine said he had no relevant financial disclosures.

PHILADELPHIA – Renal biopsies are a useful tool for optimizing outcomes in pregnant patients with active lupus nephritis, according to Dr. Derek M. Fine.

Although caution is advisable, a general aversion to biopsying pregnant patients is unwarranted, Dr. Fine of Johns Hopkins University, Baltimore, said at the meeting, sponsored by the American Society of Nephrology.

An important question to ask yourself when deciding if a biopsy should be performed is whether without it you will really know what you are treating.

“For me, it’s very, very scary to take care of a lupus patient when I don’t know what’s going on,” said Dr. Fine, director of the Nephrology Fellowship Program at Johns Hopkins.

Other important questions include whether findings on biopsy will change your management, and whether prior histopathology can help you identify the current problem.

“I would say if it was in the previous few months, yes it’s going to be useful. But once you’re 6 months or a year out, you don’t know what’s going on,” he said, noting that while an educated guess can be made that something similar is going on, one can’t rely on prior histopathology in such cases.

“I’m not saying do it with reckless abandon, but think about doing a biopsy,” he said.

An important benefit of performing a biopsy is disease classification to guide management. Another is differential diagnosis, he said, noting that between 20% and 50% of lupus patients have antiphospholipid antibodies, and that a biopsy can also detect thrombi in the kidney, differentiate preeclampsia if there’s a question about that, and identify focal segmental glomerulosclerosis, which is not an uncommon diagnosis on biopsy in African American patients.

As for the risks of biopsying a pregnant patient, the data are sparse – the largest available study was conducted 27 years ago – but they suggest that complication rates with biopsy during pregnancy are low, and that fetal loss is extremely unusual.

Concerns about preterm labor are often cited as a reason to avoid biopsy, but kidney biopsies are not particularly stress inducing. Bleeding is a concern, but bleeding risk has declined over time, and the procedure has become safer with the use of real-time ultrasound and smaller-gauge needles.

“Doppler technology can tell me there is a bleed, often right away, and interventional radiology availability, compared with 1987, is significant. It was really in its infancy back then, but now to get an angiogram is pretty easy and I can get it done within an hour of doing a kidney biopsy,” he said.

Furthermore, pregnant patients tend to have improved coagulation, and thus reduced bleeding risk, although increased renal blood flow may counteract some of that benefit.

In one study, he and his colleagues found that the risk of bleeding was not much different in lupus and nonlupus patients, at about 2.7%, and the risk was reduced by 50% among those with platelet counts greater than 100,000/mm³, he said.

However, the complication rate seen in patients who undergo biopsy is not insignificant, and these patients should be monitored extremely closely after the procedure.

“It’s a low risk, but a real one,” he said.

The literature documents biopsies performed at up to 32 weeks’ gestation, but biopsy may not be worthwhile later in pregnancy when empiric therapy is more reasonable because of a shorter course, and because the fetus is more viable, he said.

Also, if a bleeding event requiring an angiogram occurs, it is easiest to shield the fetus with lead up to about 24 weeks’ gestation. After that point, it can be more difficult to shield the fetus because of positioning, and this should be taken into consideration.

“I get a little bit nervous doing a kidney biopsy beyond 24 weeks, mainly for this reason,” he said.

If necessary, however, a biopsy can be performed up to 28 weeks’ gestation, he added.

Keep in mind that histopathology cannot be predicted based on clinical features alone. “We really need to get tissue to know what we’re treating,” he said, describing patients with similar clinical features, but different histopathology as an example of why biopsy is important.

A one-size-fits-all approach to treatment doesn’t work under these circumstances; biopsy can help spare patients unnecessary or dangerous treatments, and can help optimize treatment to improve outcomes, he said.

He recommended doing a biopsy for proteinuria of 500 mg/dL or more, avoiding biopsy beyond 28 weeks’ gestation, minimizing bleeding risk, and – from a medicolegal standpoint – ensuring fetal well-being before biopsy to ensure that the biopsy is not blamed for fetal death.

If a biopsy is not possible, make an educated guess as to what you think is going on, and treat accordingly, he said.

“The consensus is that active disease is bad for both fetal and maternal outcomes, and that pregnancy makes lupus worse,” he said, noting that studies have shown that only about 10% of women with active disease achieve a term pregnancy, more than half have a preterm birth, and more than a third experience fetal loss.

Ideally, disease activity would be optimized prior to pregnancy in a patient with lupus, as outcomes are vastly improved by a quiescent disease state, but when this is not successful or possible and a patient presents with pregnancy and active disease, a biopsy should be considered, he said.

Dr. Fine said he had no relevant financial disclosures.

PHILADELPHIA – Renal biopsies are a useful tool for optimizing outcomes in pregnant patients with active lupus nephritis, according to Dr. Derek M. Fine.

Although caution is advisable, a general aversion to biopsying pregnant patients is unwarranted, Dr. Fine of Johns Hopkins University, Baltimore, said at the meeting, sponsored by the American Society of Nephrology.

An important question to ask yourself when deciding if a biopsy should be performed is whether without it you will really know what you are treating.

“For me, it’s very, very scary to take care of a lupus patient when I don’t know what’s going on,” said Dr. Fine, director of the Nephrology Fellowship Program at Johns Hopkins.

Other important questions include whether findings on biopsy will change your management, and whether prior histopathology can help you identify the current problem.

“I would say if it was in the previous few months, yes it’s going to be useful. But once you’re 6 months or a year out, you don’t know what’s going on,” he said, noting that while an educated guess can be made that something similar is going on, one can’t rely on prior histopathology in such cases.

“I’m not saying do it with reckless abandon, but think about doing a biopsy,” he said.

An important benefit of performing a biopsy is disease classification to guide management. Another is differential diagnosis, he said, noting that between 20% and 50% of lupus patients have antiphospholipid antibodies, and that a biopsy can also detect thrombi in the kidney, differentiate preeclampsia if there’s a question about that, and identify focal segmental glomerulosclerosis, which is not an uncommon diagnosis on biopsy in African American patients.

As for the risks of biopsying a pregnant patient, the data are sparse – the largest available study was conducted 27 years ago – but they suggest that complication rates with biopsy during pregnancy are low, and that fetal loss is extremely unusual.

Concerns about preterm labor are often cited as a reason to avoid biopsy, but kidney biopsies are not particularly stress inducing. Bleeding is a concern, but bleeding risk has declined over time, and the procedure has become safer with the use of real-time ultrasound and smaller-gauge needles.

“Doppler technology can tell me there is a bleed, often right away, and interventional radiology availability, compared with 1987, is significant. It was really in its infancy back then, but now to get an angiogram is pretty easy and I can get it done within an hour of doing a kidney biopsy,” he said.

Furthermore, pregnant patients tend to have improved coagulation, and thus reduced bleeding risk, although increased renal blood flow may counteract some of that benefit.

In one study, he and his colleagues found that the risk of bleeding was not much different in lupus and nonlupus patients, at about 2.7%, and the risk was reduced by 50% among those with platelet counts greater than 100,000/mm³, he said.

However, the complication rate seen in patients who undergo biopsy is not insignificant, and these patients should be monitored extremely closely after the procedure.

“It’s a low risk, but a real one,” he said.

The literature documents biopsies performed at up to 32 weeks’ gestation, but biopsy may not be worthwhile later in pregnancy when empiric therapy is more reasonable because of a shorter course, and because the fetus is more viable, he said.

Also, if a bleeding event requiring an angiogram occurs, it is easiest to shield the fetus with lead up to about 24 weeks’ gestation. After that point, it can be more difficult to shield the fetus because of positioning, and this should be taken into consideration.

“I get a little bit nervous doing a kidney biopsy beyond 24 weeks, mainly for this reason,” he said.

If necessary, however, a biopsy can be performed up to 28 weeks’ gestation, he added.

Keep in mind that histopathology cannot be predicted based on clinical features alone. “We really need to get tissue to know what we’re treating,” he said, describing patients with similar clinical features, but different histopathology as an example of why biopsy is important.

A one-size-fits-all approach to treatment doesn’t work under these circumstances; biopsy can help spare patients unnecessary or dangerous treatments, and can help optimize treatment to improve outcomes, he said.

He recommended doing a biopsy for proteinuria of 500 mg/dL or more, avoiding biopsy beyond 28 weeks’ gestation, minimizing bleeding risk, and – from a medicolegal standpoint – ensuring fetal well-being before biopsy to ensure that the biopsy is not blamed for fetal death.

If a biopsy is not possible, make an educated guess as to what you think is going on, and treat accordingly, he said.

“The consensus is that active disease is bad for both fetal and maternal outcomes, and that pregnancy makes lupus worse,” he said, noting that studies have shown that only about 10% of women with active disease achieve a term pregnancy, more than half have a preterm birth, and more than a third experience fetal loss.

Ideally, disease activity would be optimized prior to pregnancy in a patient with lupus, as outcomes are vastly improved by a quiescent disease state, but when this is not successful or possible and a patient presents with pregnancy and active disease, a biopsy should be considered, he said.

Dr. Fine said he had no relevant financial disclosures.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

Neuraxial anesthesia, including epidural and combined spinal-epidural anesthetics, are the “gold standard” interventions for pain relief during labor because they provide a superb combination of reliable pain relief and safety for the mother and child.¹ Many US birthing centers also offer additional options for managing labor pain, including continuous labor support,² hydrotherapy,³ and parenteral opioids.⁴ In 2012, the US Food and Drug Administration (FDA) approved equipment to deliver a mixture of 50% nitrous oxide and 50% oxygen, which has offered a new option for laboring mothers.

Nitrous oxide is widely used for labor pain in the United Kingdom, Finland, Sweden, Canada, Australia, and New Zealand.⁵ In the United States, nitrous oxide has been a long-standing and common adjunct to general anesthetics, although it recently has fallen out of favor in place of better, more rapidly acting inhalation and intravenous general anesthetics. With these agents not suitable for labor analgesic use, however, nitrous oxide is undergoing a resurgence in popularity for obstetric analgesia in the United States, and we believe that it will evolve to have a prominent place among our interventions for labor pain.⁶ In this editorial, we detail the mechanism of action and the equipment’s use, as well as benefits for patients and cautions for clinicians.

How does nitrous oxide work?
Pharmacology. Nitrous oxide (N₂O) was first synthesized by Joseph Priestley in 1772 and was used as an anesthetic for dental surgery in the mid-1800s. In the late 19th Century, nitrous oxide was tested as an agent for labor analgesia.⁷ It was introduced into clinical practice in the United Kingdom in the 1930s.⁸

The mechanism of action of nitrous oxide is not fully characterized. It is thought that the gas may produce analgesia by activating the endo­genous opioid and noradrenergic systems, which in turn, modulate spinal cord transmission of pain signals.⁵

Administration to the laboring mother. For labor analgesia, nitrous oxide is typically administered as a mix of 50% N₂O and 50% O₂ using a portable unit with a gas mixer that is fed by small tanks of N₂O and O₂ or with a valve fed by a single tank containing a mixture of both N₂O and O₂. The portable units approved by the FDA contain an oxygen fail-safe system that ensures delivery of an appropriate oxygen concentration. The portable unit also contains a gas scavenging system that is attached to wall suction. The breathing circuit has a mask or a mouthpiece (according to patient preference) and demand valve. The patient places the mask over her nose and mouth, or uses just her mouth for the mouthpiece. With inhalation, the demand valve opens, releasing the gas mixture. On exhalation, the valve shunts the exhaled gases to the scavenging system.

Proper and safe use requires adherence to the principles of a true “patient-controlled” protocol. Only the patient is permitted to place the mask or mouthpiece over her nose and/or mouth. If the patient becomes drowsy, such that she cannot hold the mask to her face, then the internal demand valve will not deliver nitrous oxide and she will return to breathing room air. No one should hold the mask over the patient’s nose or mouth, and the mask should not be fixed in place with elastic bands because these actions may result in the inhalation of too much nitrous oxide.

Nitrous oxide has a rapid onset of action after inhalation and its action quickly dissipates after discontinuing inhalation. There is likely a dose-response relationship, with greater use of the nitrous oxide producing more drowsiness. With the intermittent inhalation method, the laboring patient using nitrous oxide is advised to initiate inhalation of nitrous oxide about 30 seconds before the onset of a contraction and discontinue inhalation at the peak of the contraction.

There is no time limit to the use of nitrous oxide. It can be used for hours during labor or only briefly for a particularly painful part of labor, such as during rapid cervical ­dilation or during the later portions of the second stage.

Patients report that nitrous oxide does not completely relieve pain but creates a diminished perception of the pain.⁹ As many as one-third of women are nonresponders and report no significant pain improvement with nitrous oxide use.¹⁰

The main side effects of inhalation of the gas are nausea, vomiting, dizziness, and drowsiness. Nausea has been reported in 5% to 40% of women, and vomiting has been reported in up to 15% of women using nitrous oxide.¹¹

Cautions
Contraindications to nitrous oxide include a baseline arterial oxygenation saturation less than 95% on room air, acute asthma, emphysema, or pneumothorax, or any other air-filled compartment within the body, such as bowel obstruction or pneumocephalus. (Nitrous oxide can displace nitrogen from closed body spaces, which may lead to an increase in the volume of the closed space.¹²)

Nitrous oxide inactivates ­vitamin B₁₂ by oxidation; therefore, vitamin B₁₂ deficiency or related disorders may be considered a relative contraindication. However, compared with more extensive continuous use, such as during prolonged general anesthesia, intermittent use for a limited time during labor is associated with minimal to no hematologic effects.

If a laboring woman is using N₂O, parenteral opioids should be administered only with great caution by an experienced ­clinician.

What do the data indicate?
The Agency for Healthcare Research and Quality (AHRQ) recently invited the Vanderbilt Evidence-based Practice Center to review the world literature on nitrous oxide for labor pain and to provide a summary of the research. Fifty-eight publications were identified, with 46 rated as poor quality.^11,13 Given this overall poor quality of available research, many of the recommendations concerning the use of nitrous oxide for labor pain are based on clinical ­experience and expert opinion.

The experts concluded that, for the relief of labor pain, neuraxial anesthesia was more effective than nitrous oxide inhalation. In one randomized trial included in their systematic review, nulliparous laboring women were randomly assigned to neuraxial anesthesia or nitrous oxide plus meperidine.¹⁴ About 94% of nulliparous laboring women reported satisfaction with neuraxial anesthesia, compared with 54% treated with nitrous oxide and meperidine.¹⁴

Nitrous oxide is believed to be generally safe for mother and fetus. Its use does not impact the ­newborn Apgar score¹⁵ or alter uterine
contractility.¹⁶

Catherine McGovern, RN, MSN, CNM

1. Do your research to determine which type of equipment is right for the size and volume of your organization.
   You need to consider ease of access and use for staff to bring this option to the bedside in a prompt and safe manner. Initial research includes visiting or speaking with practitioners on units currently using nitrous oxide. Use of nitrous oxide is growing, and networking is helpful in terms of planning your program. Making sure you have the correct gas line connectors for oxygen as well as for suction when using a scavenger system is a preliminary necessity.
   
   
2. Determine storage ability.
   Your environmental safety officer is a good resource to determine location and regulations regarding safe storage as well as tank capacity. He or she also can help you determine where else in your organization nitrous oxide is used so you may be able to develop your unit-specific protocol from hospital-wide policy that is already in place.
   
   
3. Collaborate on a protocol.
   After determining which type of equipment is best for you, propose the idea to committees that can contribute to the development of pain and sedation management protocols. The anesthesia department, pain committee, and postoperative pain management teams are knowledgeable resources and can help you write a safe protocol. Keep as the main focus the safe application and use of nitrous oxide for various patient populations. Potential medication interactions and contraindications for use should be discussed and included in a protocol.
   
   One more department you want to include in your planning is infection control. For our unit, reviewing various types of equipment to determine the best infection control revealed some interesting design benefits to reduce infection risk. Because the nitrous oxide equipment would be mobile, the types of filter options, disposal options, and cleaning ability are important components for final equipment choice.
   
   
4. Include all parties in training and final roll out.
   Once you develop your policy with input from all stakeholders, make sure you share it early and often before you go live. Include midwives, physicians, nurses, technicians, and administrative staff in training, which will help to dispel myths and increase awareness of availability within your unit. Provide background information to all trainees to ensure safe use and appropriate patient selection.
   
   The most important determinant of success is the formation of an inter­professional team that works well together to develop a safe clinician- and patient-friendly program for the use of nitrous oxide.

Nitrous oxide, a bridge to an epidural or a natural childbirth
Many women start labor unsure about whether they want to use an epidural. For these women, nitrous oxide may be an option for reducing labor pain, thereby giving the woman more time to make a decision about whether to have an epidural anesthetic. In our practice, a significant percentage of women who use nitrous oxide early in labor subsequently request a neuraxial anesthetic. However, many women planning natural childbirth use nitrous oxide to reduce labor pain and successfully achieve their goal.

Postpartum pain reliever
Some women deliver without the use of any pain medicine. Sometimes birth is complicated by perineal lacerations requiring significant surgical repair. If a woman does not have adequate analgesia after injection of a local anesthetic, nitrous oxide may help reduce her pain during the perineal repair and facilitate quick completion of the procedure by allowing her to remain still. N₂O also has been used to facilitate analgesia during manual removal of the placenta.

We predict an expanding role
There are many pharmacologic and nonpharmacologic options for managing labor pain, including a supportive birth environment, touch and massage, maternal positioning, relaxation and breathing techniques, continuous labor support, hydrotherapy, opioids, and neuraxial anesthesia. Midwives, labor nurses, and physicians have championed increasing the availability of nitrous oxide to laboring women in US birthing centers.^17–20 With the FDA approval of inexpensive portable nitrous oxide units, it is likely that we will witness a resurgence of its use and gain important clinical experience in the role of nitrous oxide for managing labor pain.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Neuraxial anesthesia, including epidural and combined spinal-epidural anesthetics, are the “gold standard” interventions for pain relief during labor because they provide a superb combination of reliable pain relief and safety for the mother and child.¹ Many US birthing centers also offer additional options for managing labor pain, including continuous labor support,² hydrotherapy,³ and parenteral opioids.⁴ In 2012, the US Food and Drug Administration (FDA) approved equipment to deliver a mixture of 50% nitrous oxide and 50% oxygen, which has offered a new option for laboring mothers.

Nitrous oxide is widely used for labor pain in the United Kingdom, Finland, Sweden, Canada, Australia, and New Zealand.⁵ In the United States, nitrous oxide has been a long-standing and common adjunct to general anesthetics, although it recently has fallen out of favor in place of better, more rapidly acting inhalation and intravenous general anesthetics. With these agents not suitable for labor analgesic use, however, nitrous oxide is undergoing a resurgence in popularity for obstetric analgesia in the United States, and we believe that it will evolve to have a prominent place among our interventions for labor pain.⁶ In this editorial, we detail the mechanism of action and the equipment’s use, as well as benefits for patients and cautions for clinicians.

How does nitrous oxide work?
Pharmacology. Nitrous oxide (N₂O) was first synthesized by Joseph Priestley in 1772 and was used as an anesthetic for dental surgery in the mid-1800s. In the late 19th Century, nitrous oxide was tested as an agent for labor analgesia.⁷ It was introduced into clinical practice in the United Kingdom in the 1930s.⁸

The mechanism of action of nitrous oxide is not fully characterized. It is thought that the gas may produce analgesia by activating the endo­genous opioid and noradrenergic systems, which in turn, modulate spinal cord transmission of pain signals.⁵

Administration to the laboring mother. For labor analgesia, nitrous oxide is typically administered as a mix of 50% N₂O and 50% O₂ using a portable unit with a gas mixer that is fed by small tanks of N₂O and O₂ or with a valve fed by a single tank containing a mixture of both N₂O and O₂. The portable units approved by the FDA contain an oxygen fail-safe system that ensures delivery of an appropriate oxygen concentration. The portable unit also contains a gas scavenging system that is attached to wall suction. The breathing circuit has a mask or a mouthpiece (according to patient preference) and demand valve. The patient places the mask over her nose and mouth, or uses just her mouth for the mouthpiece. With inhalation, the demand valve opens, releasing the gas mixture. On exhalation, the valve shunts the exhaled gases to the scavenging system.

Proper and safe use requires adherence to the principles of a true “patient-controlled” protocol. Only the patient is permitted to place the mask or mouthpiece over her nose and/or mouth. If the patient becomes drowsy, such that she cannot hold the mask to her face, then the internal demand valve will not deliver nitrous oxide and she will return to breathing room air. No one should hold the mask over the patient’s nose or mouth, and the mask should not be fixed in place with elastic bands because these actions may result in the inhalation of too much nitrous oxide.

Nitrous oxide has a rapid onset of action after inhalation and its action quickly dissipates after discontinuing inhalation. There is likely a dose-response relationship, with greater use of the nitrous oxide producing more drowsiness. With the intermittent inhalation method, the laboring patient using nitrous oxide is advised to initiate inhalation of nitrous oxide about 30 seconds before the onset of a contraction and discontinue inhalation at the peak of the contraction.

There is no time limit to the use of nitrous oxide. It can be used for hours during labor or only briefly for a particularly painful part of labor, such as during rapid cervical ­dilation or during the later portions of the second stage.

Patients report that nitrous oxide does not completely relieve pain but creates a diminished perception of the pain.⁹ As many as one-third of women are nonresponders and report no significant pain improvement with nitrous oxide use.¹⁰

The main side effects of inhalation of the gas are nausea, vomiting, dizziness, and drowsiness. Nausea has been reported in 5% to 40% of women, and vomiting has been reported in up to 15% of women using nitrous oxide.¹¹

Cautions
Contraindications to nitrous oxide include a baseline arterial oxygenation saturation less than 95% on room air, acute asthma, emphysema, or pneumothorax, or any other air-filled compartment within the body, such as bowel obstruction or pneumocephalus. (Nitrous oxide can displace nitrogen from closed body spaces, which may lead to an increase in the volume of the closed space.¹²)

Nitrous oxide inactivates ­vitamin B₁₂ by oxidation; therefore, vitamin B₁₂ deficiency or related disorders may be considered a relative contraindication. However, compared with more extensive continuous use, such as during prolonged general anesthesia, intermittent use for a limited time during labor is associated with minimal to no hematologic effects.

If a laboring woman is using N₂O, parenteral opioids should be administered only with great caution by an experienced ­clinician.

What do the data indicate?
The Agency for Healthcare Research and Quality (AHRQ) recently invited the Vanderbilt Evidence-based Practice Center to review the world literature on nitrous oxide for labor pain and to provide a summary of the research. Fifty-eight publications were identified, with 46 rated as poor quality.^11,13 Given this overall poor quality of available research, many of the recommendations concerning the use of nitrous oxide for labor pain are based on clinical ­experience and expert opinion.

The experts concluded that, for the relief of labor pain, neuraxial anesthesia was more effective than nitrous oxide inhalation. In one randomized trial included in their systematic review, nulliparous laboring women were randomly assigned to neuraxial anesthesia or nitrous oxide plus meperidine.¹⁴ About 94% of nulliparous laboring women reported satisfaction with neuraxial anesthesia, compared with 54% treated with nitrous oxide and meperidine.¹⁴

Nitrous oxide is believed to be generally safe for mother and fetus. Its use does not impact the ­newborn Apgar score¹⁵ or alter uterine
contractility.¹⁶

Catherine McGovern, RN, MSN, CNM

1. Do your research to determine which type of equipment is right for the size and volume of your organization.
   You need to consider ease of access and use for staff to bring this option to the bedside in a prompt and safe manner. Initial research includes visiting or speaking with practitioners on units currently using nitrous oxide. Use of nitrous oxide is growing, and networking is helpful in terms of planning your program. Making sure you have the correct gas line connectors for oxygen as well as for suction when using a scavenger system is a preliminary necessity.
   
   
2. Determine storage ability.
   Your environmental safety officer is a good resource to determine location and regulations regarding safe storage as well as tank capacity. He or she also can help you determine where else in your organization nitrous oxide is used so you may be able to develop your unit-specific protocol from hospital-wide policy that is already in place.
   
   
3. Collaborate on a protocol.
   After determining which type of equipment is best for you, propose the idea to committees that can contribute to the development of pain and sedation management protocols. The anesthesia department, pain committee, and postoperative pain management teams are knowledgeable resources and can help you write a safe protocol. Keep as the main focus the safe application and use of nitrous oxide for various patient populations. Potential medication interactions and contraindications for use should be discussed and included in a protocol.
   
   One more department you want to include in your planning is infection control. For our unit, reviewing various types of equipment to determine the best infection control revealed some interesting design benefits to reduce infection risk. Because the nitrous oxide equipment would be mobile, the types of filter options, disposal options, and cleaning ability are important components for final equipment choice.
   
   
4. Include all parties in training and final roll out.
   Once you develop your policy with input from all stakeholders, make sure you share it early and often before you go live. Include midwives, physicians, nurses, technicians, and administrative staff in training, which will help to dispel myths and increase awareness of availability within your unit. Provide background information to all trainees to ensure safe use and appropriate patient selection.
   
   The most important determinant of success is the formation of an inter­professional team that works well together to develop a safe clinician- and patient-friendly program for the use of nitrous oxide.

Nitrous oxide, a bridge to an epidural or a natural childbirth
Many women start labor unsure about whether they want to use an epidural. For these women, nitrous oxide may be an option for reducing labor pain, thereby giving the woman more time to make a decision about whether to have an epidural anesthetic. In our practice, a significant percentage of women who use nitrous oxide early in labor subsequently request a neuraxial anesthetic. However, many women planning natural childbirth use nitrous oxide to reduce labor pain and successfully achieve their goal.

Postpartum pain reliever
Some women deliver without the use of any pain medicine. Sometimes birth is complicated by perineal lacerations requiring significant surgical repair. If a woman does not have adequate analgesia after injection of a local anesthetic, nitrous oxide may help reduce her pain during the perineal repair and facilitate quick completion of the procedure by allowing her to remain still. N₂O also has been used to facilitate analgesia during manual removal of the placenta.

We predict an expanding role
There are many pharmacologic and nonpharmacologic options for managing labor pain, including a supportive birth environment, touch and massage, maternal positioning, relaxation and breathing techniques, continuous labor support, hydrotherapy, opioids, and neuraxial anesthesia. Midwives, labor nurses, and physicians have championed increasing the availability of nitrous oxide to laboring women in US birthing centers.^17–20 With the FDA approval of inexpensive portable nitrous oxide units, it is likely that we will witness a resurgence of its use and gain important clinical experience in the role of nitrous oxide for managing labor pain.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Neuraxial anesthesia, including epidural and combined spinal-epidural anesthetics, are the “gold standard” interventions for pain relief during labor because they provide a superb combination of reliable pain relief and safety for the mother and child.¹ Many US birthing centers also offer additional options for managing labor pain, including continuous labor support,² hydrotherapy,³ and parenteral opioids.⁴ In 2012, the US Food and Drug Administration (FDA) approved equipment to deliver a mixture of 50% nitrous oxide and 50% oxygen, which has offered a new option for laboring mothers.

Nitrous oxide is widely used for labor pain in the United Kingdom, Finland, Sweden, Canada, Australia, and New Zealand.⁵ In the United States, nitrous oxide has been a long-standing and common adjunct to general anesthetics, although it recently has fallen out of favor in place of better, more rapidly acting inhalation and intravenous general anesthetics. With these agents not suitable for labor analgesic use, however, nitrous oxide is undergoing a resurgence in popularity for obstetric analgesia in the United States, and we believe that it will evolve to have a prominent place among our interventions for labor pain.⁶ In this editorial, we detail the mechanism of action and the equipment’s use, as well as benefits for patients and cautions for clinicians.

How does nitrous oxide work?
Pharmacology. Nitrous oxide (N₂O) was first synthesized by Joseph Priestley in 1772 and was used as an anesthetic for dental surgery in the mid-1800s. In the late 19th Century, nitrous oxide was tested as an agent for labor analgesia.⁷ It was introduced into clinical practice in the United Kingdom in the 1930s.⁸

The mechanism of action of nitrous oxide is not fully characterized. It is thought that the gas may produce analgesia by activating the endo­genous opioid and noradrenergic systems, which in turn, modulate spinal cord transmission of pain signals.⁵

Administration to the laboring mother. For labor analgesia, nitrous oxide is typically administered as a mix of 50% N₂O and 50% O₂ using a portable unit with a gas mixer that is fed by small tanks of N₂O and O₂ or with a valve fed by a single tank containing a mixture of both N₂O and O₂. The portable units approved by the FDA contain an oxygen fail-safe system that ensures delivery of an appropriate oxygen concentration. The portable unit also contains a gas scavenging system that is attached to wall suction. The breathing circuit has a mask or a mouthpiece (according to patient preference) and demand valve. The patient places the mask over her nose and mouth, or uses just her mouth for the mouthpiece. With inhalation, the demand valve opens, releasing the gas mixture. On exhalation, the valve shunts the exhaled gases to the scavenging system.

Proper and safe use requires adherence to the principles of a true “patient-controlled” protocol. Only the patient is permitted to place the mask or mouthpiece over her nose and/or mouth. If the patient becomes drowsy, such that she cannot hold the mask to her face, then the internal demand valve will not deliver nitrous oxide and she will return to breathing room air. No one should hold the mask over the patient’s nose or mouth, and the mask should not be fixed in place with elastic bands because these actions may result in the inhalation of too much nitrous oxide.

Nitrous oxide has a rapid onset of action after inhalation and its action quickly dissipates after discontinuing inhalation. There is likely a dose-response relationship, with greater use of the nitrous oxide producing more drowsiness. With the intermittent inhalation method, the laboring patient using nitrous oxide is advised to initiate inhalation of nitrous oxide about 30 seconds before the onset of a contraction and discontinue inhalation at the peak of the contraction.

There is no time limit to the use of nitrous oxide. It can be used for hours during labor or only briefly for a particularly painful part of labor, such as during rapid cervical ­dilation or during the later portions of the second stage.

Patients report that nitrous oxide does not completely relieve pain but creates a diminished perception of the pain.⁹ As many as one-third of women are nonresponders and report no significant pain improvement with nitrous oxide use.¹⁰

The main side effects of inhalation of the gas are nausea, vomiting, dizziness, and drowsiness. Nausea has been reported in 5% to 40% of women, and vomiting has been reported in up to 15% of women using nitrous oxide.¹¹

Cautions
Contraindications to nitrous oxide include a baseline arterial oxygenation saturation less than 95% on room air, acute asthma, emphysema, or pneumothorax, or any other air-filled compartment within the body, such as bowel obstruction or pneumocephalus. (Nitrous oxide can displace nitrogen from closed body spaces, which may lead to an increase in the volume of the closed space.¹²)

Nitrous oxide inactivates ­vitamin B₁₂ by oxidation; therefore, vitamin B₁₂ deficiency or related disorders may be considered a relative contraindication. However, compared with more extensive continuous use, such as during prolonged general anesthesia, intermittent use for a limited time during labor is associated with minimal to no hematologic effects.

If a laboring woman is using N₂O, parenteral opioids should be administered only with great caution by an experienced ­clinician.

What do the data indicate?
The Agency for Healthcare Research and Quality (AHRQ) recently invited the Vanderbilt Evidence-based Practice Center to review the world literature on nitrous oxide for labor pain and to provide a summary of the research. Fifty-eight publications were identified, with 46 rated as poor quality.^11,13 Given this overall poor quality of available research, many of the recommendations concerning the use of nitrous oxide for labor pain are based on clinical ­experience and expert opinion.

The experts concluded that, for the relief of labor pain, neuraxial anesthesia was more effective than nitrous oxide inhalation. In one randomized trial included in their systematic review, nulliparous laboring women were randomly assigned to neuraxial anesthesia or nitrous oxide plus meperidine.¹⁴ About 94% of nulliparous laboring women reported satisfaction with neuraxial anesthesia, compared with 54% treated with nitrous oxide and meperidine.¹⁴

Nitrous oxide is believed to be generally safe for mother and fetus. Its use does not impact the ­newborn Apgar score¹⁵ or alter uterine
contractility.¹⁶

Catherine McGovern, RN, MSN, CNM

1. Do your research to determine which type of equipment is right for the size and volume of your organization.
   You need to consider ease of access and use for staff to bring this option to the bedside in a prompt and safe manner. Initial research includes visiting or speaking with practitioners on units currently using nitrous oxide. Use of nitrous oxide is growing, and networking is helpful in terms of planning your program. Making sure you have the correct gas line connectors for oxygen as well as for suction when using a scavenger system is a preliminary necessity.
   
   
2. Determine storage ability.
   Your environmental safety officer is a good resource to determine location and regulations regarding safe storage as well as tank capacity. He or she also can help you determine where else in your organization nitrous oxide is used so you may be able to develop your unit-specific protocol from hospital-wide policy that is already in place.
   
   
3. Collaborate on a protocol.
   After determining which type of equipment is best for you, propose the idea to committees that can contribute to the development of pain and sedation management protocols. The anesthesia department, pain committee, and postoperative pain management teams are knowledgeable resources and can help you write a safe protocol. Keep as the main focus the safe application and use of nitrous oxide for various patient populations. Potential medication interactions and contraindications for use should be discussed and included in a protocol.
   
   One more department you want to include in your planning is infection control. For our unit, reviewing various types of equipment to determine the best infection control revealed some interesting design benefits to reduce infection risk. Because the nitrous oxide equipment would be mobile, the types of filter options, disposal options, and cleaning ability are important components for final equipment choice.
   
   
4. Include all parties in training and final roll out.
   Once you develop your policy with input from all stakeholders, make sure you share it early and often before you go live. Include midwives, physicians, nurses, technicians, and administrative staff in training, which will help to dispel myths and increase awareness of availability within your unit. Provide background information to all trainees to ensure safe use and appropriate patient selection.
   
   The most important determinant of success is the formation of an inter­professional team that works well together to develop a safe clinician- and patient-friendly program for the use of nitrous oxide.

Nitrous oxide, a bridge to an epidural or a natural childbirth
Many women start labor unsure about whether they want to use an epidural. For these women, nitrous oxide may be an option for reducing labor pain, thereby giving the woman more time to make a decision about whether to have an epidural anesthetic. In our practice, a significant percentage of women who use nitrous oxide early in labor subsequently request a neuraxial anesthetic. However, many women planning natural childbirth use nitrous oxide to reduce labor pain and successfully achieve their goal.

Postpartum pain reliever
Some women deliver without the use of any pain medicine. Sometimes birth is complicated by perineal lacerations requiring significant surgical repair. If a woman does not have adequate analgesia after injection of a local anesthetic, nitrous oxide may help reduce her pain during the perineal repair and facilitate quick completion of the procedure by allowing her to remain still. N₂O also has been used to facilitate analgesia during manual removal of the placenta.

We predict an expanding role
There are many pharmacologic and nonpharmacologic options for managing labor pain, including a supportive birth environment, touch and massage, maternal positioning, relaxation and breathing techniques, continuous labor support, hydrotherapy, opioids, and neuraxial anesthesia. Midwives, labor nurses, and physicians have championed increasing the availability of nitrous oxide to laboring women in US birthing centers.^17–20 With the FDA approval of inexpensive portable nitrous oxide units, it is likely that we will witness a resurgence of its use and gain important clinical experience in the role of nitrous oxide for managing labor pain.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The introduction of cell-free fetal DNA (cfDNA) testing has had a tremendous impact on prenatal care. Numerous series reporting near-diagnostic accuracy for trisomy 21 detection have been reported,¹ and several commercial laboratories offer clinical testing. Many patients now take advantage of these tests, and the very low false-positive rates have resulted in a marked decrease in the rate of invasive diagnostic testing.² At present, most professional societies suggest that these tests be reserved for women at high risk for fetal aneuploidy.³

Details of the study
In this recent article by Porreco and colleagues, the researchers reported on a large cohort study of patients who had made the decision to undergo invasive diagnostic testing with chorionic villus sampling or amniocentesis prior to undergoing noninvasive testing, in order to validate the clinical performance of massively parallel genomic sequencing of cfDNA. As in several prior reports, the study authors found that the detection rate of cfDNA for trisomy 21 was 100%, and somewhat less for trisomy 18 (92%) and trisomy 13 (87%). The false-positive rate was very low, with only three false-positive results (all for trisomy 21) in 3,430 patients. Testing for fetal sex chromosomes reported 7 out of 3,322 errors in fetal sex and 100% detection of sex chromosomal aneuploidies, with 16 out of 3,200 false-­positive results.

Study limitations
As in prior reports, limitations to the test were not clearly presented. Patients with “complex chromosomal abnormalities” not detectable by cfDNA were excluded from the reported cohort. Considering these cases, fewer of the total chromosomal abnormalities in the cohort were detected.

Also, adequate fetal DNA is necessary for accurate results, and patients with less than 4% fetal DNA were excluded. Low fetal DNA is associated with an increased risk of trisomy.^4,5 Therefore, excluding such cases will bias results toward a higher detection rate.

The outcomes for cases of low fetal DNA were not included in this study, but in another recent paper 22% of cases of low fetal DNA had aneuploidy, and 16% of common aneuploidies were not detected because of failed testing.⁴

What this evidence means for practice
Cell-free fetal DNA is an exciting technology, and this study adds to the existing literature in the field. However, use of the test requires careful patient counseling regarding the limitations in detecting abnormalities other than trisomy 21, which comprises just 50% of all aneuploidies. Women who desire a comprehensive prenatal genetic assessment may prefer invasive diagnostic testing and should be counseled appropriately. Patients in whom the test fails should be informed that they are at high risk for a chromosomal abnormality.

Considering these outcomes, the benefits of prenatal screening with cfDNA over current testing alternatives, with serum analytes and/or invasive diagnostic testing, become less clear and the options more complex. Of primary importance is that patients understand the risks and benefits of alternative tests.
                                                                                                                                                         —Mary E. Norton, MD 

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The introduction of cell-free fetal DNA (cfDNA) testing has had a tremendous impact on prenatal care. Numerous series reporting near-diagnostic accuracy for trisomy 21 detection have been reported,¹ and several commercial laboratories offer clinical testing. Many patients now take advantage of these tests, and the very low false-positive rates have resulted in a marked decrease in the rate of invasive diagnostic testing.² At present, most professional societies suggest that these tests be reserved for women at high risk for fetal aneuploidy.³

Details of the study
In this recent article by Porreco and colleagues, the researchers reported on a large cohort study of patients who had made the decision to undergo invasive diagnostic testing with chorionic villus sampling or amniocentesis prior to undergoing noninvasive testing, in order to validate the clinical performance of massively parallel genomic sequencing of cfDNA. As in several prior reports, the study authors found that the detection rate of cfDNA for trisomy 21 was 100%, and somewhat less for trisomy 18 (92%) and trisomy 13 (87%). The false-positive rate was very low, with only three false-positive results (all for trisomy 21) in 3,430 patients. Testing for fetal sex chromosomes reported 7 out of 3,322 errors in fetal sex and 100% detection of sex chromosomal aneuploidies, with 16 out of 3,200 false-­positive results.

Study limitations
As in prior reports, limitations to the test were not clearly presented. Patients with “complex chromosomal abnormalities” not detectable by cfDNA were excluded from the reported cohort. Considering these cases, fewer of the total chromosomal abnormalities in the cohort were detected.

Also, adequate fetal DNA is necessary for accurate results, and patients with less than 4% fetal DNA were excluded. Low fetal DNA is associated with an increased risk of trisomy.^4,5 Therefore, excluding such cases will bias results toward a higher detection rate.

The outcomes for cases of low fetal DNA were not included in this study, but in another recent paper 22% of cases of low fetal DNA had aneuploidy, and 16% of common aneuploidies were not detected because of failed testing.⁴

What this evidence means for practice
Cell-free fetal DNA is an exciting technology, and this study adds to the existing literature in the field. However, use of the test requires careful patient counseling regarding the limitations in detecting abnormalities other than trisomy 21, which comprises just 50% of all aneuploidies. Women who desire a comprehensive prenatal genetic assessment may prefer invasive diagnostic testing and should be counseled appropriately. Patients in whom the test fails should be informed that they are at high risk for a chromosomal abnormality.

Considering these outcomes, the benefits of prenatal screening with cfDNA over current testing alternatives, with serum analytes and/or invasive diagnostic testing, become less clear and the options more complex. Of primary importance is that patients understand the risks and benefits of alternative tests.
                                                                                                                                                         —Mary E. Norton, MD 

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The introduction of cell-free fetal DNA (cfDNA) testing has had a tremendous impact on prenatal care. Numerous series reporting near-diagnostic accuracy for trisomy 21 detection have been reported,¹ and several commercial laboratories offer clinical testing. Many patients now take advantage of these tests, and the very low false-positive rates have resulted in a marked decrease in the rate of invasive diagnostic testing.² At present, most professional societies suggest that these tests be reserved for women at high risk for fetal aneuploidy.³

Details of the study
In this recent article by Porreco and colleagues, the researchers reported on a large cohort study of patients who had made the decision to undergo invasive diagnostic testing with chorionic villus sampling or amniocentesis prior to undergoing noninvasive testing, in order to validate the clinical performance of massively parallel genomic sequencing of cfDNA. As in several prior reports, the study authors found that the detection rate of cfDNA for trisomy 21 was 100%, and somewhat less for trisomy 18 (92%) and trisomy 13 (87%). The false-positive rate was very low, with only three false-positive results (all for trisomy 21) in 3,430 patients. Testing for fetal sex chromosomes reported 7 out of 3,322 errors in fetal sex and 100% detection of sex chromosomal aneuploidies, with 16 out of 3,200 false-­positive results.

Study limitations
As in prior reports, limitations to the test were not clearly presented. Patients with “complex chromosomal abnormalities” not detectable by cfDNA were excluded from the reported cohort. Considering these cases, fewer of the total chromosomal abnormalities in the cohort were detected.

Also, adequate fetal DNA is necessary for accurate results, and patients with less than 4% fetal DNA were excluded. Low fetal DNA is associated with an increased risk of trisomy.^4,5 Therefore, excluding such cases will bias results toward a higher detection rate.

The outcomes for cases of low fetal DNA were not included in this study, but in another recent paper 22% of cases of low fetal DNA had aneuploidy, and 16% of common aneuploidies were not detected because of failed testing.⁴

What this evidence means for practice
Cell-free fetal DNA is an exciting technology, and this study adds to the existing literature in the field. However, use of the test requires careful patient counseling regarding the limitations in detecting abnormalities other than trisomy 21, which comprises just 50% of all aneuploidies. Women who desire a comprehensive prenatal genetic assessment may prefer invasive diagnostic testing and should be counseled appropriately. Patients in whom the test fails should be informed that they are at high risk for a chromosomal abnormality.

Considering these outcomes, the benefits of prenatal screening with cfDNA over current testing alternatives, with serum analytes and/or invasive diagnostic testing, become less clear and the options more complex. Of primary importance is that patients understand the risks and benefits of alternative tests.
                                                                                                                                                         —Mary E. Norton, MD 

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“TRANSFER TO THE HOSPITAL FOR WOMEN PLANNING A HOME BIRTH: A HIGH-RISK OBSTETRICS PROBLEM”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2014)

Uterus ruptures at home
A woman (G4P3) had undergone two cesarean deliveries followed by successful vaginal birth after cesarean (VBAC) in hospital. During her second trimester, the patient decided, against the advice of her ObGyn, to have a home delivery. Her midwife was present when, after several hours, the mother felt a sudden sharp pain. When the midwife detected fetal heart-rate tones of 60–70 bpm, she called 911. The patient was transported to the labor and delivery (L&D) unit where I was the in-house ObGyn on call for unattached patients.

In triage, the baby’s heart rate was in the 60-bpm range. I found no presenting part of the fetus on vaginal examination; the patient had a surgical abdomen on palpation. She was immediately taken for an emergency cesarean delivery. We found the baby halfway out of a uterine rupture. The placenta was still partially attached to the fundus. 

The baby’s blood gases were too low to register on the machine. She was resuscitated, but still had no suck or gag reflex when discharged from the neonatal intensive care unit (NICU), with minimal brainstem function.

The mother didn’t require blood products because the rupture was barely bleeding. The uterine rupture occurred over the entire scar area from previous cesarean deliveries. The mother was in our hospital for a total of 14 minutes before delivery occurred.

I have no collaborative agreement with any midwife for accepting their failed home birth attempts. 

Kevin Fulford, MD
San Diego, California

A perfect candidate for home birth?
In my last call as a resident, a patient arrived at L&D after arrest of labor at 5 cm for many hours. The patient was a G1P0 at term with twins and the presenting twin was in a known breech presentation. The patient quickly agreed to a cesarean delivery and has two healthy babies. 

I will never forget the patient’s lay midwife telling me that the mother was the “perfect candidate for a home birth.” She seemed so disappointed by the patient’s decision to head to the hospital. It made for a memorable last night as a resident!

Erinn Hoekstra, MD
Grand Rapids, Michigan

Why women choose out-of-hospital birth
As a Board-Certified ObGyn who attends women at home, at a birthing center, and in hospital, I find this article lacking in two ways: why women choose out-of-hospital birth and why maternal outcomes at home are never discussed. 

Women choose out-of-hospital birth because they are refused meaningful decision making in their labor and birth processes. They are refused VBACs, vaginal delivery of breech presentations, food and drink, and are forced to accept continuous electronic fetal monitoring (EFM), to name but a few. They also choose to stay away from the hospital because of the cascade of unscientific interventions that lead to unnecessary cesarean deliveries.

Noted in the article are neonatal outcomes, but not maternal outcomes, which are universally better outside the hospital. Fewer than 2% of women birth at home. Therefore, they can’t be responsible for the skyrocketing maternal mortality rate, the ever-increasing induction and cesarean delivery rates, and attendant accretas, etc. We have reached the point that Semmelweiss noted in Vienna in the 1800s: women who deliver outside the hospital are less likely to die than those who deliver inside.

So much hand-wringing over the few who stay away from the hospital rather than reforming the practice of obstetrics to make it safer for the majority of women who go to hospital.

Katharine Morrison, MD
The Birthing Center of Buffalo
Buffalo, New York

Dr. Barbieri responds
I appreciate the perspectives and case histories provided by Drs. Fulford, and Hoekstra. As these case reports indicate, home birth can be dangerous for both the newborn and mother. Drs. Fulford, Hoekstra, and I agree with the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) that pregnant women should deliver at certified birth centers or hospital-based obstetrics units in order to optimize outcomes for newborns and mothers. 

Dr. Morrison supports the ACOG and AAP conclusion that women have a right to exercise their autonomy and choose a planned home birth. I know that all clinicians are deeply dedicated to continually advancing the quality of care we provide to pregnant women, regardless of their perspectives on home birth.

“TRANSFORMING VAGINAL HYSTERECTOMY: 7 SOLUTIONS TO THE MOST DAUNTING CHALLENGES”
ROSANNE M. KHO, MD (SURGICAL TECHNIQUES; AUGUST 2014)

Additional tips for vaginal hysterectomy
I concur with Dr. Kho’s recommendations regarding vaginal hysterectomy. Having been in practice for 32 years, I have performed more than 2,000 vaginal hysterectomies and it continues to be my preferred method.

As a volunteer faculty member in the benign gynecology division of a medical school, I am dismayed at the lack of adequate training gynecologists have received upon graduation—admittedly, some because they choose something else or will perform only laparoscopic surgery.

Here are a few tips that I use to improve my success:

• place indigo carmine in the bladder before starting the case
• inject the vaginal mucosa with vasopressin in saline solution to decrease bleeding
• wear a headlamp like vascular surgeons use
• use an electrical sealer (Ligasure Vessel Sealing Generator, Covidien) to reduce knot tying.

I developed what I call a “baby-lap” that is one-third the size of a regular laparotomy that can be used to push the bowel and other organs away to gain better visualization while removing the ovaries and performing a McCall culdoplasty.

I tell residents not to miss these vaginal hysterectomy cases instead of attending lectures, but sometimes it falls in deaf ears. I consider it my moral obligation to pass on this expertise to young gynecologists for the betterment of future generations.

Richard Nuila-Crouse, MD
Houston Texas

Why does vaginal hysterectomy have to be so complicated?
Adding more technology to a formerly straightforward procedure causes additional problems for most vaginal hysterectomies. I am a proponent of the “KISS” (Keep It Simple, Stupid) philosophy!

I don’t agree with several points that Dr. Kho presents in her article and video:

• The Magrina-Bookwalter Retractor as used decreases exposure. On the video, Dr. Kho could not even get her small fingers into the vagina.
• Positioning the surgeon in the upright position (not sitting) makes it much easier to perform the procedure, and aids the assistants.
• Use a headlamp for a better lighting source. A properly fixed overhead lamp can also provide excellent light to the operative field.
• In well over 550 vaginal hysterectomies, I never had to enlarge the introitus with an incision. What were Dr. Kho’s complications by doing so? Has she ever entered the rectal area with this incision?
• In the video, Dr. Kho used a cautery, something that used to be unheard of due to its associated complications. What complications has she had by using it?

New technology has not improved the technique of performing a vaginal hysterectomy. Why make this procedure so complicated when, in reality, it is a simple, straightforward surgical procedure that can usually be performed in less than 60 minutes.

Rudi Ansbacher, MD, MS
Professor Emeritus of Obstetrics and Gynecology
University of Michigan Health System
Ann Arbor, Michigan

Dr. Kho responds
I appreciate the comments of Dr. ­Nuila-Crouse and Dr. Ansbacher.

The “baby-lap” that Dr. Nuila-Crouse describes sounds very similar to the vaginal packing I use, manufactured by Dukal Corporation. It is an 8-ply, 4” x 46” packing that greatly facilitates the case, particularly with the adnexectomy and placement of the sutures on the uterosacral ligaments to support the vaginal apex.

As I mentioned in the article, it is time that we update our techniques and incorporate available surgical innovation and devices to facilitate the vaginal procedure and prevent its continued decline. The use of the Magrina-Bookwalter vaginal retractor system eliminates the need for two bedside assistants. The self-retracting blades are also significantly narrower than the weighted speculum and deaver retractors traditionally used. 

In addition, electro-energy has been available in laparoscopy for more than 20 years. The same principles are applied in the vaginal approach to prevent risks associated with the use of energy. 

In addition to the use of the vessel-sealing device for hemostasis, I described the use of electrocautery to create a superficial relaxing incision in the mucosa of the distal posterior vagina. This incision is no more than 2–3 mm deep and does not disrupt the levator ani, much less the rectum.  I have not had any complications ­associated with the use of this relaxing incision.  

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES” TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

Suggestions to boost safety
The patient positioning for minimally invasive procedures demonstrated in Dr. Advincula’s video has worked well for me. However, I would like to offer a few additional maneuvers to increase safety:

• Preoperatively, tell the patient that she will have received intravenous (IV) medication to relieve anxiety before entering the operating room. Explain that she will be placed in stirrups and covered.
• Once the patient is in stirrups, ask if she is comfortable before she receives general anesthesia. This helps to identify pressure points on the lower back.
• Undo the snaps/buttons at the top of the hospital gown and remove the gown from beneath the shoulders to help prevent pressure points on the shoulder girdle.
• Before wrapping and tucking the arms, cut off any plastic clips that control flow from the IV line at the wrist or forearm; the clips are not needed and could potentially cause pressure point injury. Also place a piece of gauze between the arm and IV connections to prevent pressure point injury.
• Prevent calf pressure by placing the heel against the back of the stirrup foot-piece.

Ray Wertheim, MD
Fairfax, Virginia

Share your thoughts on these letters or on another article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“TRANSFER TO THE HOSPITAL FOR WOMEN PLANNING A HOME BIRTH: A HIGH-RISK OBSTETRICS PROBLEM”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2014)

Uterus ruptures at home
A woman (G4P3) had undergone two cesarean deliveries followed by successful vaginal birth after cesarean (VBAC) in hospital. During her second trimester, the patient decided, against the advice of her ObGyn, to have a home delivery. Her midwife was present when, after several hours, the mother felt a sudden sharp pain. When the midwife detected fetal heart-rate tones of 60–70 bpm, she called 911. The patient was transported to the labor and delivery (L&D) unit where I was the in-house ObGyn on call for unattached patients.

In triage, the baby’s heart rate was in the 60-bpm range. I found no presenting part of the fetus on vaginal examination; the patient had a surgical abdomen on palpation. She was immediately taken for an emergency cesarean delivery. We found the baby halfway out of a uterine rupture. The placenta was still partially attached to the fundus. 

The baby’s blood gases were too low to register on the machine. She was resuscitated, but still had no suck or gag reflex when discharged from the neonatal intensive care unit (NICU), with minimal brainstem function.

The mother didn’t require blood products because the rupture was barely bleeding. The uterine rupture occurred over the entire scar area from previous cesarean deliveries. The mother was in our hospital for a total of 14 minutes before delivery occurred.

I have no collaborative agreement with any midwife for accepting their failed home birth attempts. 

Kevin Fulford, MD
San Diego, California

A perfect candidate for home birth?
In my last call as a resident, a patient arrived at L&D after arrest of labor at 5 cm for many hours. The patient was a G1P0 at term with twins and the presenting twin was in a known breech presentation. The patient quickly agreed to a cesarean delivery and has two healthy babies. 

I will never forget the patient’s lay midwife telling me that the mother was the “perfect candidate for a home birth.” She seemed so disappointed by the patient’s decision to head to the hospital. It made for a memorable last night as a resident!

Erinn Hoekstra, MD
Grand Rapids, Michigan

Why women choose out-of-hospital birth
As a Board-Certified ObGyn who attends women at home, at a birthing center, and in hospital, I find this article lacking in two ways: why women choose out-of-hospital birth and why maternal outcomes at home are never discussed. 

Women choose out-of-hospital birth because they are refused meaningful decision making in their labor and birth processes. They are refused VBACs, vaginal delivery of breech presentations, food and drink, and are forced to accept continuous electronic fetal monitoring (EFM), to name but a few. They also choose to stay away from the hospital because of the cascade of unscientific interventions that lead to unnecessary cesarean deliveries.

Noted in the article are neonatal outcomes, but not maternal outcomes, which are universally better outside the hospital. Fewer than 2% of women birth at home. Therefore, they can’t be responsible for the skyrocketing maternal mortality rate, the ever-increasing induction and cesarean delivery rates, and attendant accretas, etc. We have reached the point that Semmelweiss noted in Vienna in the 1800s: women who deliver outside the hospital are less likely to die than those who deliver inside.

So much hand-wringing over the few who stay away from the hospital rather than reforming the practice of obstetrics to make it safer for the majority of women who go to hospital.

Katharine Morrison, MD
The Birthing Center of Buffalo
Buffalo, New York

Dr. Barbieri responds
I appreciate the perspectives and case histories provided by Drs. Fulford, and Hoekstra. As these case reports indicate, home birth can be dangerous for both the newborn and mother. Drs. Fulford, Hoekstra, and I agree with the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) that pregnant women should deliver at certified birth centers or hospital-based obstetrics units in order to optimize outcomes for newborns and mothers. 

Dr. Morrison supports the ACOG and AAP conclusion that women have a right to exercise their autonomy and choose a planned home birth. I know that all clinicians are deeply dedicated to continually advancing the quality of care we provide to pregnant women, regardless of their perspectives on home birth.

“TRANSFORMING VAGINAL HYSTERECTOMY: 7 SOLUTIONS TO THE MOST DAUNTING CHALLENGES”
ROSANNE M. KHO, MD (SURGICAL TECHNIQUES; AUGUST 2014)

Additional tips for vaginal hysterectomy
I concur with Dr. Kho’s recommendations regarding vaginal hysterectomy. Having been in practice for 32 years, I have performed more than 2,000 vaginal hysterectomies and it continues to be my preferred method.

As a volunteer faculty member in the benign gynecology division of a medical school, I am dismayed at the lack of adequate training gynecologists have received upon graduation—admittedly, some because they choose something else or will perform only laparoscopic surgery.

Here are a few tips that I use to improve my success:

• place indigo carmine in the bladder before starting the case
• inject the vaginal mucosa with vasopressin in saline solution to decrease bleeding
• wear a headlamp like vascular surgeons use
• use an electrical sealer (Ligasure Vessel Sealing Generator, Covidien) to reduce knot tying.

I developed what I call a “baby-lap” that is one-third the size of a regular laparotomy that can be used to push the bowel and other organs away to gain better visualization while removing the ovaries and performing a McCall culdoplasty.

I tell residents not to miss these vaginal hysterectomy cases instead of attending lectures, but sometimes it falls in deaf ears. I consider it my moral obligation to pass on this expertise to young gynecologists for the betterment of future generations.

Richard Nuila-Crouse, MD
Houston Texas

Why does vaginal hysterectomy have to be so complicated?
Adding more technology to a formerly straightforward procedure causes additional problems for most vaginal hysterectomies. I am a proponent of the “KISS” (Keep It Simple, Stupid) philosophy!

I don’t agree with several points that Dr. Kho presents in her article and video:

• The Magrina-Bookwalter Retractor as used decreases exposure. On the video, Dr. Kho could not even get her small fingers into the vagina.
• Positioning the surgeon in the upright position (not sitting) makes it much easier to perform the procedure, and aids the assistants.
• Use a headlamp for a better lighting source. A properly fixed overhead lamp can also provide excellent light to the operative field.
• In well over 550 vaginal hysterectomies, I never had to enlarge the introitus with an incision. What were Dr. Kho’s complications by doing so? Has she ever entered the rectal area with this incision?
• In the video, Dr. Kho used a cautery, something that used to be unheard of due to its associated complications. What complications has she had by using it?

New technology has not improved the technique of performing a vaginal hysterectomy. Why make this procedure so complicated when, in reality, it is a simple, straightforward surgical procedure that can usually be performed in less than 60 minutes.

Rudi Ansbacher, MD, MS
Professor Emeritus of Obstetrics and Gynecology
University of Michigan Health System
Ann Arbor, Michigan

Dr. Kho responds
I appreciate the comments of Dr. ­Nuila-Crouse and Dr. Ansbacher.

The “baby-lap” that Dr. Nuila-Crouse describes sounds very similar to the vaginal packing I use, manufactured by Dukal Corporation. It is an 8-ply, 4” x 46” packing that greatly facilitates the case, particularly with the adnexectomy and placement of the sutures on the uterosacral ligaments to support the vaginal apex.

As I mentioned in the article, it is time that we update our techniques and incorporate available surgical innovation and devices to facilitate the vaginal procedure and prevent its continued decline. The use of the Magrina-Bookwalter vaginal retractor system eliminates the need for two bedside assistants. The self-retracting blades are also significantly narrower than the weighted speculum and deaver retractors traditionally used. 

In addition, electro-energy has been available in laparoscopy for more than 20 years. The same principles are applied in the vaginal approach to prevent risks associated with the use of energy. 

In addition to the use of the vessel-sealing device for hemostasis, I described the use of electrocautery to create a superficial relaxing incision in the mucosa of the distal posterior vagina. This incision is no more than 2–3 mm deep and does not disrupt the levator ani, much less the rectum.  I have not had any complications ­associated with the use of this relaxing incision.  

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES” TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

Suggestions to boost safety
The patient positioning for minimally invasive procedures demonstrated in Dr. Advincula’s video has worked well for me. However, I would like to offer a few additional maneuvers to increase safety:

• Preoperatively, tell the patient that she will have received intravenous (IV) medication to relieve anxiety before entering the operating room. Explain that she will be placed in stirrups and covered.
• Once the patient is in stirrups, ask if she is comfortable before she receives general anesthesia. This helps to identify pressure points on the lower back.
• Undo the snaps/buttons at the top of the hospital gown and remove the gown from beneath the shoulders to help prevent pressure points on the shoulder girdle.
• Before wrapping and tucking the arms, cut off any plastic clips that control flow from the IV line at the wrist or forearm; the clips are not needed and could potentially cause pressure point injury. Also place a piece of gauze between the arm and IV connections to prevent pressure point injury.
• Prevent calf pressure by placing the heel against the back of the stirrup foot-piece.

Ray Wertheim, MD
Fairfax, Virginia

Share your thoughts on these letters or on another article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“TRANSFER TO THE HOSPITAL FOR WOMEN PLANNING A HOME BIRTH: A HIGH-RISK OBSTETRICS PROBLEM”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2014)

Uterus ruptures at home
A woman (G4P3) had undergone two cesarean deliveries followed by successful vaginal birth after cesarean (VBAC) in hospital. During her second trimester, the patient decided, against the advice of her ObGyn, to have a home delivery. Her midwife was present when, after several hours, the mother felt a sudden sharp pain. When the midwife detected fetal heart-rate tones of 60–70 bpm, she called 911. The patient was transported to the labor and delivery (L&D) unit where I was the in-house ObGyn on call for unattached patients.

In triage, the baby’s heart rate was in the 60-bpm range. I found no presenting part of the fetus on vaginal examination; the patient had a surgical abdomen on palpation. She was immediately taken for an emergency cesarean delivery. We found the baby halfway out of a uterine rupture. The placenta was still partially attached to the fundus. 

The baby’s blood gases were too low to register on the machine. She was resuscitated, but still had no suck or gag reflex when discharged from the neonatal intensive care unit (NICU), with minimal brainstem function.

The mother didn’t require blood products because the rupture was barely bleeding. The uterine rupture occurred over the entire scar area from previous cesarean deliveries. The mother was in our hospital for a total of 14 minutes before delivery occurred.

I have no collaborative agreement with any midwife for accepting their failed home birth attempts. 

Kevin Fulford, MD
San Diego, California

A perfect candidate for home birth?
In my last call as a resident, a patient arrived at L&D after arrest of labor at 5 cm for many hours. The patient was a G1P0 at term with twins and the presenting twin was in a known breech presentation. The patient quickly agreed to a cesarean delivery and has two healthy babies. 

I will never forget the patient’s lay midwife telling me that the mother was the “perfect candidate for a home birth.” She seemed so disappointed by the patient’s decision to head to the hospital. It made for a memorable last night as a resident!

Erinn Hoekstra, MD
Grand Rapids, Michigan

Why women choose out-of-hospital birth
As a Board-Certified ObGyn who attends women at home, at a birthing center, and in hospital, I find this article lacking in two ways: why women choose out-of-hospital birth and why maternal outcomes at home are never discussed. 

Women choose out-of-hospital birth because they are refused meaningful decision making in their labor and birth processes. They are refused VBACs, vaginal delivery of breech presentations, food and drink, and are forced to accept continuous electronic fetal monitoring (EFM), to name but a few. They also choose to stay away from the hospital because of the cascade of unscientific interventions that lead to unnecessary cesarean deliveries.

Noted in the article are neonatal outcomes, but not maternal outcomes, which are universally better outside the hospital. Fewer than 2% of women birth at home. Therefore, they can’t be responsible for the skyrocketing maternal mortality rate, the ever-increasing induction and cesarean delivery rates, and attendant accretas, etc. We have reached the point that Semmelweiss noted in Vienna in the 1800s: women who deliver outside the hospital are less likely to die than those who deliver inside.

So much hand-wringing over the few who stay away from the hospital rather than reforming the practice of obstetrics to make it safer for the majority of women who go to hospital.

Katharine Morrison, MD
The Birthing Center of Buffalo
Buffalo, New York

Dr. Barbieri responds
I appreciate the perspectives and case histories provided by Drs. Fulford, and Hoekstra. As these case reports indicate, home birth can be dangerous for both the newborn and mother. Drs. Fulford, Hoekstra, and I agree with the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) that pregnant women should deliver at certified birth centers or hospital-based obstetrics units in order to optimize outcomes for newborns and mothers. 

Dr. Morrison supports the ACOG and AAP conclusion that women have a right to exercise their autonomy and choose a planned home birth. I know that all clinicians are deeply dedicated to continually advancing the quality of care we provide to pregnant women, regardless of their perspectives on home birth.

“TRANSFORMING VAGINAL HYSTERECTOMY: 7 SOLUTIONS TO THE MOST DAUNTING CHALLENGES”
ROSANNE M. KHO, MD (SURGICAL TECHNIQUES; AUGUST 2014)

Additional tips for vaginal hysterectomy
I concur with Dr. Kho’s recommendations regarding vaginal hysterectomy. Having been in practice for 32 years, I have performed more than 2,000 vaginal hysterectomies and it continues to be my preferred method.

As a volunteer faculty member in the benign gynecology division of a medical school, I am dismayed at the lack of adequate training gynecologists have received upon graduation—admittedly, some because they choose something else or will perform only laparoscopic surgery.

Here are a few tips that I use to improve my success:

• place indigo carmine in the bladder before starting the case
• inject the vaginal mucosa with vasopressin in saline solution to decrease bleeding
• wear a headlamp like vascular surgeons use
• use an electrical sealer (Ligasure Vessel Sealing Generator, Covidien) to reduce knot tying.

I developed what I call a “baby-lap” that is one-third the size of a regular laparotomy that can be used to push the bowel and other organs away to gain better visualization while removing the ovaries and performing a McCall culdoplasty.

I tell residents not to miss these vaginal hysterectomy cases instead of attending lectures, but sometimes it falls in deaf ears. I consider it my moral obligation to pass on this expertise to young gynecologists for the betterment of future generations.

Richard Nuila-Crouse, MD
Houston Texas

Why does vaginal hysterectomy have to be so complicated?
Adding more technology to a formerly straightforward procedure causes additional problems for most vaginal hysterectomies. I am a proponent of the “KISS” (Keep It Simple, Stupid) philosophy!

I don’t agree with several points that Dr. Kho presents in her article and video:

• The Magrina-Bookwalter Retractor as used decreases exposure. On the video, Dr. Kho could not even get her small fingers into the vagina.
• Positioning the surgeon in the upright position (not sitting) makes it much easier to perform the procedure, and aids the assistants.
• Use a headlamp for a better lighting source. A properly fixed overhead lamp can also provide excellent light to the operative field.
• In well over 550 vaginal hysterectomies, I never had to enlarge the introitus with an incision. What were Dr. Kho’s complications by doing so? Has she ever entered the rectal area with this incision?
• In the video, Dr. Kho used a cautery, something that used to be unheard of due to its associated complications. What complications has she had by using it?

New technology has not improved the technique of performing a vaginal hysterectomy. Why make this procedure so complicated when, in reality, it is a simple, straightforward surgical procedure that can usually be performed in less than 60 minutes.

Rudi Ansbacher, MD, MS
Professor Emeritus of Obstetrics and Gynecology
University of Michigan Health System
Ann Arbor, Michigan

Dr. Kho responds
I appreciate the comments of Dr. ­Nuila-Crouse and Dr. Ansbacher.

The “baby-lap” that Dr. Nuila-Crouse describes sounds very similar to the vaginal packing I use, manufactured by Dukal Corporation. It is an 8-ply, 4” x 46” packing that greatly facilitates the case, particularly with the adnexectomy and placement of the sutures on the uterosacral ligaments to support the vaginal apex.

As I mentioned in the article, it is time that we update our techniques and incorporate available surgical innovation and devices to facilitate the vaginal procedure and prevent its continued decline. The use of the Magrina-Bookwalter vaginal retractor system eliminates the need for two bedside assistants. The self-retracting blades are also significantly narrower than the weighted speculum and deaver retractors traditionally used. 

In addition, electro-energy has been available in laparoscopy for more than 20 years. The same principles are applied in the vaginal approach to prevent risks associated with the use of energy. 

In addition to the use of the vessel-sealing device for hemostasis, I described the use of electrocautery to create a superficial relaxing incision in the mucosa of the distal posterior vagina. This incision is no more than 2–3 mm deep and does not disrupt the levator ani, much less the rectum.  I have not had any complications ­associated with the use of this relaxing incision.  

“PREVENTING POSTOPERATIVE NEUROPATHIES: PATIENT POSITIONING FOR MINIMALLY INVASIVE PROCEDURES” TIFFANY JACKSON, MD; BICH-VAN TRAN, MD; ARNOLD ADVINCULA, MD; KAREN WIERCINSKI, RN, BSN; JULIO LOPEZ (VIDEO; SEPTEMBER 2014)

Suggestions to boost safety
The patient positioning for minimally invasive procedures demonstrated in Dr. Advincula’s video has worked well for me. However, I would like to offer a few additional maneuvers to increase safety:

• Preoperatively, tell the patient that she will have received intravenous (IV) medication to relieve anxiety before entering the operating room. Explain that she will be placed in stirrups and covered.
• Once the patient is in stirrups, ask if she is comfortable before she receives general anesthesia. This helps to identify pressure points on the lower back.
• Undo the snaps/buttons at the top of the hospital gown and remove the gown from beneath the shoulders to help prevent pressure points on the shoulder girdle.
• Before wrapping and tucking the arms, cut off any plastic clips that control flow from the IV line at the wrist or forearm; the clips are not needed and could potentially cause pressure point injury. Also place a piece of gauze between the arm and IV connections to prevent pressure point injury.
• Prevent calf pressure by placing the heel against the back of the stirrup foot-piece.

Ray Wertheim, MD
Fairfax, Virginia

Share your thoughts on these letters or on another article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.