OBG Management

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected]
Please include the city and state in which you practice.

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected]
Please include the city and state in which you practice.

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: [email protected]
Please include the city and state in which you practice.

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

Click here to download the PDF.

As Obstetrician-Gynecologists, we are charged with caring for women through every stage of their lives. From puberty to reproduction to menopause and beyond, we ensure that everything we do for our patients is in their short- and long-term best medical interests. We must continuously assess their risk factors in order to make medical and lifestyle recommendations that are most appropriately suited to each individual woman's need. One area of risk assessment often overlooked in our female patients is hereditary and familial cancer risk. The following is my journey of integrating hereditary cancer risk assessment (HCRA) into my everyday practice, and understanding it as fundamental to standard of care.

Click here to download the PDF.

As Obstetrician-Gynecologists, we are charged with caring for women through every stage of their lives. From puberty to reproduction to menopause and beyond, we ensure that everything we do for our patients is in their short- and long-term best medical interests. We must continuously assess their risk factors in order to make medical and lifestyle recommendations that are most appropriately suited to each individual woman's need. One area of risk assessment often overlooked in our female patients is hereditary and familial cancer risk. The following is my journey of integrating hereditary cancer risk assessment (HCRA) into my everyday practice, and understanding it as fundamental to standard of care.

Click here to download the PDF.

As Obstetrician-Gynecologists, we are charged with caring for women through every stage of their lives. From puberty to reproduction to menopause and beyond, we ensure that everything we do for our patients is in their short- and long-term best medical interests. We must continuously assess their risk factors in order to make medical and lifestyle recommendations that are most appropriately suited to each individual woman's need. One area of risk assessment often overlooked in our female patients is hereditary and familial cancer risk. The following is my journey of integrating hereditary cancer risk assessment (HCRA) into my everyday practice, and understanding it as fundamental to standard of care.

CASE: NULLIPAROUS WOMAN WITH A SHORT CERVIX
Your ultrasound technician telephones to report that your 32-year-old nulliparous patient, who is currently at 20 weeks’ gestation, was incidentally found to have a short cervix (18 mm) at the time of her routine fetal anatomy survey.

How do you proceed? And how do you counsel the patient? What interventions might reduce the risk of preterm birth (PTB)? Would your recommendations change if she had a history of PTB or was carrying twins?

Preterm birth, defined as delivery prior to 37 weeks’ gestation, is the leading cause of neonatal morbidity and mortality in the United States. The rate of PTB peaked at 12.8% in 2006 and has slowly declined since but remains unacceptably high at 11.5%.¹ Most PTBs are spontaneous, arising from the onset of labor or from preterm premature rupture of membranes. Regrettably, tocolytics remain largely ­ineffective once the process of preterm parturition has begun.

Ideally, women at highest risk for PTB could be identified so that additional screening and interventions could be initiated. Few prognostic tests are available to predict which women will deliver preterm. Generally, the greatest risk factor for spontaneous PTB is a history of spontaneous PTB.^2,3 However, women with such a history account for only 10% of all births before 34 weeks’ gestation.

The appearance and length of the cervix during the second trimester appears to be an even better predictor of spontaneous PTB than history alone (FIGURE 1).^4,5 For example, in one study of unselected pregnant women at 22 to 24 weeks’ gestation, only 1.7% had a cervical length less than 15 mm, but they accounted for 58% of births before 32 weeks.⁶ The shorter the cervix, the greater the risk of spontaneous PTB.⁷ The presence of a short cervix is even more ominous in a woman with a history of spontaneous PTB.⁸

Optimal pregnancy management after detection of a short cervix remains somewhat unclear and varies, based on the rest of the patient’s clinical picture and obstetric history.

In this article, I address 8 critical questions about diagnosis and management of the short cervix in the second trimester and offer evidence-based answers for clinical practice.

1. How is a short cervix defined?
A cervical length below the 10th centile for gestational age is considered “short.” At 18 to 24 weeks’ gestation, the 10th centile corresponds to a cervical length of less than 25 mm.⁹

The cervix undergoes physiologic shortening that begins at 28 to 30 weeks of gestation. At 32 weeks, the 50th centile for cervical length is 25 mm. Therefore, cervical-length measurements that appear moderately short between 28 and 32 weeks and beyond are of limited clinical utility, and the clinician should incorporate gestational age into prematurity risk assessment.⁷

2. Who should be screened?
The question of whether universal cervical-length assessment should be performed is controversial. Several decision analyses in recent years suggest that universal sonographic screening for a short cervix is cost-effective.^10,11 Overall, however, the effectiveness of universal cervical-length screening remains clinically understudied, and it is difficult to draw conclusions from decision analyses. Moreover, there is considerable concern about resources and feasibility of implementing universal vaginal cervical-length assessment, as well as significant disagreement about the accuracy of transabdominal cervical-length assessment in the detection of a short cervix.

Transabdominal ultrasound may overestimate cervical length by as much as 10 to 15 mm. One recent study demonstrated that, using a transabdominal cutoff of 30 mm, the sensitivity of detecting a transvaginal cervical length of less than 20 mm was 90%; if the cutoff was increased to 35 mm, sensitivity increased to 100%.¹²

A collaborative practice guideline on obstetric ultrasound from the American College of Radiology, American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and the Society of Radiologists in Ultrasound recommends that the maternal cervix be examined “as clinically appropriate when technically feasible” during a standard second- or third-trimester ultrasound examination (FIGURE 2).¹³ The guideline also states that transvaginal or transperineal ultrasound may be considered if the cervix appears shortened or cannot be adequately visualized during the transabdominal ultrasound. However, no specific protocols are suggested.

Given the uncertainty, it is recommended that each practice or ultrasound unit adopt a standard protocol for cervical-length assessment during pregnancy. This protocol can entail either routine abdominal or vaginal assessment of the cervix, or a combination of abdominal and vaginal assessment. Clinical risk factors can be used to help stratify low-risk women when abdominal cervical-length assessment is the initial approach to evaluation.

In my practice, all women undergo ­cervical-length assessment at the time of the routine anatomy survey (18–22 weeks). Those who are at low risk for PTB are screened initially with transabdominal ultrasound, and a transvaginal examination is performed if the cervix cannot be seen or appears to be less than 30 mm in length.

Women with a history of spontaneous PTB undergo screening by transvaginal cervical-length assessment. Typically, the first measurement is obtained at the time of the fetal anatomic survey (18–22 weeks), when the lower uterine segment is sufficiently developed to accurately measure the cervix. We perform serial cervical-length assessment every 1 or 2 weeks until 28 weeks’ gestation in women with a prior early spontaneous PTB (<34 weeks), those with a history of recurrent PTB, and those who have an initial short cervix. Serial monitoring has been shown to increase the prediction of spontaneous PTB in high-risk women.¹⁴

See the algorithm presented in (FIGURE 3) for the screening and treatment of women with singleton gestations.

3. How do I counsel patients about the risk of prematurity?
The risk of spontaneous PTB varies with the gestational age that the short cervix is detected and with the degree of cervical shortening. The earlier in the pregnancy the cervix is found to be short, the higher the risk for spontaneous PTB. For example, results of one large multicenter study of almost 3,000 unselected women pregnant with a singleton gestation across the United States showed that a cervical length of 25 mm was associated with a 15% to 20% incidence of PTB when detected at 28 weeks’ gestation; the incidence rose to 30% to 35% if the short cervix was detected at 20 weeks.⁹ In this cohort, 84% of women had no history of PTB.

A short cervix and a prior PTB (particularly a very early prior PTB) are two major risk factors for PTB. Together, they significantly increase the risk of an early delivery over individual or single factors alone. Among women who have had a prior PTB and who now have a cervical length of less than 25 mm, the risk of recurrent PTB is 35% to 40%. In contrast, women with a prior PTB and a normal cervical length have a significantly lower risk of recurrence—around 10%.¹⁵

If the physical examination is concerning for cervical dilation or prolapsing membranes, women should be counseled about the poor prognosis for the pregnancy, particularly when these findings are detected at a previable or periviable gestational age, regardless of their history of PTB. In these circumstances, in the absence of labor or intra-amniotic infection, a “rescue” cervical cerclage may be considered as a last resort (see page 34 for more on cerclage).

4. What evaluation or monitoring is needed once a short cervix is identified?
Women found to have a short cervix should be evaluated for the presence of preterm labor and intra-amniotic infection. This evaluation may include a sterile speculum examination or digital cervical examination, or both, as well as screening for genitourinary tract infection. Other testing may include a complete blood count with a white blood cell differential and external tocometry with or without fetal heart rate monitoring (based on the gestational age, as appropriate). 

For some women with a short cervix, intra-amniotic infection may be a contributing factor (or it may develop if there are exposed membranes in the vagina). The presence of intra-amniotic infection precludes further expectant management of the pregnancy because of the risk of maternal infectious morbidity, including sepsis.

Women who have intra-amniotic infection are not candidates for any intervention such as cerclage or progesterone supplementation.

If the patient is at or beyond the point of fetal viability at the time her short cervix is detected, consider external fetal heart rate monitoring.

Antenatal corticosteroids can be administered, as appropriate, depending on the perceived risk of delivery.

5. Should I place a cerclage?
Numerous studies have examined the efficacy of ultrasound-indicated cerclage, a surgical procedure to stitch the cervix closed once a short cervix has been detected.

In general, placement of a cervical cerclage is not offered past the point of fetal viability, which is generally in the range of 23 to 25 weeks’ gestation, depending on local institutional and neonatal intensive care unit policies. Confirmed or suspected chorioamnionitis is also a contraindication to cerclage placement.

Among women without a history of PTB who are found to have a short cervix, existing data do not suggest a benefit for cerclage, although vaginal progesterone appears to be a reasonable option (see page 36).^16,17

As for women with a history of PTB, Owen and colleagues studied 302 patients with a cervical length less than 25 mm and a history of spontaneous PTB before 34 weeks.¹⁸ The women were randomly assigned to ultrasound-indicated cerclage or “usual care,” which consisted of recommendations of pelvic rest, physical activity restriction, and education about the symptoms of preterm labor. Otherwise, management was directed by clinical practice at each center. All women treated with cerclage had a reduced risk of previable PTB (<24 weeks’ gestation), and those who had the shortest cervical length (<15 mm) also had a lower risk of delivery before 35 weeks.

The degree of cervical shortening that has “qualified” women for study enrollment has varied between studies, with upper limits ranging from 15 to 25 mm. Berghella and colleagues performed a patient-level meta-analysis to determine whether efficacy of the cerclage varied by cervical length at the time of placement.⁸ They examined 552 women with singleton gestations from four randomized controlled trials that included 208 women with a short cervix and a history of spontaneous PTB. They found a significant reduction in the rate of preterm delivery before 35 weeks’ gestation among women with singleton pregnancies, a short cervix, and a history of spontaneous PTB; the reduction did not vary by the degree of cervical shortening. However, there was no significant reduction in the rate of PTB among the subset of women without a history of spontaneous PTB.

Berghella and colleagues estimated that, if a cervical cerclage were offered to the 8% of women with a prior spontaneous PTB and a cervical length of less than 25 mm, more than 6,500 newborns would be saved each year from perinatal death associated with prematurity.⁸

The placement of a “rescue” cerclage in the setting of cervical dilation with or without prolapsing membranes is associated with high rates of maternal and neonatal morbidity, regardless of the patient’s obstetric history. However, cerclage placement in this setting may be associated with better outcomes than expectant management with bed rest alone.¹⁹ Patients should be carefully counseled about this procedure, including the risk of infection and the possibility that pregnancy may be prolonged only from a previable to a periviable gestational age. Decisions as to whether a patient is a candidate for rescue cerclage should be made in consultation with a maternal-fetal medicine specialist.²⁰

6. Is a cervical pessary beneficial?
The pessary is another “mechanical” treatment similar to cerclage, and it may be helpful in reducing the incidence of PTB among women with a short cervix. In the largest study of this approach, 16,000 primarily low-risk women with singleton gestations were screened for a short cervix. Of these, 385 women with a cervical length of less than 25 mm were randomly assigned to undergo Arabin pessary placement or expectant management.²¹

Among those who received the pessary, the odds ratio (OR) for PTB before 34 weeks was significantly reduced (OR, 0.18; 95% confidence interval [CI], 0.08–0.37), and the OR for adverse composite neonatal outcome also was significantly reduced (OR, 0.14; 95% CI, 0.04–0.39).²¹

The Arabin pessary is not currently approved by the US Food and Drug Administration for this indication in the United States, nor is it available for insertion outside of research studies. Other ring-shaped pessaries are available in the United States, but their use in the setting of a short cervix is considered experimental and off-label. Additional studies of this promising intervention are currently under way.

7. Who is a candidate for supplemental progesterone?
Progesterone is a naturally occurring hormone essential to the maintenance of pregnancy. It has an overall quiescent effect on the myometrium, is known to have anti-inflammatory properties, and inhibits cervical ripening.²² It has been studied in a number of different formulations and doses.

Vaginal progesterone supplementation has been shown to reduce the risk of PTB among women with a shortened cervix regardless of their pregnancy history.^16,17,23,24 In the largest trials of unselected general obstetrics populations (including women with and without a history of PTB), use of vaginal progesterone among women with a short cervix reduced the rates of very early spontaneous PTB (<28 and <32 weeks’ gestation) by 40% to 50%.^16,17 As expected, progesterone also was associated with a significant reduction in the rates of respiratory distress syndrome and composite neonatal morbidity.

Intramuscular (IM) progesterone supplementation has been shown to reduce the rate of recurrent PTB among women with a history of spontaneous PTB. When caring for a woman with a history of PTB who is found to have a short cervix, IM progesterone should be offered if the woman is not already taking it. IM progesterone has not been proven effective among nulliparous women who are incidentally found to have a short cervix; it should not be offered in this situation.²⁵

8. Should the care of women carrying twins or triplets be managed differently?
Yes. Although women with multiple gestations are at higher risk for PTB than women carrying a singleton fetus, no interventions have proven to be effective in this population. Many studies have been limited to twin gestations as a group, with an inability to perform subgroup analyses or enroll women who also have a short cervix, due to sample size and power issues.

Progesterone in multiple gestations
Although several formulations of progesterone—including IM 17-alpha hydroxyprogesterone caproate, micronized progesterone, and progesterone suppositories—have been studied, no randomized trial data have demonstrated a reduction in PTB or neonatal morbidity.^26–29 Individual patient-level data from a meta-analysis of vaginal progesterone in the setting of multiple gestations with a short cervical length suggest trends toward a reduced rate of PTB before 33 weeks’ gestation (relative risk [RR], 0.70; 95% CI, 0.34–1.44) and lower composite neonatal morbidity and mortality (RR, 0.56; 95% CI, 0.30–0.97).³⁰

Mechanical strategies in multiple gestations
No randomized data suggest that a pessary is effective in multiple gestations. In one study of 813 multiple gestations in the Netherlands, women were randomly assigned—regardless of cervical length—to receive a pessary at 16 to 20 weeks versus standard care; no difference in adverse perinatal outcomes was detected between groups.³¹

As for cerclage, although data are limited, some studies suggest that placement of a cerclage in twin gestations with cervical shortening may increase the rate of PTB.³²

Bottom line for multiples
Although women carrying multiple gestations are at higher risk for PTB, data are extremely limited. At present, data do not support routine use of cerclage for a short cervix—and some suggest possible harm. Vaginal progesterone or placement of a pessary may be of benefit but should be used with caution and with the understanding that data are sparse.

CASE RESOLVED
You counsel your nulliparous patient that she has an elevated risk of PTB, based on her cervical length of 18 mm at 20 weeks’ gestation, and evaluate her clinically for evidence of preterm labor. Apart from the short cervix, her examination is unremarkable. You offer her nightly vaginal progesterone suppositories and schedule a visit to reevaluate her cervix in 1 week. If cervical dilation or prolapsing membranes are noted before the age of fetal viability, you will consider placing a “rescue” cervical cerclage.

Had this patient experienced a prior PTB, you would first ensure that she is taking IM 17-alpha hydroxyprogesterone caproate. It also would be reasonable to place an ultrasound-indicated cerclage or begin vaginal progesterone suppositories. Although data are limited on concomitant use of IM and vaginal progesterone, some experts may consider it, on an experimental basis, for patients with a short cervix and a prior PTB.

If this patient were carrying a twin gestation, vaginal progesterone would still be a consideration, provided she is counseled about the limited evidence of its efficacy in this setting. Cerclage would not be appropriate, given the possible risk of harm.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected] Please include your name, city and state. Stay in touch! Your feedback is important to us!

CASE: NULLIPAROUS WOMAN WITH A SHORT CERVIX
Your ultrasound technician telephones to report that your 32-year-old nulliparous patient, who is currently at 20 weeks’ gestation, was incidentally found to have a short cervix (18 mm) at the time of her routine fetal anatomy survey.

How do you proceed? And how do you counsel the patient? What interventions might reduce the risk of preterm birth (PTB)? Would your recommendations change if she had a history of PTB or was carrying twins?

Preterm birth, defined as delivery prior to 37 weeks’ gestation, is the leading cause of neonatal morbidity and mortality in the United States. The rate of PTB peaked at 12.8% in 2006 and has slowly declined since but remains unacceptably high at 11.5%.¹ Most PTBs are spontaneous, arising from the onset of labor or from preterm premature rupture of membranes. Regrettably, tocolytics remain largely ­ineffective once the process of preterm parturition has begun.

Ideally, women at highest risk for PTB could be identified so that additional screening and interventions could be initiated. Few prognostic tests are available to predict which women will deliver preterm. Generally, the greatest risk factor for spontaneous PTB is a history of spontaneous PTB.^2,3 However, women with such a history account for only 10% of all births before 34 weeks’ gestation.

The appearance and length of the cervix during the second trimester appears to be an even better predictor of spontaneous PTB than history alone (FIGURE 1).^4,5 For example, in one study of unselected pregnant women at 22 to 24 weeks’ gestation, only 1.7% had a cervical length less than 15 mm, but they accounted for 58% of births before 32 weeks.⁶ The shorter the cervix, the greater the risk of spontaneous PTB.⁷ The presence of a short cervix is even more ominous in a woman with a history of spontaneous PTB.⁸

Optimal pregnancy management after detection of a short cervix remains somewhat unclear and varies, based on the rest of the patient’s clinical picture and obstetric history.

In this article, I address 8 critical questions about diagnosis and management of the short cervix in the second trimester and offer evidence-based answers for clinical practice.

1. How is a short cervix defined?
A cervical length below the 10th centile for gestational age is considered “short.” At 18 to 24 weeks’ gestation, the 10th centile corresponds to a cervical length of less than 25 mm.⁹

The cervix undergoes physiologic shortening that begins at 28 to 30 weeks of gestation. At 32 weeks, the 50th centile for cervical length is 25 mm. Therefore, cervical-length measurements that appear moderately short between 28 and 32 weeks and beyond are of limited clinical utility, and the clinician should incorporate gestational age into prematurity risk assessment.⁷

2. Who should be screened?
The question of whether universal cervical-length assessment should be performed is controversial. Several decision analyses in recent years suggest that universal sonographic screening for a short cervix is cost-effective.^10,11 Overall, however, the effectiveness of universal cervical-length screening remains clinically understudied, and it is difficult to draw conclusions from decision analyses. Moreover, there is considerable concern about resources and feasibility of implementing universal vaginal cervical-length assessment, as well as significant disagreement about the accuracy of transabdominal cervical-length assessment in the detection of a short cervix.

Transabdominal ultrasound may overestimate cervical length by as much as 10 to 15 mm. One recent study demonstrated that, using a transabdominal cutoff of 30 mm, the sensitivity of detecting a transvaginal cervical length of less than 20 mm was 90%; if the cutoff was increased to 35 mm, sensitivity increased to 100%.¹²

A collaborative practice guideline on obstetric ultrasound from the American College of Radiology, American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and the Society of Radiologists in Ultrasound recommends that the maternal cervix be examined “as clinically appropriate when technically feasible” during a standard second- or third-trimester ultrasound examination (FIGURE 2).¹³ The guideline also states that transvaginal or transperineal ultrasound may be considered if the cervix appears shortened or cannot be adequately visualized during the transabdominal ultrasound. However, no specific protocols are suggested.

Given the uncertainty, it is recommended that each practice or ultrasound unit adopt a standard protocol for cervical-length assessment during pregnancy. This protocol can entail either routine abdominal or vaginal assessment of the cervix, or a combination of abdominal and vaginal assessment. Clinical risk factors can be used to help stratify low-risk women when abdominal cervical-length assessment is the initial approach to evaluation.

In my practice, all women undergo ­cervical-length assessment at the time of the routine anatomy survey (18–22 weeks). Those who are at low risk for PTB are screened initially with transabdominal ultrasound, and a transvaginal examination is performed if the cervix cannot be seen or appears to be less than 30 mm in length.

Women with a history of spontaneous PTB undergo screening by transvaginal cervical-length assessment. Typically, the first measurement is obtained at the time of the fetal anatomic survey (18–22 weeks), when the lower uterine segment is sufficiently developed to accurately measure the cervix. We perform serial cervical-length assessment every 1 or 2 weeks until 28 weeks’ gestation in women with a prior early spontaneous PTB (<34 weeks), those with a history of recurrent PTB, and those who have an initial short cervix. Serial monitoring has been shown to increase the prediction of spontaneous PTB in high-risk women.¹⁴

See the algorithm presented in (FIGURE 3) for the screening and treatment of women with singleton gestations.

3. How do I counsel patients about the risk of prematurity?
The risk of spontaneous PTB varies with the gestational age that the short cervix is detected and with the degree of cervical shortening. The earlier in the pregnancy the cervix is found to be short, the higher the risk for spontaneous PTB. For example, results of one large multicenter study of almost 3,000 unselected women pregnant with a singleton gestation across the United States showed that a cervical length of 25 mm was associated with a 15% to 20% incidence of PTB when detected at 28 weeks’ gestation; the incidence rose to 30% to 35% if the short cervix was detected at 20 weeks.⁹ In this cohort, 84% of women had no history of PTB.

A short cervix and a prior PTB (particularly a very early prior PTB) are two major risk factors for PTB. Together, they significantly increase the risk of an early delivery over individual or single factors alone. Among women who have had a prior PTB and who now have a cervical length of less than 25 mm, the risk of recurrent PTB is 35% to 40%. In contrast, women with a prior PTB and a normal cervical length have a significantly lower risk of recurrence—around 10%.¹⁵

If the physical examination is concerning for cervical dilation or prolapsing membranes, women should be counseled about the poor prognosis for the pregnancy, particularly when these findings are detected at a previable or periviable gestational age, regardless of their history of PTB. In these circumstances, in the absence of labor or intra-amniotic infection, a “rescue” cervical cerclage may be considered as a last resort (see page 34 for more on cerclage).

4. What evaluation or monitoring is needed once a short cervix is identified?
Women found to have a short cervix should be evaluated for the presence of preterm labor and intra-amniotic infection. This evaluation may include a sterile speculum examination or digital cervical examination, or both, as well as screening for genitourinary tract infection. Other testing may include a complete blood count with a white blood cell differential and external tocometry with or without fetal heart rate monitoring (based on the gestational age, as appropriate). 

For some women with a short cervix, intra-amniotic infection may be a contributing factor (or it may develop if there are exposed membranes in the vagina). The presence of intra-amniotic infection precludes further expectant management of the pregnancy because of the risk of maternal infectious morbidity, including sepsis.

Women who have intra-amniotic infection are not candidates for any intervention such as cerclage or progesterone supplementation.

If the patient is at or beyond the point of fetal viability at the time her short cervix is detected, consider external fetal heart rate monitoring.

Antenatal corticosteroids can be administered, as appropriate, depending on the perceived risk of delivery.

5. Should I place a cerclage?
Numerous studies have examined the efficacy of ultrasound-indicated cerclage, a surgical procedure to stitch the cervix closed once a short cervix has been detected.

In general, placement of a cervical cerclage is not offered past the point of fetal viability, which is generally in the range of 23 to 25 weeks’ gestation, depending on local institutional and neonatal intensive care unit policies. Confirmed or suspected chorioamnionitis is also a contraindication to cerclage placement.

Among women without a history of PTB who are found to have a short cervix, existing data do not suggest a benefit for cerclage, although vaginal progesterone appears to be a reasonable option (see page 36).^16,17

As for women with a history of PTB, Owen and colleagues studied 302 patients with a cervical length less than 25 mm and a history of spontaneous PTB before 34 weeks.¹⁸ The women were randomly assigned to ultrasound-indicated cerclage or “usual care,” which consisted of recommendations of pelvic rest, physical activity restriction, and education about the symptoms of preterm labor. Otherwise, management was directed by clinical practice at each center. All women treated with cerclage had a reduced risk of previable PTB (<24 weeks’ gestation), and those who had the shortest cervical length (<15 mm) also had a lower risk of delivery before 35 weeks.

The degree of cervical shortening that has “qualified” women for study enrollment has varied between studies, with upper limits ranging from 15 to 25 mm. Berghella and colleagues performed a patient-level meta-analysis to determine whether efficacy of the cerclage varied by cervical length at the time of placement.⁸ They examined 552 women with singleton gestations from four randomized controlled trials that included 208 women with a short cervix and a history of spontaneous PTB. They found a significant reduction in the rate of preterm delivery before 35 weeks’ gestation among women with singleton pregnancies, a short cervix, and a history of spontaneous PTB; the reduction did not vary by the degree of cervical shortening. However, there was no significant reduction in the rate of PTB among the subset of women without a history of spontaneous PTB.

Berghella and colleagues estimated that, if a cervical cerclage were offered to the 8% of women with a prior spontaneous PTB and a cervical length of less than 25 mm, more than 6,500 newborns would be saved each year from perinatal death associated with prematurity.⁸

The placement of a “rescue” cerclage in the setting of cervical dilation with or without prolapsing membranes is associated with high rates of maternal and neonatal morbidity, regardless of the patient’s obstetric history. However, cerclage placement in this setting may be associated with better outcomes than expectant management with bed rest alone.¹⁹ Patients should be carefully counseled about this procedure, including the risk of infection and the possibility that pregnancy may be prolonged only from a previable to a periviable gestational age. Decisions as to whether a patient is a candidate for rescue cerclage should be made in consultation with a maternal-fetal medicine specialist.²⁰

6. Is a cervical pessary beneficial?
The pessary is another “mechanical” treatment similar to cerclage, and it may be helpful in reducing the incidence of PTB among women with a short cervix. In the largest study of this approach, 16,000 primarily low-risk women with singleton gestations were screened for a short cervix. Of these, 385 women with a cervical length of less than 25 mm were randomly assigned to undergo Arabin pessary placement or expectant management.²¹

Among those who received the pessary, the odds ratio (OR) for PTB before 34 weeks was significantly reduced (OR, 0.18; 95% confidence interval [CI], 0.08–0.37), and the OR for adverse composite neonatal outcome also was significantly reduced (OR, 0.14; 95% CI, 0.04–0.39).²¹

The Arabin pessary is not currently approved by the US Food and Drug Administration for this indication in the United States, nor is it available for insertion outside of research studies. Other ring-shaped pessaries are available in the United States, but their use in the setting of a short cervix is considered experimental and off-label. Additional studies of this promising intervention are currently under way.

7. Who is a candidate for supplemental progesterone?
Progesterone is a naturally occurring hormone essential to the maintenance of pregnancy. It has an overall quiescent effect on the myometrium, is known to have anti-inflammatory properties, and inhibits cervical ripening.²² It has been studied in a number of different formulations and doses.

Vaginal progesterone supplementation has been shown to reduce the risk of PTB among women with a shortened cervix regardless of their pregnancy history.^16,17,23,24 In the largest trials of unselected general obstetrics populations (including women with and without a history of PTB), use of vaginal progesterone among women with a short cervix reduced the rates of very early spontaneous PTB (<28 and <32 weeks’ gestation) by 40% to 50%.^16,17 As expected, progesterone also was associated with a significant reduction in the rates of respiratory distress syndrome and composite neonatal morbidity.

Intramuscular (IM) progesterone supplementation has been shown to reduce the rate of recurrent PTB among women with a history of spontaneous PTB. When caring for a woman with a history of PTB who is found to have a short cervix, IM progesterone should be offered if the woman is not already taking it. IM progesterone has not been proven effective among nulliparous women who are incidentally found to have a short cervix; it should not be offered in this situation.²⁵

8. Should the care of women carrying twins or triplets be managed differently?
Yes. Although women with multiple gestations are at higher risk for PTB than women carrying a singleton fetus, no interventions have proven to be effective in this population. Many studies have been limited to twin gestations as a group, with an inability to perform subgroup analyses or enroll women who also have a short cervix, due to sample size and power issues.

Progesterone in multiple gestations
Although several formulations of progesterone—including IM 17-alpha hydroxyprogesterone caproate, micronized progesterone, and progesterone suppositories—have been studied, no randomized trial data have demonstrated a reduction in PTB or neonatal morbidity.^26–29 Individual patient-level data from a meta-analysis of vaginal progesterone in the setting of multiple gestations with a short cervical length suggest trends toward a reduced rate of PTB before 33 weeks’ gestation (relative risk [RR], 0.70; 95% CI, 0.34–1.44) and lower composite neonatal morbidity and mortality (RR, 0.56; 95% CI, 0.30–0.97).³⁰

Mechanical strategies in multiple gestations
No randomized data suggest that a pessary is effective in multiple gestations. In one study of 813 multiple gestations in the Netherlands, women were randomly assigned—regardless of cervical length—to receive a pessary at 16 to 20 weeks versus standard care; no difference in adverse perinatal outcomes was detected between groups.³¹

As for cerclage, although data are limited, some studies suggest that placement of a cerclage in twin gestations with cervical shortening may increase the rate of PTB.³²

Bottom line for multiples
Although women carrying multiple gestations are at higher risk for PTB, data are extremely limited. At present, data do not support routine use of cerclage for a short cervix—and some suggest possible harm. Vaginal progesterone or placement of a pessary may be of benefit but should be used with caution and with the understanding that data are sparse.

CASE RESOLVED
You counsel your nulliparous patient that she has an elevated risk of PTB, based on her cervical length of 18 mm at 20 weeks’ gestation, and evaluate her clinically for evidence of preterm labor. Apart from the short cervix, her examination is unremarkable. You offer her nightly vaginal progesterone suppositories and schedule a visit to reevaluate her cervix in 1 week. If cervical dilation or prolapsing membranes are noted before the age of fetal viability, you will consider placing a “rescue” cervical cerclage.

Had this patient experienced a prior PTB, you would first ensure that she is taking IM 17-alpha hydroxyprogesterone caproate. It also would be reasonable to place an ultrasound-indicated cerclage or begin vaginal progesterone suppositories. Although data are limited on concomitant use of IM and vaginal progesterone, some experts may consider it, on an experimental basis, for patients with a short cervix and a prior PTB.

If this patient were carrying a twin gestation, vaginal progesterone would still be a consideration, provided she is counseled about the limited evidence of its efficacy in this setting. Cerclage would not be appropriate, given the possible risk of harm.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected] Please include your name, city and state. Stay in touch! Your feedback is important to us!

CASE: NULLIPAROUS WOMAN WITH A SHORT CERVIX
Your ultrasound technician telephones to report that your 32-year-old nulliparous patient, who is currently at 20 weeks’ gestation, was incidentally found to have a short cervix (18 mm) at the time of her routine fetal anatomy survey.

How do you proceed? And how do you counsel the patient? What interventions might reduce the risk of preterm birth (PTB)? Would your recommendations change if she had a history of PTB or was carrying twins?

Preterm birth, defined as delivery prior to 37 weeks’ gestation, is the leading cause of neonatal morbidity and mortality in the United States. The rate of PTB peaked at 12.8% in 2006 and has slowly declined since but remains unacceptably high at 11.5%.¹ Most PTBs are spontaneous, arising from the onset of labor or from preterm premature rupture of membranes. Regrettably, tocolytics remain largely ­ineffective once the process of preterm parturition has begun.

Ideally, women at highest risk for PTB could be identified so that additional screening and interventions could be initiated. Few prognostic tests are available to predict which women will deliver preterm. Generally, the greatest risk factor for spontaneous PTB is a history of spontaneous PTB.^2,3 However, women with such a history account for only 10% of all births before 34 weeks’ gestation.

The appearance and length of the cervix during the second trimester appears to be an even better predictor of spontaneous PTB than history alone (FIGURE 1).^4,5 For example, in one study of unselected pregnant women at 22 to 24 weeks’ gestation, only 1.7% had a cervical length less than 15 mm, but they accounted for 58% of births before 32 weeks.⁶ The shorter the cervix, the greater the risk of spontaneous PTB.⁷ The presence of a short cervix is even more ominous in a woman with a history of spontaneous PTB.⁸

Optimal pregnancy management after detection of a short cervix remains somewhat unclear and varies, based on the rest of the patient’s clinical picture and obstetric history.

In this article, I address 8 critical questions about diagnosis and management of the short cervix in the second trimester and offer evidence-based answers for clinical practice.

1. How is a short cervix defined?
A cervical length below the 10th centile for gestational age is considered “short.” At 18 to 24 weeks’ gestation, the 10th centile corresponds to a cervical length of less than 25 mm.⁹

The cervix undergoes physiologic shortening that begins at 28 to 30 weeks of gestation. At 32 weeks, the 50th centile for cervical length is 25 mm. Therefore, cervical-length measurements that appear moderately short between 28 and 32 weeks and beyond are of limited clinical utility, and the clinician should incorporate gestational age into prematurity risk assessment.⁷

2. Who should be screened?
The question of whether universal cervical-length assessment should be performed is controversial. Several decision analyses in recent years suggest that universal sonographic screening for a short cervix is cost-effective.^10,11 Overall, however, the effectiveness of universal cervical-length screening remains clinically understudied, and it is difficult to draw conclusions from decision analyses. Moreover, there is considerable concern about resources and feasibility of implementing universal vaginal cervical-length assessment, as well as significant disagreement about the accuracy of transabdominal cervical-length assessment in the detection of a short cervix.

Transabdominal ultrasound may overestimate cervical length by as much as 10 to 15 mm. One recent study demonstrated that, using a transabdominal cutoff of 30 mm, the sensitivity of detecting a transvaginal cervical length of less than 20 mm was 90%; if the cutoff was increased to 35 mm, sensitivity increased to 100%.¹²

A collaborative practice guideline on obstetric ultrasound from the American College of Radiology, American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and the Society of Radiologists in Ultrasound recommends that the maternal cervix be examined “as clinically appropriate when technically feasible” during a standard second- or third-trimester ultrasound examination (FIGURE 2).¹³ The guideline also states that transvaginal or transperineal ultrasound may be considered if the cervix appears shortened or cannot be adequately visualized during the transabdominal ultrasound. However, no specific protocols are suggested.

Given the uncertainty, it is recommended that each practice or ultrasound unit adopt a standard protocol for cervical-length assessment during pregnancy. This protocol can entail either routine abdominal or vaginal assessment of the cervix, or a combination of abdominal and vaginal assessment. Clinical risk factors can be used to help stratify low-risk women when abdominal cervical-length assessment is the initial approach to evaluation.

In my practice, all women undergo ­cervical-length assessment at the time of the routine anatomy survey (18–22 weeks). Those who are at low risk for PTB are screened initially with transabdominal ultrasound, and a transvaginal examination is performed if the cervix cannot be seen or appears to be less than 30 mm in length.

Women with a history of spontaneous PTB undergo screening by transvaginal cervical-length assessment. Typically, the first measurement is obtained at the time of the fetal anatomic survey (18–22 weeks), when the lower uterine segment is sufficiently developed to accurately measure the cervix. We perform serial cervical-length assessment every 1 or 2 weeks until 28 weeks’ gestation in women with a prior early spontaneous PTB (<34 weeks), those with a history of recurrent PTB, and those who have an initial short cervix. Serial monitoring has been shown to increase the prediction of spontaneous PTB in high-risk women.¹⁴

See the algorithm presented in (FIGURE 3) for the screening and treatment of women with singleton gestations.

3. How do I counsel patients about the risk of prematurity?
The risk of spontaneous PTB varies with the gestational age that the short cervix is detected and with the degree of cervical shortening. The earlier in the pregnancy the cervix is found to be short, the higher the risk for spontaneous PTB. For example, results of one large multicenter study of almost 3,000 unselected women pregnant with a singleton gestation across the United States showed that a cervical length of 25 mm was associated with a 15% to 20% incidence of PTB when detected at 28 weeks’ gestation; the incidence rose to 30% to 35% if the short cervix was detected at 20 weeks.⁹ In this cohort, 84% of women had no history of PTB.

A short cervix and a prior PTB (particularly a very early prior PTB) are two major risk factors for PTB. Together, they significantly increase the risk of an early delivery over individual or single factors alone. Among women who have had a prior PTB and who now have a cervical length of less than 25 mm, the risk of recurrent PTB is 35% to 40%. In contrast, women with a prior PTB and a normal cervical length have a significantly lower risk of recurrence—around 10%.¹⁵

If the physical examination is concerning for cervical dilation or prolapsing membranes, women should be counseled about the poor prognosis for the pregnancy, particularly when these findings are detected at a previable or periviable gestational age, regardless of their history of PTB. In these circumstances, in the absence of labor or intra-amniotic infection, a “rescue” cervical cerclage may be considered as a last resort (see page 34 for more on cerclage).

4. What evaluation or monitoring is needed once a short cervix is identified?
Women found to have a short cervix should be evaluated for the presence of preterm labor and intra-amniotic infection. This evaluation may include a sterile speculum examination or digital cervical examination, or both, as well as screening for genitourinary tract infection. Other testing may include a complete blood count with a white blood cell differential and external tocometry with or without fetal heart rate monitoring (based on the gestational age, as appropriate). 

For some women with a short cervix, intra-amniotic infection may be a contributing factor (or it may develop if there are exposed membranes in the vagina). The presence of intra-amniotic infection precludes further expectant management of the pregnancy because of the risk of maternal infectious morbidity, including sepsis.

Women who have intra-amniotic infection are not candidates for any intervention such as cerclage or progesterone supplementation.

If the patient is at or beyond the point of fetal viability at the time her short cervix is detected, consider external fetal heart rate monitoring.

Antenatal corticosteroids can be administered, as appropriate, depending on the perceived risk of delivery.

5. Should I place a cerclage?
Numerous studies have examined the efficacy of ultrasound-indicated cerclage, a surgical procedure to stitch the cervix closed once a short cervix has been detected.

In general, placement of a cervical cerclage is not offered past the point of fetal viability, which is generally in the range of 23 to 25 weeks’ gestation, depending on local institutional and neonatal intensive care unit policies. Confirmed or suspected chorioamnionitis is also a contraindication to cerclage placement.

Among women without a history of PTB who are found to have a short cervix, existing data do not suggest a benefit for cerclage, although vaginal progesterone appears to be a reasonable option (see page 36).^16,17

As for women with a history of PTB, Owen and colleagues studied 302 patients with a cervical length less than 25 mm and a history of spontaneous PTB before 34 weeks.¹⁸ The women were randomly assigned to ultrasound-indicated cerclage or “usual care,” which consisted of recommendations of pelvic rest, physical activity restriction, and education about the symptoms of preterm labor. Otherwise, management was directed by clinical practice at each center. All women treated with cerclage had a reduced risk of previable PTB (<24 weeks’ gestation), and those who had the shortest cervical length (<15 mm) also had a lower risk of delivery before 35 weeks.

The degree of cervical shortening that has “qualified” women for study enrollment has varied between studies, with upper limits ranging from 15 to 25 mm. Berghella and colleagues performed a patient-level meta-analysis to determine whether efficacy of the cerclage varied by cervical length at the time of placement.⁸ They examined 552 women with singleton gestations from four randomized controlled trials that included 208 women with a short cervix and a history of spontaneous PTB. They found a significant reduction in the rate of preterm delivery before 35 weeks’ gestation among women with singleton pregnancies, a short cervix, and a history of spontaneous PTB; the reduction did not vary by the degree of cervical shortening. However, there was no significant reduction in the rate of PTB among the subset of women without a history of spontaneous PTB.

Berghella and colleagues estimated that, if a cervical cerclage were offered to the 8% of women with a prior spontaneous PTB and a cervical length of less than 25 mm, more than 6,500 newborns would be saved each year from perinatal death associated with prematurity.⁸

The placement of a “rescue” cerclage in the setting of cervical dilation with or without prolapsing membranes is associated with high rates of maternal and neonatal morbidity, regardless of the patient’s obstetric history. However, cerclage placement in this setting may be associated with better outcomes than expectant management with bed rest alone.¹⁹ Patients should be carefully counseled about this procedure, including the risk of infection and the possibility that pregnancy may be prolonged only from a previable to a periviable gestational age. Decisions as to whether a patient is a candidate for rescue cerclage should be made in consultation with a maternal-fetal medicine specialist.²⁰

6. Is a cervical pessary beneficial?
The pessary is another “mechanical” treatment similar to cerclage, and it may be helpful in reducing the incidence of PTB among women with a short cervix. In the largest study of this approach, 16,000 primarily low-risk women with singleton gestations were screened for a short cervix. Of these, 385 women with a cervical length of less than 25 mm were randomly assigned to undergo Arabin pessary placement or expectant management.²¹

Among those who received the pessary, the odds ratio (OR) for PTB before 34 weeks was significantly reduced (OR, 0.18; 95% confidence interval [CI], 0.08–0.37), and the OR for adverse composite neonatal outcome also was significantly reduced (OR, 0.14; 95% CI, 0.04–0.39).²¹

The Arabin pessary is not currently approved by the US Food and Drug Administration for this indication in the United States, nor is it available for insertion outside of research studies. Other ring-shaped pessaries are available in the United States, but their use in the setting of a short cervix is considered experimental and off-label. Additional studies of this promising intervention are currently under way.

7. Who is a candidate for supplemental progesterone?
Progesterone is a naturally occurring hormone essential to the maintenance of pregnancy. It has an overall quiescent effect on the myometrium, is known to have anti-inflammatory properties, and inhibits cervical ripening.²² It has been studied in a number of different formulations and doses.

Vaginal progesterone supplementation has been shown to reduce the risk of PTB among women with a shortened cervix regardless of their pregnancy history.^16,17,23,24 In the largest trials of unselected general obstetrics populations (including women with and without a history of PTB), use of vaginal progesterone among women with a short cervix reduced the rates of very early spontaneous PTB (<28 and <32 weeks’ gestation) by 40% to 50%.^16,17 As expected, progesterone also was associated with a significant reduction in the rates of respiratory distress syndrome and composite neonatal morbidity.

Intramuscular (IM) progesterone supplementation has been shown to reduce the rate of recurrent PTB among women with a history of spontaneous PTB. When caring for a woman with a history of PTB who is found to have a short cervix, IM progesterone should be offered if the woman is not already taking it. IM progesterone has not been proven effective among nulliparous women who are incidentally found to have a short cervix; it should not be offered in this situation.²⁵

8. Should the care of women carrying twins or triplets be managed differently?
Yes. Although women with multiple gestations are at higher risk for PTB than women carrying a singleton fetus, no interventions have proven to be effective in this population. Many studies have been limited to twin gestations as a group, with an inability to perform subgroup analyses or enroll women who also have a short cervix, due to sample size and power issues.

Progesterone in multiple gestations
Although several formulations of progesterone—including IM 17-alpha hydroxyprogesterone caproate, micronized progesterone, and progesterone suppositories—have been studied, no randomized trial data have demonstrated a reduction in PTB or neonatal morbidity.^26–29 Individual patient-level data from a meta-analysis of vaginal progesterone in the setting of multiple gestations with a short cervical length suggest trends toward a reduced rate of PTB before 33 weeks’ gestation (relative risk [RR], 0.70; 95% CI, 0.34–1.44) and lower composite neonatal morbidity and mortality (RR, 0.56; 95% CI, 0.30–0.97).³⁰

Mechanical strategies in multiple gestations
No randomized data suggest that a pessary is effective in multiple gestations. In one study of 813 multiple gestations in the Netherlands, women were randomly assigned—regardless of cervical length—to receive a pessary at 16 to 20 weeks versus standard care; no difference in adverse perinatal outcomes was detected between groups.³¹

As for cerclage, although data are limited, some studies suggest that placement of a cerclage in twin gestations with cervical shortening may increase the rate of PTB.³²

Bottom line for multiples
Although women carrying multiple gestations are at higher risk for PTB, data are extremely limited. At present, data do not support routine use of cerclage for a short cervix—and some suggest possible harm. Vaginal progesterone or placement of a pessary may be of benefit but should be used with caution and with the understanding that data are sparse.

CASE RESOLVED
You counsel your nulliparous patient that she has an elevated risk of PTB, based on her cervical length of 18 mm at 20 weeks’ gestation, and evaluate her clinically for evidence of preterm labor. Apart from the short cervix, her examination is unremarkable. You offer her nightly vaginal progesterone suppositories and schedule a visit to reevaluate her cervix in 1 week. If cervical dilation or prolapsing membranes are noted before the age of fetal viability, you will consider placing a “rescue” cervical cerclage.

Had this patient experienced a prior PTB, you would first ensure that she is taking IM 17-alpha hydroxyprogesterone caproate. It also would be reasonable to place an ultrasound-indicated cerclage or begin vaginal progesterone suppositories. Although data are limited on concomitant use of IM and vaginal progesterone, some experts may consider it, on an experimental basis, for patients with a short cervix and a prior PTB.

If this patient were carrying a twin gestation, vaginal progesterone would still be a consideration, provided she is counseled about the limited evidence of its efficacy in this setting. Cerclage would not be appropriate, given the possible risk of harm.

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