OBG Management

Over the past year, much attention has been devoted to labor curves. Is the original Friedman labor curve, which dates to the 1950s, still applicable today? Or do contemporary women labor differently? And if we update our approach to labor management, can we reduce the rate of primary cesarean?

In this Update, we explore these questions, as well as two others:

Is adherence to new labor curves the best way to reduce the rate of primary cesarean?

American College of Obstetricians and Gynecologists. Obstetric Care Consensus No. 1: Safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123(3):693–711.

Cohen WR, Friedman EA. Perils of the new labor management guidelines [published online ahead of print September 16, 2014]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2014.09.008.

In 2012, the cesarean delivery rate in the United States remained at 32.8%, a high percentage when one considers the increased risks that major abdominal surgery poses in both the short and long term (blood loss, transfusion, infection, venous thromboembolism, abnormal placentation, hysterectomy).¹ The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have made it a priority to reduce the cesarean delivery rate, focusing their efforts on the primary cesarean. In March 2014, they jointly issued guidelines on the “Safe prevention of the primary cesarean delivery,” highlighting labor dystocia as a top cause.

When contemporary data from the Consortium on Safe Labor were applied to the original Friedman labor curve, investigators found that the active phase of labor may be slower than previously thought.² The maximum slope for the rate of cervical change was not observed until 6 cm of dilation. This finding potentially changes the point at which arrest of the active phase may be declared. The maximum duration of augmentation with oxytocin also has been extended, based on studies that demonstrated increased vaginal delivery rates.

The Consortium on Safe Labor proposed that, by subjecting a contemporary population to decades-old standards, we have been intervening with primary cesarean too early in the treatment of labor dystocia.

What the guidelines say
The new recommendations from ACOG-SMFM suggest that arrest of the active phase of labor can be declared only when the patient is dilated at least 6 cm with ruptured membranes after either 4 hours of adequate uterine contractions or at least 6 hours of oxytocin administration with inadequate uterine contractions or no cervical change.

Although the recommendations state that there is no maximum duration of the second stage of labor, we may increase the vaginal delivery rate by increasing the duration of pushing to 2 hours for a multiparous patient and 3 hours for a nulliparous patient (with an additional hour when an epidural is given).

Are the recommendations ready for prime time?
In response to the recommendations, Cohen and Friedman (author of the original labor curve) published “Perils of the new labor management guidelines,” cited above. In this commentary, they caution against universal acceptance of the guidelines without further validation. They argue that the analytical method used—and not labor itself—has changed, with possible selection biases and unadjusted confounders altering the shape of the dilatation curve. Cohen and Friedman suggest that serial evaluation of the patient is preferable to an arbitrary cutoff of 6 cm.

They also criticize other aspects of the guidelines, focusing on universal use of intrauterine pressure catheters, amniotomy, and a specific duration of pushing without consideration of descent. A “one size fits all” approach may incur risk to both the mother and the fetus without proven benefit, they contend. Clinical judgment and continuous evaluation of the likelihood and safety of vaginal delivery also are encouraged rather than a reliance on labor curves in isolation.

They urge further validation before adoption of the recommendations. “If we direct our clinical and basic science investigations to the goal of practicing obstetrics in a manner that optimizes maternal and newborn outcomes, the ideal cesarean delivery rate, whatever it may be, will follow,” they write.

What this EVIDENCE means for practice
Proceed with caution when applying labor curves to patients. Use clinical judgment in conjunction with any new guidelines.

Be vigilant for infectious threats to your obstetric population

Jamieson DJ, Uyeki TM, Callaghan WM, Meaney-Delman D, Rasmussen SA. What obstetrician-­gynecologists should know about Ebola: a perspective from the Centers for Disease Control and Prevention. Obstet Gynecol. 2014;124(5):1005–1010. 

American College of Obstetricians and Gynecologists. Committee Opinion No. 614: Management of pregnant women with presumptive exposure to Listeria monocytogenes. Obstet Gynecol. 2014;124(6):1241–1244.

American College of Obstetricians and Gynecologists. Committee Opinion No. 608: Influenza vaccination during pregnancy. Obstet Gynecol. 2014;124(3):648–651.

We no longer consider pregnancy an immunosuppressed state but, rather, a more immune-modulated system. However, there is no question that the unique physiologic state of pregnancy places a woman and her fetus at increased risk for infection. This was devastatingly obvious during the H1N1 epidemic of 2009 and was reemphasized during a 2014 outbreak of Listeria monocytogenes. We are reminded again during the largest Ebola virus outbreak in history in West Africa, where women have been disproportionately affected.

No neonates have survived Ebola
Although Ebola infections in the United States have been very few, vigilance for people at risk of infection and preparedness to act in the case of infection are vitally important.

The Ebola virus is thought to be spread to humans through contact with infected fruit bats or primates. Human-to-human transmission occurs through direct contact with blood or body fluids (urine, feces, sweat, saliva, breast milk, vomit, semen) of an infected person or contaminated objects (needles, syringes). The incubation period is 2 to 21 days (average, 8–10 days).

Infected people become contagious only upon the appearance of fever and symptoms, which include headache, muscle pain, fatigue, weakness, diarrhea, abdominal pain, vomiting, bleeding, and bruising. The differential diagnosis includes malaria, typhoid, Lassa fever, meningococcal disease, influenza, and Marburg virus.

Treatment of Ebola is supportive care and isolation (standard, contact, and droplet precautions). Prevention is through infection-control precautions and isolation and testing of those exposed, with monitoring for 21 days.

Although pregnant women are not thought to be more susceptible to infection, they are at increased risk of severe illness and mortality, as well as spontaneous abortion and pregnancy-related hemorrhage. No neonates of women infected with Ebola have survived to date.

The CDC recommends that physicians screen patients who have traveled to West Africa and those with fevers and implement appropriate isolation and infection-control precautions. Many hospitals have developed Ebola task forces with this in mind.

Updated information is available at www.cdc.gov/vhf/ebola/index.html.

Pregnant women are highly susceptible to Listeriosis
A nationwide food recall in mid-2014 prompted significant media attention to ­L monocytogenes, particularly its effect on pregnant women, who have an incidence of Listerial infection 13 times higher than the general population. Although maternal illness is relatively mild, ranging from a complete lack of symptoms to febrile diarrhea, there is an increased risk to the fetus or neonate of loss, preterm labor, neonatal sepsis, meningitis, and death. The perinatal mortality rate is 29%.

The mainstay of prevention during pregnancy is improved food safety and handling, as well as counseling of pregnant women to avoid unpasteurized soft cheeses, raw milk, and unwashed fruits and vegetables, and to avoid or heat thoroughly lunch meats and hot dogs.

When a pregnant woman is exposed to Listeria, management depends on the clinical scenario, as outlined by ACOG:

Influenza is largely preventable
It is important to remember that one of the most dangerous viruses for pregnant women can be prevented. However, only 38% to 52% of women who should have received the influenza vaccine around the time of pregnancy actually did so between 2009 and 2013, according to the ACOG Committee Opinion cited above. Pregnant and postpartum women are at increased risk of serious illness, prolonged hospitalization, and death from influenza infection.

The vaccine is safe and effective. Not only does it prevent maternal morbidity and mortality, but it reduces neonatal complications. Inactivated vaccine is recommended for all pregnant women at any gestational age during the flu season.

Because many women are hesitant to accept the vaccine, accurate education is essential to dispel misconceptions about it and its components. It has been shown that if an obstetric clinician recommends the vaccine and makes it available, pregnant patients are five to 50 times more likely to receive it. As obstetricians, we are compelled to make this a priority in our practice.

What this EVIDENCE means for practice
Be alert and ready to act if an infectious threat is noted in your obstetric population. Get your flu shot. Give it to your obstetric patients. And don’t forget that ACOG also supports the administration of one dose of the tetanus, diphtheria, and pertussis vaccine during each pregnancy.

How much prenatal screening is too much?

Goetzinger KR, Odibo AO. Screening for abnormal placentation and adverse pregnancy outcomes with maternal serum biomarkers in the second trimester. Prenatal Diagn. 2014;34(7):635–641.

D’Antonio F, Rijo C, Thilaganathan B, et al. Association between first-trimester maternal serum pregnancy associated plasma protein-A and obstetric complications. Prenatal Diagn. 2013;33(9):839–847.

Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.

Martin A, Krishna I, Martina B, et al. Can the quantity of cell-free fetal DNA predict preeclampsia: a systematic review. Prenatal Diagn. 2014;34(7): 685–691.

Audibert F, Boucoiran I, An N, et al. Screening for preeclampsia using first-trimester serum markers and uterine artery Doppler in nulliparous women. Am J Obstet Gynecol. 2010;203(4):383.e1–e8.

Myatt L, Clifton RG, Roberts JM, et al. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012;119(6):1234–1242.

The placenta of a normal pregnancy secretes small amounts of a variety of biomarkers such as alpha-fetoprotein (AFP), human chorionic gonadotropin, unconjugated estriol, inhibin A, pregnancy-associated placental protein A (PAPP-A), soluble fms-like tyrosine kinase, and placental growth factor.

The association between abnormal maternal serum biomarkers and abnormal pregnancy outcomes has been known since the 1970s, when elevated AFP was noted in pregnancies with fetal open neural tube defects. Shortly thereafter, low levels of AFP were associated with fetuses with trisomy 21.

One theory is that the abnormality in pregnancy leads to abnormal regulation at the level of the fetal-placental interface and over- or under-secretion of the various biomarkers. An offshoot of this theory is the idea that abnormal placentation (ie, preeclampsia, fetal growth restriction, accreta) also may be reflected in elevated or suppressed secretion of placental biomarkers, which could be used to screen for these conditions during pregnancy.

PAPP-A is a placental serum marker that is a component of first-trimester genetic screening. It is a marker of placental function, and low levels have been associated with fetal growth restriction, preterm birth, preeclampsia, and fetal loss. Another first-trimester marker associated with adverse outcomes is cell-free fetal DNA. This DNA, found in the maternal blood, is a product of placental apoptosis, and elevated levels have been demonstrated in women who develop preeclampsia.

Although many of the biomarkers listed here are not available specifically as a clinical screening test in the United States, the link to common genetic screens makes it tempting to try to add prediction of preeclampsia and other information to an existing test. If specific numbers are reported on the genetic screen for the different markers, that information is already there, and some companies may flag abnormally high or low levels.

However, although the association between abnormal pregnancy outcomes and abnormal biomarkers is well established in the literature, the clinical predictive value is not—nor is there always an effective intervention available. One could argue that low-dose aspirin, which is already recommended for patients with a prior delivery before 34 weeks due to preeclampsia, or more than one prior pregnancy with preeclampsia, could be recommended for patients identified on early screens to be at increased risk for preeclampsia. This approach should be tested in randomized clinical trials before universal adoption.

What this EVIDENCE means for practice
Although it is tempting to use associations to predict adverse events, the clinical value of doing so has not yet been proven. Exercise caution before potentially causing concern for both you and your patient.

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

Over the past year, much attention has been devoted to labor curves. Is the original Friedman labor curve, which dates to the 1950s, still applicable today? Or do contemporary women labor differently? And if we update our approach to labor management, can we reduce the rate of primary cesarean?

In this Update, we explore these questions, as well as two others:

Is adherence to new labor curves the best way to reduce the rate of primary cesarean?

American College of Obstetricians and Gynecologists. Obstetric Care Consensus No. 1: Safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123(3):693–711.

Cohen WR, Friedman EA. Perils of the new labor management guidelines [published online ahead of print September 16, 2014]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2014.09.008.

In 2012, the cesarean delivery rate in the United States remained at 32.8%, a high percentage when one considers the increased risks that major abdominal surgery poses in both the short and long term (blood loss, transfusion, infection, venous thromboembolism, abnormal placentation, hysterectomy).¹ The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have made it a priority to reduce the cesarean delivery rate, focusing their efforts on the primary cesarean. In March 2014, they jointly issued guidelines on the “Safe prevention of the primary cesarean delivery,” highlighting labor dystocia as a top cause.

When contemporary data from the Consortium on Safe Labor were applied to the original Friedman labor curve, investigators found that the active phase of labor may be slower than previously thought.² The maximum slope for the rate of cervical change was not observed until 6 cm of dilation. This finding potentially changes the point at which arrest of the active phase may be declared. The maximum duration of augmentation with oxytocin also has been extended, based on studies that demonstrated increased vaginal delivery rates.

The Consortium on Safe Labor proposed that, by subjecting a contemporary population to decades-old standards, we have been intervening with primary cesarean too early in the treatment of labor dystocia.

What the guidelines say
The new recommendations from ACOG-SMFM suggest that arrest of the active phase of labor can be declared only when the patient is dilated at least 6 cm with ruptured membranes after either 4 hours of adequate uterine contractions or at least 6 hours of oxytocin administration with inadequate uterine contractions or no cervical change.

Although the recommendations state that there is no maximum duration of the second stage of labor, we may increase the vaginal delivery rate by increasing the duration of pushing to 2 hours for a multiparous patient and 3 hours for a nulliparous patient (with an additional hour when an epidural is given).

Are the recommendations ready for prime time?
In response to the recommendations, Cohen and Friedman (author of the original labor curve) published “Perils of the new labor management guidelines,” cited above. In this commentary, they caution against universal acceptance of the guidelines without further validation. They argue that the analytical method used—and not labor itself—has changed, with possible selection biases and unadjusted confounders altering the shape of the dilatation curve. Cohen and Friedman suggest that serial evaluation of the patient is preferable to an arbitrary cutoff of 6 cm.

They also criticize other aspects of the guidelines, focusing on universal use of intrauterine pressure catheters, amniotomy, and a specific duration of pushing without consideration of descent. A “one size fits all” approach may incur risk to both the mother and the fetus without proven benefit, they contend. Clinical judgment and continuous evaluation of the likelihood and safety of vaginal delivery also are encouraged rather than a reliance on labor curves in isolation.

They urge further validation before adoption of the recommendations. “If we direct our clinical and basic science investigations to the goal of practicing obstetrics in a manner that optimizes maternal and newborn outcomes, the ideal cesarean delivery rate, whatever it may be, will follow,” they write.

What this EVIDENCE means for practice
Proceed with caution when applying labor curves to patients. Use clinical judgment in conjunction with any new guidelines.

Be vigilant for infectious threats to your obstetric population

Jamieson DJ, Uyeki TM, Callaghan WM, Meaney-Delman D, Rasmussen SA. What obstetrician-­gynecologists should know about Ebola: a perspective from the Centers for Disease Control and Prevention. Obstet Gynecol. 2014;124(5):1005–1010. 

American College of Obstetricians and Gynecologists. Committee Opinion No. 614: Management of pregnant women with presumptive exposure to Listeria monocytogenes. Obstet Gynecol. 2014;124(6):1241–1244.

American College of Obstetricians and Gynecologists. Committee Opinion No. 608: Influenza vaccination during pregnancy. Obstet Gynecol. 2014;124(3):648–651.

We no longer consider pregnancy an immunosuppressed state but, rather, a more immune-modulated system. However, there is no question that the unique physiologic state of pregnancy places a woman and her fetus at increased risk for infection. This was devastatingly obvious during the H1N1 epidemic of 2009 and was reemphasized during a 2014 outbreak of Listeria monocytogenes. We are reminded again during the largest Ebola virus outbreak in history in West Africa, where women have been disproportionately affected.

No neonates have survived Ebola
Although Ebola infections in the United States have been very few, vigilance for people at risk of infection and preparedness to act in the case of infection are vitally important.

The Ebola virus is thought to be spread to humans through contact with infected fruit bats or primates. Human-to-human transmission occurs through direct contact with blood or body fluids (urine, feces, sweat, saliva, breast milk, vomit, semen) of an infected person or contaminated objects (needles, syringes). The incubation period is 2 to 21 days (average, 8–10 days).

Infected people become contagious only upon the appearance of fever and symptoms, which include headache, muscle pain, fatigue, weakness, diarrhea, abdominal pain, vomiting, bleeding, and bruising. The differential diagnosis includes malaria, typhoid, Lassa fever, meningococcal disease, influenza, and Marburg virus.

Treatment of Ebola is supportive care and isolation (standard, contact, and droplet precautions). Prevention is through infection-control precautions and isolation and testing of those exposed, with monitoring for 21 days.

Although pregnant women are not thought to be more susceptible to infection, they are at increased risk of severe illness and mortality, as well as spontaneous abortion and pregnancy-related hemorrhage. No neonates of women infected with Ebola have survived to date.

The CDC recommends that physicians screen patients who have traveled to West Africa and those with fevers and implement appropriate isolation and infection-control precautions. Many hospitals have developed Ebola task forces with this in mind.

Updated information is available at www.cdc.gov/vhf/ebola/index.html.

Pregnant women are highly susceptible to Listeriosis
A nationwide food recall in mid-2014 prompted significant media attention to ­L monocytogenes, particularly its effect on pregnant women, who have an incidence of Listerial infection 13 times higher than the general population. Although maternal illness is relatively mild, ranging from a complete lack of symptoms to febrile diarrhea, there is an increased risk to the fetus or neonate of loss, preterm labor, neonatal sepsis, meningitis, and death. The perinatal mortality rate is 29%.

The mainstay of prevention during pregnancy is improved food safety and handling, as well as counseling of pregnant women to avoid unpasteurized soft cheeses, raw milk, and unwashed fruits and vegetables, and to avoid or heat thoroughly lunch meats and hot dogs.

When a pregnant woman is exposed to Listeria, management depends on the clinical scenario, as outlined by ACOG:

Influenza is largely preventable
It is important to remember that one of the most dangerous viruses for pregnant women can be prevented. However, only 38% to 52% of women who should have received the influenza vaccine around the time of pregnancy actually did so between 2009 and 2013, according to the ACOG Committee Opinion cited above. Pregnant and postpartum women are at increased risk of serious illness, prolonged hospitalization, and death from influenza infection.

The vaccine is safe and effective. Not only does it prevent maternal morbidity and mortality, but it reduces neonatal complications. Inactivated vaccine is recommended for all pregnant women at any gestational age during the flu season.

Because many women are hesitant to accept the vaccine, accurate education is essential to dispel misconceptions about it and its components. It has been shown that if an obstetric clinician recommends the vaccine and makes it available, pregnant patients are five to 50 times more likely to receive it. As obstetricians, we are compelled to make this a priority in our practice.

What this EVIDENCE means for practice
Be alert and ready to act if an infectious threat is noted in your obstetric population. Get your flu shot. Give it to your obstetric patients. And don’t forget that ACOG also supports the administration of one dose of the tetanus, diphtheria, and pertussis vaccine during each pregnancy.

How much prenatal screening is too much?

Goetzinger KR, Odibo AO. Screening for abnormal placentation and adverse pregnancy outcomes with maternal serum biomarkers in the second trimester. Prenatal Diagn. 2014;34(7):635–641.

D’Antonio F, Rijo C, Thilaganathan B, et al. Association between first-trimester maternal serum pregnancy associated plasma protein-A and obstetric complications. Prenatal Diagn. 2013;33(9):839–847.

Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.

Martin A, Krishna I, Martina B, et al. Can the quantity of cell-free fetal DNA predict preeclampsia: a systematic review. Prenatal Diagn. 2014;34(7): 685–691.

Audibert F, Boucoiran I, An N, et al. Screening for preeclampsia using first-trimester serum markers and uterine artery Doppler in nulliparous women. Am J Obstet Gynecol. 2010;203(4):383.e1–e8.

Myatt L, Clifton RG, Roberts JM, et al. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012;119(6):1234–1242.

The placenta of a normal pregnancy secretes small amounts of a variety of biomarkers such as alpha-fetoprotein (AFP), human chorionic gonadotropin, unconjugated estriol, inhibin A, pregnancy-associated placental protein A (PAPP-A), soluble fms-like tyrosine kinase, and placental growth factor.

The association between abnormal maternal serum biomarkers and abnormal pregnancy outcomes has been known since the 1970s, when elevated AFP was noted in pregnancies with fetal open neural tube defects. Shortly thereafter, low levels of AFP were associated with fetuses with trisomy 21.

One theory is that the abnormality in pregnancy leads to abnormal regulation at the level of the fetal-placental interface and over- or under-secretion of the various biomarkers. An offshoot of this theory is the idea that abnormal placentation (ie, preeclampsia, fetal growth restriction, accreta) also may be reflected in elevated or suppressed secretion of placental biomarkers, which could be used to screen for these conditions during pregnancy.

PAPP-A is a placental serum marker that is a component of first-trimester genetic screening. It is a marker of placental function, and low levels have been associated with fetal growth restriction, preterm birth, preeclampsia, and fetal loss. Another first-trimester marker associated with adverse outcomes is cell-free fetal DNA. This DNA, found in the maternal blood, is a product of placental apoptosis, and elevated levels have been demonstrated in women who develop preeclampsia.

Although many of the biomarkers listed here are not available specifically as a clinical screening test in the United States, the link to common genetic screens makes it tempting to try to add prediction of preeclampsia and other information to an existing test. If specific numbers are reported on the genetic screen for the different markers, that information is already there, and some companies may flag abnormally high or low levels.

However, although the association between abnormal pregnancy outcomes and abnormal biomarkers is well established in the literature, the clinical predictive value is not—nor is there always an effective intervention available. One could argue that low-dose aspirin, which is already recommended for patients with a prior delivery before 34 weeks due to preeclampsia, or more than one prior pregnancy with preeclampsia, could be recommended for patients identified on early screens to be at increased risk for preeclampsia. This approach should be tested in randomized clinical trials before universal adoption.

What this EVIDENCE means for practice
Although it is tempting to use associations to predict adverse events, the clinical value of doing so has not yet been proven. Exercise caution before potentially causing concern for both you and your patient.

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

Over the past year, much attention has been devoted to labor curves. Is the original Friedman labor curve, which dates to the 1950s, still applicable today? Or do contemporary women labor differently? And if we update our approach to labor management, can we reduce the rate of primary cesarean?

In this Update, we explore these questions, as well as two others:

Is adherence to new labor curves the best way to reduce the rate of primary cesarean?

American College of Obstetricians and Gynecologists. Obstetric Care Consensus No. 1: Safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123(3):693–711.

Cohen WR, Friedman EA. Perils of the new labor management guidelines [published online ahead of print September 16, 2014]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2014.09.008.

In 2012, the cesarean delivery rate in the United States remained at 32.8%, a high percentage when one considers the increased risks that major abdominal surgery poses in both the short and long term (blood loss, transfusion, infection, venous thromboembolism, abnormal placentation, hysterectomy).¹ The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have made it a priority to reduce the cesarean delivery rate, focusing their efforts on the primary cesarean. In March 2014, they jointly issued guidelines on the “Safe prevention of the primary cesarean delivery,” highlighting labor dystocia as a top cause.

When contemporary data from the Consortium on Safe Labor were applied to the original Friedman labor curve, investigators found that the active phase of labor may be slower than previously thought.² The maximum slope for the rate of cervical change was not observed until 6 cm of dilation. This finding potentially changes the point at which arrest of the active phase may be declared. The maximum duration of augmentation with oxytocin also has been extended, based on studies that demonstrated increased vaginal delivery rates.

The Consortium on Safe Labor proposed that, by subjecting a contemporary population to decades-old standards, we have been intervening with primary cesarean too early in the treatment of labor dystocia.

What the guidelines say
The new recommendations from ACOG-SMFM suggest that arrest of the active phase of labor can be declared only when the patient is dilated at least 6 cm with ruptured membranes after either 4 hours of adequate uterine contractions or at least 6 hours of oxytocin administration with inadequate uterine contractions or no cervical change.

Although the recommendations state that there is no maximum duration of the second stage of labor, we may increase the vaginal delivery rate by increasing the duration of pushing to 2 hours for a multiparous patient and 3 hours for a nulliparous patient (with an additional hour when an epidural is given).

Are the recommendations ready for prime time?
In response to the recommendations, Cohen and Friedman (author of the original labor curve) published “Perils of the new labor management guidelines,” cited above. In this commentary, they caution against universal acceptance of the guidelines without further validation. They argue that the analytical method used—and not labor itself—has changed, with possible selection biases and unadjusted confounders altering the shape of the dilatation curve. Cohen and Friedman suggest that serial evaluation of the patient is preferable to an arbitrary cutoff of 6 cm.

They also criticize other aspects of the guidelines, focusing on universal use of intrauterine pressure catheters, amniotomy, and a specific duration of pushing without consideration of descent. A “one size fits all” approach may incur risk to both the mother and the fetus without proven benefit, they contend. Clinical judgment and continuous evaluation of the likelihood and safety of vaginal delivery also are encouraged rather than a reliance on labor curves in isolation.

They urge further validation before adoption of the recommendations. “If we direct our clinical and basic science investigations to the goal of practicing obstetrics in a manner that optimizes maternal and newborn outcomes, the ideal cesarean delivery rate, whatever it may be, will follow,” they write.

What this EVIDENCE means for practice
Proceed with caution when applying labor curves to patients. Use clinical judgment in conjunction with any new guidelines.

Be vigilant for infectious threats to your obstetric population

Jamieson DJ, Uyeki TM, Callaghan WM, Meaney-Delman D, Rasmussen SA. What obstetrician-­gynecologists should know about Ebola: a perspective from the Centers for Disease Control and Prevention. Obstet Gynecol. 2014;124(5):1005–1010. 

American College of Obstetricians and Gynecologists. Committee Opinion No. 614: Management of pregnant women with presumptive exposure to Listeria monocytogenes. Obstet Gynecol. 2014;124(6):1241–1244.

American College of Obstetricians and Gynecologists. Committee Opinion No. 608: Influenza vaccination during pregnancy. Obstet Gynecol. 2014;124(3):648–651.

We no longer consider pregnancy an immunosuppressed state but, rather, a more immune-modulated system. However, there is no question that the unique physiologic state of pregnancy places a woman and her fetus at increased risk for infection. This was devastatingly obvious during the H1N1 epidemic of 2009 and was reemphasized during a 2014 outbreak of Listeria monocytogenes. We are reminded again during the largest Ebola virus outbreak in history in West Africa, where women have been disproportionately affected.

No neonates have survived Ebola
Although Ebola infections in the United States have been very few, vigilance for people at risk of infection and preparedness to act in the case of infection are vitally important.

The Ebola virus is thought to be spread to humans through contact with infected fruit bats or primates. Human-to-human transmission occurs through direct contact with blood or body fluids (urine, feces, sweat, saliva, breast milk, vomit, semen) of an infected person or contaminated objects (needles, syringes). The incubation period is 2 to 21 days (average, 8–10 days).

Infected people become contagious only upon the appearance of fever and symptoms, which include headache, muscle pain, fatigue, weakness, diarrhea, abdominal pain, vomiting, bleeding, and bruising. The differential diagnosis includes malaria, typhoid, Lassa fever, meningococcal disease, influenza, and Marburg virus.

Treatment of Ebola is supportive care and isolation (standard, contact, and droplet precautions). Prevention is through infection-control precautions and isolation and testing of those exposed, with monitoring for 21 days.

Although pregnant women are not thought to be more susceptible to infection, they are at increased risk of severe illness and mortality, as well as spontaneous abortion and pregnancy-related hemorrhage. No neonates of women infected with Ebola have survived to date.

The CDC recommends that physicians screen patients who have traveled to West Africa and those with fevers and implement appropriate isolation and infection-control precautions. Many hospitals have developed Ebola task forces with this in mind.

Updated information is available at www.cdc.gov/vhf/ebola/index.html.

Pregnant women are highly susceptible to Listeriosis
A nationwide food recall in mid-2014 prompted significant media attention to ­L monocytogenes, particularly its effect on pregnant women, who have an incidence of Listerial infection 13 times higher than the general population. Although maternal illness is relatively mild, ranging from a complete lack of symptoms to febrile diarrhea, there is an increased risk to the fetus or neonate of loss, preterm labor, neonatal sepsis, meningitis, and death. The perinatal mortality rate is 29%.

The mainstay of prevention during pregnancy is improved food safety and handling, as well as counseling of pregnant women to avoid unpasteurized soft cheeses, raw milk, and unwashed fruits and vegetables, and to avoid or heat thoroughly lunch meats and hot dogs.

When a pregnant woman is exposed to Listeria, management depends on the clinical scenario, as outlined by ACOG:

Influenza is largely preventable
It is important to remember that one of the most dangerous viruses for pregnant women can be prevented. However, only 38% to 52% of women who should have received the influenza vaccine around the time of pregnancy actually did so between 2009 and 2013, according to the ACOG Committee Opinion cited above. Pregnant and postpartum women are at increased risk of serious illness, prolonged hospitalization, and death from influenza infection.

The vaccine is safe and effective. Not only does it prevent maternal morbidity and mortality, but it reduces neonatal complications. Inactivated vaccine is recommended for all pregnant women at any gestational age during the flu season.

Because many women are hesitant to accept the vaccine, accurate education is essential to dispel misconceptions about it and its components. It has been shown that if an obstetric clinician recommends the vaccine and makes it available, pregnant patients are five to 50 times more likely to receive it. As obstetricians, we are compelled to make this a priority in our practice.

What this EVIDENCE means for practice
Be alert and ready to act if an infectious threat is noted in your obstetric population. Get your flu shot. Give it to your obstetric patients. And don’t forget that ACOG also supports the administration of one dose of the tetanus, diphtheria, and pertussis vaccine during each pregnancy.

How much prenatal screening is too much?

Goetzinger KR, Odibo AO. Screening for abnormal placentation and adverse pregnancy outcomes with maternal serum biomarkers in the second trimester. Prenatal Diagn. 2014;34(7):635–641.

D’Antonio F, Rijo C, Thilaganathan B, et al. Association between first-trimester maternal serum pregnancy associated plasma protein-A and obstetric complications. Prenatal Diagn. 2013;33(9):839–847.

Dugoff L; Society for Maternal-Fetal Medicine. First- and second-trimester maternal serum markers for aneuploidy and adverse obstetric outcomes. Obstet Gynecol. 2010;115(5):1052–1061.

Martin A, Krishna I, Martina B, et al. Can the quantity of cell-free fetal DNA predict preeclampsia: a systematic review. Prenatal Diagn. 2014;34(7): 685–691.

Audibert F, Boucoiran I, An N, et al. Screening for preeclampsia using first-trimester serum markers and uterine artery Doppler in nulliparous women. Am J Obstet Gynecol. 2010;203(4):383.e1–e8.

Myatt L, Clifton RG, Roberts JM, et al. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012;119(6):1234–1242.

The placenta of a normal pregnancy secretes small amounts of a variety of biomarkers such as alpha-fetoprotein (AFP), human chorionic gonadotropin, unconjugated estriol, inhibin A, pregnancy-associated placental protein A (PAPP-A), soluble fms-like tyrosine kinase, and placental growth factor.

The association between abnormal maternal serum biomarkers and abnormal pregnancy outcomes has been known since the 1970s, when elevated AFP was noted in pregnancies with fetal open neural tube defects. Shortly thereafter, low levels of AFP were associated with fetuses with trisomy 21.

One theory is that the abnormality in pregnancy leads to abnormal regulation at the level of the fetal-placental interface and over- or under-secretion of the various biomarkers. An offshoot of this theory is the idea that abnormal placentation (ie, preeclampsia, fetal growth restriction, accreta) also may be reflected in elevated or suppressed secretion of placental biomarkers, which could be used to screen for these conditions during pregnancy.

PAPP-A is a placental serum marker that is a component of first-trimester genetic screening. It is a marker of placental function, and low levels have been associated with fetal growth restriction, preterm birth, preeclampsia, and fetal loss. Another first-trimester marker associated with adverse outcomes is cell-free fetal DNA. This DNA, found in the maternal blood, is a product of placental apoptosis, and elevated levels have been demonstrated in women who develop preeclampsia.

Although many of the biomarkers listed here are not available specifically as a clinical screening test in the United States, the link to common genetic screens makes it tempting to try to add prediction of preeclampsia and other information to an existing test. If specific numbers are reported on the genetic screen for the different markers, that information is already there, and some companies may flag abnormally high or low levels.

However, although the association between abnormal pregnancy outcomes and abnormal biomarkers is well established in the literature, the clinical predictive value is not—nor is there always an effective intervention available. One could argue that low-dose aspirin, which is already recommended for patients with a prior delivery before 34 weeks due to preeclampsia, or more than one prior pregnancy with preeclampsia, could be recommended for patients identified on early screens to be at increased risk for preeclampsia. This approach should be tested in randomized clinical trials before universal adoption.

What this EVIDENCE means for practice
Although it is tempting to use associations to predict adverse events, the clinical value of doing so has not yet been proven. Exercise caution before potentially causing concern for both you and your patient.

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

Approximately 15% of early pregnancies are complicated by pelvic or abdominal pain and uterine bleeding or spotting. In these situations, you must determine whether your patient has a viable intrauterine pregnancy, a pregnancy that will end in a miscarriage (spontaneous abortion), or an ectopic pregnancy.

To guide you to the correct diagnosis, a medical history and physical examination can be helpful. For example, a woman with a prior ectopic pregnancy who now has an early pregnancy complicated by pelvic pain and uterine bleeding is at high risk for an ectopic pregnancy. Physical examination also is important; if the pelvic examination reveals a dilated cervix with pregnancy tissue in the cervical os it is likely that a miscarriage is in progress. For most cases of early pregnancy complicated by pelvic pain and/or uterine bleeding, however, a pelvic sonogram and serial quantitative ­measurement of ­human chorionic gonadotropin (hCG) are needed to achieve the correct diagnosis.

Here I outline the clinical markers for transvaginal ultrasonography that indicate a viable or failed intrauterine pregnancy as well as an ectopic pregnancy. I also present data on single vs serial hCG measurement and discuss serial hCG levels that indicate viable or nonviable intrauterine or ectopic ­pregnancy.

Is an early gestation viable? Clinical evaluationTransvaginal pelvic ultrasoundTransvaginal and transabdominal ultrasonography play a critical role in evaluating early pregnancy problems. In a normal pregnancy, key developmental milestones that can be observed reliably on ultrasound are^1,2:

A pelvic ultrasound also may provide evidence that an intra­uterine pregnancy will fail and result in a miscarriage. Findings diagnostic of a failed intrauterine pregnancy ­include³:

Findings suspicious for a failing intrauterine pregnancy include³:

When it’s an ectopic pregnancy. ­Definitive ultrasonographic evidence of an ectopic pregnancy is identification of a fetal heartbeat outside the uterus or a gestational sac and yolk sac outside of the uterus. An adnexal mass can be identified on ultrasonography in most cases of ectopic pregnancy. In one study of 291 ectopic pregnancies, an adnexal mass was identified in 94% of cases, and a moderate to large amount of free pelvic fluid was found in 36% of cases.⁴ The adnexal masses included nonspecific (54% of all ectopic cases), a tubal ring without a yolk sac or embryo (25%), a yolk sac but no embryonic heartbeat (8%), and an embryo with cardiac activity (7%).

In clinical units with high-­quality gynecologic ultrasonography available, most ectopic pregnancies will be detected on initial scan and only 10% to 15% of ectopic pregnancies will have an ultrasound finding of no intrauterine pregnancy and no evidence for an extrauterine pregnancy.⁵

Almost all (in the range of 99%) viable intrauterine pregnancies demonstrate an increase in hCG level of 53% or more over 48 hours, whereas only 21% of ectopic pregnancies demonstrate a rise of 53% or more.⁷

Most pregnancies that will end in a miscarriage demonstrate a decrease in hCG level over 48 hours. If the initial hCG value is 2,000 mIU/mL, 90% of pregnancies that will end in miscarriage will have an approximate 30% decrease in hCG over 48 hours. If the initial hCG is 1,000 mIU/mL, 95% of spontaneous abortions will have a 28% decline in 48 hours.⁷ About 10% of ectopic pregnancies also will demonstrate a 30% decrease in hCG over 48 hours.

A minor disadvantage of serial hCG measurements is that patients may become anxious and fearful as they await the result of life-altering test results.

When a gestation is found to be nonviable A viable intrauterine pregnancy is highly unlikely in a woman with no ultrasound evidence of an intrauterine pregnancy or an adnexal mass and an hCG level that rises very little, plateaus, or decreases over 48 hours. In this situation, a Karman cannula aspiration of uterine contents with rush pathology analysis can help clarify the likely diagnosis and guide therapy.

Women with documented ­villi on pathology likely are experiencing a miscarriage and can have their hCG level followed to resolution. Women with no documented villi and no decrease in hCG after the Karman
cannula aspiration can be presumed to have an ectopic pregnancy. If stable, these women may be candidates for treatment with methotrexate.^8,9

Many experts have counseled against the use of a single hCG measurement in the discriminatory zone of 1,500 to 2,000 mIU/mL to trigger methotrexate treatment. Here is a sampling of their advice:

“An hCG level of 2,000 mIU/mL, without ultrasound findings of intrauterine pregnancy, while suggestive of abnormal pregnancy, is not diagnostic. Per the results of recent studies, it is reasonable to closely follow up rather than treat many of these early, stable cases of ectopic pregnancy.”
                                                                                                                                                                    —Mehta et al.¹

“Our data demonstrate that using a single value of serum hCG in a pregnancy of unknown location (PUL) population is of limited value.... A significant proportion of failing PULs and early intrauterine pregnancies in a PUL population have high serum hCG levels at presentation.”
                                                                                                                                                                    —Condus et al.²

“The hCG discriminatory level should not be used to determine the management of a hemodynamically stable patient with suspected ectopic pregnancy, if sonography demonstrates no findings of intrauterine or ectopic pregnancy.”
                                                                                                                                                                    —Doubilet et al.³

“There is almost no reason to give methotrexate on first encounter with a patient. If a patient is symptomatic with severe pain or signs of rupture, a surgical approach is indicated and methotrexate is contraindicated.”
                                                                                                                                                                    —Barnhart et al.⁴

[When using the discriminatory zone]... “there is a chance of harming a viable intrauterine pregnancy, especially if the hCG level is 2000 to 3000 mIU/mL.... There is limited risk in taking a few extra days to make a definitive diagnosis in a woman with a pregnancy of unknown location who has no signs or symptoms of rupture and no ultrasonographic evidence of ectopic pregnancy.”
                                                                                                                                                                    —Doubliet et al.³

“Viable intrauterine pregnancy is possible in patients with pregnancy of unknown location and hCG levels above the generally accept discriminatory zone, strict adherence to which can potentially disrupt a normal pregnancy. We support the need for judicious use of the hCG discriminatory level in hemodynamically stable patients with pregnancy of unknown location, and the decision to intervene should not be based solely on a single hCG level.”
                                                                                                                                                                    —Ko and Cheung.⁵

References

Stop using the discriminatory zone and a single hCG measurement to trigger clinical intervention As noted above, a single hCG measurement is of very little value in determining whether an early pregnancy is a viable or nonviable intrauterine pregnancy or is ectopic. Many experts have reported that if a single hCG measurement shows a value of more than 1,500 mIU/mL and a pelvic ultrasound shows no intrauterine pregnancy, an ectopic or nonviable intrauterine pregnancy is likely. Some experts have used the presence of an hCG value of more  than 1,500 mIU/mL plus an ultrasound scan without evidence of an intrauterine pregnancy to clinically diagnose the absence of a viable intrauterine pregnancy and administer methotrexate to treat a presumptive ectopic pregnancy. Many experts believe, however, that this approach will necessarily result in the treatment of viable intrauterine pregnancies with methotrexate.^5,10

Based on one analysis, for 100 women with an initial hCG value between 2,000 and 3,000 mIU/mL and no intrauterine pregnancy or adnexal mass seen on ultrasound, follow-up will reveal that 65.5% had a failed intrauterine pregnancy, 33% had an ectopic pregnancy, and 1.5% had a viable intrauterine pregnancy.^3,10,11 If all of these 100 women had been treated with methotrexate for a presumed ectopic pregnancy, approximately two women with a viable intrauterine pregnancy would have been exposed to methotrexate. This exposure would likely result in either a pregnancy loss or, if the pregnancy continues, an increased risk of fetal anomalies.

If the patient is obese, has fibroids, or has adenomyosis, she has an increased risk of an ultrasound failing to detect an early intrauterine pregnancy when the hCG value ranges from 1,500 to 3,000 mIU/mL.¹² If the discriminatory zone is raised to 4,000 mIU/mL, the likelihood of mistakenly diagnosing a viable intrauterine pregnancy as a failed or ectopic pregnancy is much less (but not zero).

There is almost no clinical situation in which methotrexate should be given to a patient suspected of having an ectopic pregnancy on the first visit, unless ultrasound demonstrates an adnexal mass indicative of ectopic pregnancy.^13,14 If the patient has severe pain or bleeding, or has signs consistent with a ruptured ectopic pregnancy, surgical intervention likely is warranted. If the patient is clinically stable, a safe option is to repeat the hCG measurement in 48 hours, with an ultrasound if ­indicated.

The discriminatory zone is an interesting and elegant idea. But in practice it is fraught with serious dangers, the greatest of which is methotrexate administration to a patient with a viable intrauterine gestation. My advice is that gynecologists should stop relying on a discriminatory zone of 1,500 to 2,000 mIU/mL to trigger clinical intervention.  

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

Approximately 15% of early pregnancies are complicated by pelvic or abdominal pain and uterine bleeding or spotting. In these situations, you must determine whether your patient has a viable intrauterine pregnancy, a pregnancy that will end in a miscarriage (spontaneous abortion), or an ectopic pregnancy.

To guide you to the correct diagnosis, a medical history and physical examination can be helpful. For example, a woman with a prior ectopic pregnancy who now has an early pregnancy complicated by pelvic pain and uterine bleeding is at high risk for an ectopic pregnancy. Physical examination also is important; if the pelvic examination reveals a dilated cervix with pregnancy tissue in the cervical os it is likely that a miscarriage is in progress. For most cases of early pregnancy complicated by pelvic pain and/or uterine bleeding, however, a pelvic sonogram and serial quantitative ­measurement of ­human chorionic gonadotropin (hCG) are needed to achieve the correct diagnosis.

Here I outline the clinical markers for transvaginal ultrasonography that indicate a viable or failed intrauterine pregnancy as well as an ectopic pregnancy. I also present data on single vs serial hCG measurement and discuss serial hCG levels that indicate viable or nonviable intrauterine or ectopic ­pregnancy.

Is an early gestation viable? Clinical evaluationTransvaginal pelvic ultrasoundTransvaginal and transabdominal ultrasonography play a critical role in evaluating early pregnancy problems. In a normal pregnancy, key developmental milestones that can be observed reliably on ultrasound are^1,2:

A pelvic ultrasound also may provide evidence that an intra­uterine pregnancy will fail and result in a miscarriage. Findings diagnostic of a failed intrauterine pregnancy ­include³:

Findings suspicious for a failing intrauterine pregnancy include³:

When it’s an ectopic pregnancy. ­Definitive ultrasonographic evidence of an ectopic pregnancy is identification of a fetal heartbeat outside the uterus or a gestational sac and yolk sac outside of the uterus. An adnexal mass can be identified on ultrasonography in most cases of ectopic pregnancy. In one study of 291 ectopic pregnancies, an adnexal mass was identified in 94% of cases, and a moderate to large amount of free pelvic fluid was found in 36% of cases.⁴ The adnexal masses included nonspecific (54% of all ectopic cases), a tubal ring without a yolk sac or embryo (25%), a yolk sac but no embryonic heartbeat (8%), and an embryo with cardiac activity (7%).

In clinical units with high-­quality gynecologic ultrasonography available, most ectopic pregnancies will be detected on initial scan and only 10% to 15% of ectopic pregnancies will have an ultrasound finding of no intrauterine pregnancy and no evidence for an extrauterine pregnancy.⁵

Almost all (in the range of 99%) viable intrauterine pregnancies demonstrate an increase in hCG level of 53% or more over 48 hours, whereas only 21% of ectopic pregnancies demonstrate a rise of 53% or more.⁷

Most pregnancies that will end in a miscarriage demonstrate a decrease in hCG level over 48 hours. If the initial hCG value is 2,000 mIU/mL, 90% of pregnancies that will end in miscarriage will have an approximate 30% decrease in hCG over 48 hours. If the initial hCG is 1,000 mIU/mL, 95% of spontaneous abortions will have a 28% decline in 48 hours.⁷ About 10% of ectopic pregnancies also will demonstrate a 30% decrease in hCG over 48 hours.

A minor disadvantage of serial hCG measurements is that patients may become anxious and fearful as they await the result of life-altering test results.

When a gestation is found to be nonviable A viable intrauterine pregnancy is highly unlikely in a woman with no ultrasound evidence of an intrauterine pregnancy or an adnexal mass and an hCG level that rises very little, plateaus, or decreases over 48 hours. In this situation, a Karman cannula aspiration of uterine contents with rush pathology analysis can help clarify the likely diagnosis and guide therapy.

Women with documented ­villi on pathology likely are experiencing a miscarriage and can have their hCG level followed to resolution. Women with no documented villi and no decrease in hCG after the Karman
cannula aspiration can be presumed to have an ectopic pregnancy. If stable, these women may be candidates for treatment with methotrexate.^8,9

Many experts have counseled against the use of a single hCG measurement in the discriminatory zone of 1,500 to 2,000 mIU/mL to trigger methotrexate treatment. Here is a sampling of their advice:

“An hCG level of 2,000 mIU/mL, without ultrasound findings of intrauterine pregnancy, while suggestive of abnormal pregnancy, is not diagnostic. Per the results of recent studies, it is reasonable to closely follow up rather than treat many of these early, stable cases of ectopic pregnancy.”
                                                                                                                                                                    —Mehta et al.¹

“Our data demonstrate that using a single value of serum hCG in a pregnancy of unknown location (PUL) population is of limited value.... A significant proportion of failing PULs and early intrauterine pregnancies in a PUL population have high serum hCG levels at presentation.”
                                                                                                                                                                    —Condus et al.²

“The hCG discriminatory level should not be used to determine the management of a hemodynamically stable patient with suspected ectopic pregnancy, if sonography demonstrates no findings of intrauterine or ectopic pregnancy.”
                                                                                                                                                                    —Doubilet et al.³

“There is almost no reason to give methotrexate on first encounter with a patient. If a patient is symptomatic with severe pain or signs of rupture, a surgical approach is indicated and methotrexate is contraindicated.”
                                                                                                                                                                    —Barnhart et al.⁴

[When using the discriminatory zone]... “there is a chance of harming a viable intrauterine pregnancy, especially if the hCG level is 2000 to 3000 mIU/mL.... There is limited risk in taking a few extra days to make a definitive diagnosis in a woman with a pregnancy of unknown location who has no signs or symptoms of rupture and no ultrasonographic evidence of ectopic pregnancy.”
                                                                                                                                                                    —Doubliet et al.³

“Viable intrauterine pregnancy is possible in patients with pregnancy of unknown location and hCG levels above the generally accept discriminatory zone, strict adherence to which can potentially disrupt a normal pregnancy. We support the need for judicious use of the hCG discriminatory level in hemodynamically stable patients with pregnancy of unknown location, and the decision to intervene should not be based solely on a single hCG level.”
                                                                                                                                                                    —Ko and Cheung.⁵

References

Stop using the discriminatory zone and a single hCG measurement to trigger clinical intervention As noted above, a single hCG measurement is of very little value in determining whether an early pregnancy is a viable or nonviable intrauterine pregnancy or is ectopic. Many experts have reported that if a single hCG measurement shows a value of more than 1,500 mIU/mL and a pelvic ultrasound shows no intrauterine pregnancy, an ectopic or nonviable intrauterine pregnancy is likely. Some experts have used the presence of an hCG value of more  than 1,500 mIU/mL plus an ultrasound scan without evidence of an intrauterine pregnancy to clinically diagnose the absence of a viable intrauterine pregnancy and administer methotrexate to treat a presumptive ectopic pregnancy. Many experts believe, however, that this approach will necessarily result in the treatment of viable intrauterine pregnancies with methotrexate.^5,10

Based on one analysis, for 100 women with an initial hCG value between 2,000 and 3,000 mIU/mL and no intrauterine pregnancy or adnexal mass seen on ultrasound, follow-up will reveal that 65.5% had a failed intrauterine pregnancy, 33% had an ectopic pregnancy, and 1.5% had a viable intrauterine pregnancy.^3,10,11 If all of these 100 women had been treated with methotrexate for a presumed ectopic pregnancy, approximately two women with a viable intrauterine pregnancy would have been exposed to methotrexate. This exposure would likely result in either a pregnancy loss or, if the pregnancy continues, an increased risk of fetal anomalies.

If the patient is obese, has fibroids, or has adenomyosis, she has an increased risk of an ultrasound failing to detect an early intrauterine pregnancy when the hCG value ranges from 1,500 to 3,000 mIU/mL.¹² If the discriminatory zone is raised to 4,000 mIU/mL, the likelihood of mistakenly diagnosing a viable intrauterine pregnancy as a failed or ectopic pregnancy is much less (but not zero).

There is almost no clinical situation in which methotrexate should be given to a patient suspected of having an ectopic pregnancy on the first visit, unless ultrasound demonstrates an adnexal mass indicative of ectopic pregnancy.^13,14 If the patient has severe pain or bleeding, or has signs consistent with a ruptured ectopic pregnancy, surgical intervention likely is warranted. If the patient is clinically stable, a safe option is to repeat the hCG measurement in 48 hours, with an ultrasound if ­indicated.

The discriminatory zone is an interesting and elegant idea. But in practice it is fraught with serious dangers, the greatest of which is methotrexate administration to a patient with a viable intrauterine gestation. My advice is that gynecologists should stop relying on a discriminatory zone of 1,500 to 2,000 mIU/mL to trigger clinical intervention.  

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

Approximately 15% of early pregnancies are complicated by pelvic or abdominal pain and uterine bleeding or spotting. In these situations, you must determine whether your patient has a viable intrauterine pregnancy, a pregnancy that will end in a miscarriage (spontaneous abortion), or an ectopic pregnancy.

To guide you to the correct diagnosis, a medical history and physical examination can be helpful. For example, a woman with a prior ectopic pregnancy who now has an early pregnancy complicated by pelvic pain and uterine bleeding is at high risk for an ectopic pregnancy. Physical examination also is important; if the pelvic examination reveals a dilated cervix with pregnancy tissue in the cervical os it is likely that a miscarriage is in progress. For most cases of early pregnancy complicated by pelvic pain and/or uterine bleeding, however, a pelvic sonogram and serial quantitative ­measurement of ­human chorionic gonadotropin (hCG) are needed to achieve the correct diagnosis.

Here I outline the clinical markers for transvaginal ultrasonography that indicate a viable or failed intrauterine pregnancy as well as an ectopic pregnancy. I also present data on single vs serial hCG measurement and discuss serial hCG levels that indicate viable or nonviable intrauterine or ectopic ­pregnancy.

Is an early gestation viable? Clinical evaluationTransvaginal pelvic ultrasoundTransvaginal and transabdominal ultrasonography play a critical role in evaluating early pregnancy problems. In a normal pregnancy, key developmental milestones that can be observed reliably on ultrasound are^1,2:

A pelvic ultrasound also may provide evidence that an intra­uterine pregnancy will fail and result in a miscarriage. Findings diagnostic of a failed intrauterine pregnancy ­include³:

Findings suspicious for a failing intrauterine pregnancy include³:

When it’s an ectopic pregnancy. ­Definitive ultrasonographic evidence of an ectopic pregnancy is identification of a fetal heartbeat outside the uterus or a gestational sac and yolk sac outside of the uterus. An adnexal mass can be identified on ultrasonography in most cases of ectopic pregnancy. In one study of 291 ectopic pregnancies, an adnexal mass was identified in 94% of cases, and a moderate to large amount of free pelvic fluid was found in 36% of cases.⁴ The adnexal masses included nonspecific (54% of all ectopic cases), a tubal ring without a yolk sac or embryo (25%), a yolk sac but no embryonic heartbeat (8%), and an embryo with cardiac activity (7%).

In clinical units with high-­quality gynecologic ultrasonography available, most ectopic pregnancies will be detected on initial scan and only 10% to 15% of ectopic pregnancies will have an ultrasound finding of no intrauterine pregnancy and no evidence for an extrauterine pregnancy.⁵

Almost all (in the range of 99%) viable intrauterine pregnancies demonstrate an increase in hCG level of 53% or more over 48 hours, whereas only 21% of ectopic pregnancies demonstrate a rise of 53% or more.⁷

Most pregnancies that will end in a miscarriage demonstrate a decrease in hCG level over 48 hours. If the initial hCG value is 2,000 mIU/mL, 90% of pregnancies that will end in miscarriage will have an approximate 30% decrease in hCG over 48 hours. If the initial hCG is 1,000 mIU/mL, 95% of spontaneous abortions will have a 28% decline in 48 hours.⁷ About 10% of ectopic pregnancies also will demonstrate a 30% decrease in hCG over 48 hours.

A minor disadvantage of serial hCG measurements is that patients may become anxious and fearful as they await the result of life-altering test results.

When a gestation is found to be nonviable A viable intrauterine pregnancy is highly unlikely in a woman with no ultrasound evidence of an intrauterine pregnancy or an adnexal mass and an hCG level that rises very little, plateaus, or decreases over 48 hours. In this situation, a Karman cannula aspiration of uterine contents with rush pathology analysis can help clarify the likely diagnosis and guide therapy.

Women with documented ­villi on pathology likely are experiencing a miscarriage and can have their hCG level followed to resolution. Women with no documented villi and no decrease in hCG after the Karman
cannula aspiration can be presumed to have an ectopic pregnancy. If stable, these women may be candidates for treatment with methotrexate.^8,9

Many experts have counseled against the use of a single hCG measurement in the discriminatory zone of 1,500 to 2,000 mIU/mL to trigger methotrexate treatment. Here is a sampling of their advice:

“An hCG level of 2,000 mIU/mL, without ultrasound findings of intrauterine pregnancy, while suggestive of abnormal pregnancy, is not diagnostic. Per the results of recent studies, it is reasonable to closely follow up rather than treat many of these early, stable cases of ectopic pregnancy.”
                                                                                                                                                                    —Mehta et al.¹

“Our data demonstrate that using a single value of serum hCG in a pregnancy of unknown location (PUL) population is of limited value.... A significant proportion of failing PULs and early intrauterine pregnancies in a PUL population have high serum hCG levels at presentation.”
                                                                                                                                                                    —Condus et al.²

“The hCG discriminatory level should not be used to determine the management of a hemodynamically stable patient with suspected ectopic pregnancy, if sonography demonstrates no findings of intrauterine or ectopic pregnancy.”
                                                                                                                                                                    —Doubilet et al.³

“There is almost no reason to give methotrexate on first encounter with a patient. If a patient is symptomatic with severe pain or signs of rupture, a surgical approach is indicated and methotrexate is contraindicated.”
                                                                                                                                                                    —Barnhart et al.⁴

[When using the discriminatory zone]... “there is a chance of harming a viable intrauterine pregnancy, especially if the hCG level is 2000 to 3000 mIU/mL.... There is limited risk in taking a few extra days to make a definitive diagnosis in a woman with a pregnancy of unknown location who has no signs or symptoms of rupture and no ultrasonographic evidence of ectopic pregnancy.”
                                                                                                                                                                    —Doubliet et al.³

“Viable intrauterine pregnancy is possible in patients with pregnancy of unknown location and hCG levels above the generally accept discriminatory zone, strict adherence to which can potentially disrupt a normal pregnancy. We support the need for judicious use of the hCG discriminatory level in hemodynamically stable patients with pregnancy of unknown location, and the decision to intervene should not be based solely on a single hCG level.”
                                                                                                                                                                    —Ko and Cheung.⁵

References

Stop using the discriminatory zone and a single hCG measurement to trigger clinical intervention As noted above, a single hCG measurement is of very little value in determining whether an early pregnancy is a viable or nonviable intrauterine pregnancy or is ectopic. Many experts have reported that if a single hCG measurement shows a value of more than 1,500 mIU/mL and a pelvic ultrasound shows no intrauterine pregnancy, an ectopic or nonviable intrauterine pregnancy is likely. Some experts have used the presence of an hCG value of more  than 1,500 mIU/mL plus an ultrasound scan without evidence of an intrauterine pregnancy to clinically diagnose the absence of a viable intrauterine pregnancy and administer methotrexate to treat a presumptive ectopic pregnancy. Many experts believe, however, that this approach will necessarily result in the treatment of viable intrauterine pregnancies with methotrexate.^5,10

Based on one analysis, for 100 women with an initial hCG value between 2,000 and 3,000 mIU/mL and no intrauterine pregnancy or adnexal mass seen on ultrasound, follow-up will reveal that 65.5% had a failed intrauterine pregnancy, 33% had an ectopic pregnancy, and 1.5% had a viable intrauterine pregnancy.^3,10,11 If all of these 100 women had been treated with methotrexate for a presumed ectopic pregnancy, approximately two women with a viable intrauterine pregnancy would have been exposed to methotrexate. This exposure would likely result in either a pregnancy loss or, if the pregnancy continues, an increased risk of fetal anomalies.

If the patient is obese, has fibroids, or has adenomyosis, she has an increased risk of an ultrasound failing to detect an early intrauterine pregnancy when the hCG value ranges from 1,500 to 3,000 mIU/mL.¹² If the discriminatory zone is raised to 4,000 mIU/mL, the likelihood of mistakenly diagnosing a viable intrauterine pregnancy as a failed or ectopic pregnancy is much less (but not zero).

There is almost no clinical situation in which methotrexate should be given to a patient suspected of having an ectopic pregnancy on the first visit, unless ultrasound demonstrates an adnexal mass indicative of ectopic pregnancy.^13,14 If the patient has severe pain or bleeding, or has signs consistent with a ruptured ectopic pregnancy, surgical intervention likely is warranted. If the patient is clinically stable, a safe option is to repeat the hCG measurement in 48 hours, with an ultrasound if ­indicated.

The discriminatory zone is an interesting and elegant idea. But in practice it is fraught with serious dangers, the greatest of which is methotrexate administration to a patient with a viable intrauterine gestation. My advice is that gynecologists should stop relying on a discriminatory zone of 1,500 to 2,000 mIU/mL to trigger clinical intervention.  

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

With enactment of the Affordable Care Act (ACA) came a number of significant changes to federal and state Medicaid programs to increase ­access to care for low-income individuals. One landmark change, which became a state option after a ruling by the US Supreme Court, is the expansion of eligibility to all adults who have an income at or below 138% of the federal poverty line, which was $16,105 annually for an individual or $32,913 for a family of four in 2014.

Pregnancy is no longer a criterion for eligibility for low-income women in states with expanded Medicaid programs—a real game changer for millions of women in need of care.

As of this writing, 27 states, including the District of Columbia, have expanded their Medicaid program. Data from the Centers for Medicare and Medicaid Services (CMS) show that total enrollment in the Children’s Health Insurance Program (CHIP) and Medicaid increased by more than 4.8 million people (from 58.9 million to 63.7 million) between July 2013 and March 2014, in the 47 states reporting data for both periods. Nearly all of this growth occurred in Medicaid expansion states.^1,2 More recent data show that 7.9 million more people were enrolled in Medicaid in July 2014 than in the previous year.^3,4

Is Medicaid a losing proposition for ObGyns?
In many states, it costs ObGyns more than Medicaid pays to provide primary care to Medicaid patients. Nationally, providers receive 41% less in Medicaid reimbursement than they get with Medicare for primary care services.⁵ In 2012, the worst offender was Rhode Island’s Medicaid program, which paid physicians only 33% of the Medicare reimbursement rates for primary care.⁵

The rate of Medicaid reimbursement affects a physician’s willingness to accept new Medicaid patients. Only 50% of physicians are willing to accept new Medicaid patients, compared with 70% who are willing to accept new Medicare or privately insured patients. Twenty-three percent of female Medicaid beneficiaries report a problem finding a new doctor, compared with 7% of Medicare beneficiaries and 13% of privately insured women. The main reason: low Medicaid payment rates.⁶

In 2007, 38% of all ObGyns accepted Medicaid gynecology patients, and 44% accepted Medicaid obstetric patients, with Medicaid accounting for 18% of revenue for the average ObGyn practice. In its 2013 survey of members, ACOG found that while 63.2% accept all Medicare patients, only 44.4% accept all Medicaid gynecology patients, and 48.7% accept all Medicaid obstetric patients, up from 2007. The percentage of ObGyns who don’t see Medicaid gynecology or obstetric patients was 22.7% and 16.3%, respectively. Only 8.2% of ObGyns see no Medicare patients.⁷

According to a 2014 survey, 34% of physicians report an increase in Medicaid patients; 41% of those report an increase of 11% or more.³

The American Medical Association – The AMA considers the ­ObGyn specialty one of four specialties that provide primary care.

Tricare – The health-care program for uniformed service members (active, Guard/Reserve, retired) and their families around the world designates ObGyns as among primary care case managers.

Community Health Teams – A grant program to support primary care practices and patient-centered medical homes includes ObGyns as primary care providers.

Medicaid – Thirty-four states and the District of Columbia define ObGyns as primary care providers.

Medicaid Health Homes – Authorized under federal law to coordinate care for Medicaid enrollees with chronic conditions, health home providers coordinate all primary care, acute, behavioral health, and long-term services and supports to treat the whole person. ObGyns are eligible home health providers.

Health Resources Services Administration – This agency ­delineates health professional shortage areas, providing bonuses for physicians serving in these areas. It includes ObGyns as one of four primary care specialties.

National Health Service Corps – This organization offers loan repayments and scholarships to primary care providers working in underserved communities and recognizes ObGyns as primary care physicians.

Teaching Health Center Graduate Medical Education – This program supports community-based primary care residency programs to increase the number of primary care residents and dentists trained in geographically isolated or economically or medically vulnerable
communities.

Congress addresses the discrepancy
The ACA Medicaid primary care “bump,” as it’s called, was designed to help ensure access to primary care for the huge new group of individuals covered by Medicaid. It raised Medicaid payment rates for primary care services to Medicare fee levels in 2013 and 2014, an overall average increase of 73% in Medicaid payment rates for Evaluation and Management (E/M) codes 99201–99499, and for vaccine ­administration codes 90461 and 90471–90474 (FIGURES 1–3).⁸

The catch? The bump only applies to internists, family medicine physicians, and pediatricians. The House-passed bill included ObGyns—women’s primary care providers—but the Senate bill did not, and the Senate bill was the version ultimately enacted into law.

To qualify for these additional payments, physicians must self-attest to the state Medi­caid agency that she or he meets one of the following criteria:

For newly eligible physicians, the previous month’s billing is used to determine eligibility.

What about women’s health?
In speaking with ACOG Fellows, here’s what ACOG President John Jennings, MD, had to say about the omission of ObGyns from the primary care rate bump: 

ObGyns deliver primary and preventive care services to women; an ObGyn often is the only doctor a woman sees on a regular basis. Thirty-five state Medicaid programs classify ObGyns as primary care providers.⁹ Twelve percent of women aged 18 to 64 years rely on Medicaid for their health coverage, and more than 68% of adult Medicaid beneficiaries are women.¹⁰

Seeing an opportunity to expand the primary care reimbursement bump to include ObGyns, ACOG recently briefed Congress on the long and deep tradition of primary care in obstetrics and gynecology—a tradition that begins in residency. We provided Congress with ObGyn resident training requirements, as outlined by the Council on Resident Education in Obstetrics and Gynecology (CREOG).¹¹

How ObGyns provide primary care
According to CREOG, “ObGyns provide primary health-care services to their patients both within and outside the traditional purview of reproductive medicine. As primary care physicians, ObGyns establish relationships with their patients that transcend the disease spectrum and extend to routine assessments, preventive care, early intervention, and management of medical disorders.”¹¹

Among the services they provide are age-appropriate screening for substance use, sexual and reproductive health, sexually transmitted infection, psychosocial risks, breast disorders, cancer, and cardiovascular disease. ObGyns routinely counsel patients about diet, exercise, contraception, dental health, osteoporosis, and sexual health. And they provide front-line immunizations against such diseases as influenza, human papillomavirus, rubella, measles, meningitis, hepatitis A and B, and pneumonia.¹¹

Certification in obstetrics and gynecology requires written and oral examinations in office practice and women’s health as a primary care content area. In fact, fully one-third of the board certification test taken by 97% of the ObGyns in this country tests their knowledge and training in primary care.¹¹

How women view their ObGyn
A 2014 survey of women found that ObGyns play a critical role in providing primary care in the United States. Almost six in 10 women (58%) report that they see an ObGyn on a regular basis, and one-third of women (35%) view their ObGyn as their main source of care.¹²

Low-income women and women of color report that their ObGyn plays an even greater role in their health care. Latinas are far more likely (47%) to report that their ­ObGyn is their main source of care, compared with 35% of women overall. Sixty-four percent of African-American women say they see an ObGyn regularly, compared with 58% of women overall.¹²

Other survey findings:

ObGyns may see relief in 2015
Congress has before it legislation to extend the primary care bump program into the future and expand it to include ObGyns and other women’s health clinicians. A proposal to that effect was introduced in the Senate by Patty Murray (D-WA) and Sherrod Brown (D-OH) and in the House by Reps. Frank Pallone (D-NJ) and Henry Waxman (D-CA).

At press time, ACOG was doing everything in its power to get this legislation passed in the lame duck session of Congress. We scored a big win at the November assembly of the American Medical Association (AMA) House of Delegates, when, with the support of the American Academy of Pediatricians (AAP) and the American College of Physicians, the House of Delegates overwhelmingly approved AMA policy to support extension of the program, including broadening it to include ObGyns.

ACOG also has enlisted the support of national women’s advocacy groups, including Planned Parenthood, the National Partnership for Families and Children, and the National Women’s Law Center. ACOG President Jennings led 35 ACOG leaders from across the country to Washington, DC, in November 2014, to urge members of Congress to pass this important legislation. They were joined by Thomas McInerney, MD, immediate past president of the AAP, and a number of leaders from Planned Parenthood.

Our message to Congress is clear: Not without women!

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

With enactment of the Affordable Care Act (ACA) came a number of significant changes to federal and state Medicaid programs to increase ­access to care for low-income individuals. One landmark change, which became a state option after a ruling by the US Supreme Court, is the expansion of eligibility to all adults who have an income at or below 138% of the federal poverty line, which was $16,105 annually for an individual or $32,913 for a family of four in 2014.

Pregnancy is no longer a criterion for eligibility for low-income women in states with expanded Medicaid programs—a real game changer for millions of women in need of care.

As of this writing, 27 states, including the District of Columbia, have expanded their Medicaid program. Data from the Centers for Medicare and Medicaid Services (CMS) show that total enrollment in the Children’s Health Insurance Program (CHIP) and Medicaid increased by more than 4.8 million people (from 58.9 million to 63.7 million) between July 2013 and March 2014, in the 47 states reporting data for both periods. Nearly all of this growth occurred in Medicaid expansion states.^1,2 More recent data show that 7.9 million more people were enrolled in Medicaid in July 2014 than in the previous year.^3,4

Is Medicaid a losing proposition for ObGyns?
In many states, it costs ObGyns more than Medicaid pays to provide primary care to Medicaid patients. Nationally, providers receive 41% less in Medicaid reimbursement than they get with Medicare for primary care services.⁵ In 2012, the worst offender was Rhode Island’s Medicaid program, which paid physicians only 33% of the Medicare reimbursement rates for primary care.⁵

The rate of Medicaid reimbursement affects a physician’s willingness to accept new Medicaid patients. Only 50% of physicians are willing to accept new Medicaid patients, compared with 70% who are willing to accept new Medicare or privately insured patients. Twenty-three percent of female Medicaid beneficiaries report a problem finding a new doctor, compared with 7% of Medicare beneficiaries and 13% of privately insured women. The main reason: low Medicaid payment rates.⁶

In 2007, 38% of all ObGyns accepted Medicaid gynecology patients, and 44% accepted Medicaid obstetric patients, with Medicaid accounting for 18% of revenue for the average ObGyn practice. In its 2013 survey of members, ACOG found that while 63.2% accept all Medicare patients, only 44.4% accept all Medicaid gynecology patients, and 48.7% accept all Medicaid obstetric patients, up from 2007. The percentage of ObGyns who don’t see Medicaid gynecology or obstetric patients was 22.7% and 16.3%, respectively. Only 8.2% of ObGyns see no Medicare patients.⁷

According to a 2014 survey, 34% of physicians report an increase in Medicaid patients; 41% of those report an increase of 11% or more.³

The American Medical Association – The AMA considers the ­ObGyn specialty one of four specialties that provide primary care.

Tricare – The health-care program for uniformed service members (active, Guard/Reserve, retired) and their families around the world designates ObGyns as among primary care case managers.

Community Health Teams – A grant program to support primary care practices and patient-centered medical homes includes ObGyns as primary care providers.

Medicaid – Thirty-four states and the District of Columbia define ObGyns as primary care providers.

Medicaid Health Homes – Authorized under federal law to coordinate care for Medicaid enrollees with chronic conditions, health home providers coordinate all primary care, acute, behavioral health, and long-term services and supports to treat the whole person. ObGyns are eligible home health providers.

Health Resources Services Administration – This agency ­delineates health professional shortage areas, providing bonuses for physicians serving in these areas. It includes ObGyns as one of four primary care specialties.

National Health Service Corps – This organization offers loan repayments and scholarships to primary care providers working in underserved communities and recognizes ObGyns as primary care physicians.

Teaching Health Center Graduate Medical Education – This program supports community-based primary care residency programs to increase the number of primary care residents and dentists trained in geographically isolated or economically or medically vulnerable
communities.

Congress addresses the discrepancy
The ACA Medicaid primary care “bump,” as it’s called, was designed to help ensure access to primary care for the huge new group of individuals covered by Medicaid. It raised Medicaid payment rates for primary care services to Medicare fee levels in 2013 and 2014, an overall average increase of 73% in Medicaid payment rates for Evaluation and Management (E/M) codes 99201–99499, and for vaccine ­administration codes 90461 and 90471–90474 (FIGURES 1–3).⁸

The catch? The bump only applies to internists, family medicine physicians, and pediatricians. The House-passed bill included ObGyns—women’s primary care providers—but the Senate bill did not, and the Senate bill was the version ultimately enacted into law.

To qualify for these additional payments, physicians must self-attest to the state Medi­caid agency that she or he meets one of the following criteria:

For newly eligible physicians, the previous month’s billing is used to determine eligibility.

What about women’s health?
In speaking with ACOG Fellows, here’s what ACOG President John Jennings, MD, had to say about the omission of ObGyns from the primary care rate bump: 

ObGyns deliver primary and preventive care services to women; an ObGyn often is the only doctor a woman sees on a regular basis. Thirty-five state Medicaid programs classify ObGyns as primary care providers.⁹ Twelve percent of women aged 18 to 64 years rely on Medicaid for their health coverage, and more than 68% of adult Medicaid beneficiaries are women.¹⁰

Seeing an opportunity to expand the primary care reimbursement bump to include ObGyns, ACOG recently briefed Congress on the long and deep tradition of primary care in obstetrics and gynecology—a tradition that begins in residency. We provided Congress with ObGyn resident training requirements, as outlined by the Council on Resident Education in Obstetrics and Gynecology (CREOG).¹¹

How ObGyns provide primary care
According to CREOG, “ObGyns provide primary health-care services to their patients both within and outside the traditional purview of reproductive medicine. As primary care physicians, ObGyns establish relationships with their patients that transcend the disease spectrum and extend to routine assessments, preventive care, early intervention, and management of medical disorders.”¹¹

Among the services they provide are age-appropriate screening for substance use, sexual and reproductive health, sexually transmitted infection, psychosocial risks, breast disorders, cancer, and cardiovascular disease. ObGyns routinely counsel patients about diet, exercise, contraception, dental health, osteoporosis, and sexual health. And they provide front-line immunizations against such diseases as influenza, human papillomavirus, rubella, measles, meningitis, hepatitis A and B, and pneumonia.¹¹

Certification in obstetrics and gynecology requires written and oral examinations in office practice and women’s health as a primary care content area. In fact, fully one-third of the board certification test taken by 97% of the ObGyns in this country tests their knowledge and training in primary care.¹¹

How women view their ObGyn
A 2014 survey of women found that ObGyns play a critical role in providing primary care in the United States. Almost six in 10 women (58%) report that they see an ObGyn on a regular basis, and one-third of women (35%) view their ObGyn as their main source of care.¹²

Low-income women and women of color report that their ObGyn plays an even greater role in their health care. Latinas are far more likely (47%) to report that their ­ObGyn is their main source of care, compared with 35% of women overall. Sixty-four percent of African-American women say they see an ObGyn regularly, compared with 58% of women overall.¹²

Other survey findings:

ObGyns may see relief in 2015
Congress has before it legislation to extend the primary care bump program into the future and expand it to include ObGyns and other women’s health clinicians. A proposal to that effect was introduced in the Senate by Patty Murray (D-WA) and Sherrod Brown (D-OH) and in the House by Reps. Frank Pallone (D-NJ) and Henry Waxman (D-CA).

At press time, ACOG was doing everything in its power to get this legislation passed in the lame duck session of Congress. We scored a big win at the November assembly of the American Medical Association (AMA) House of Delegates, when, with the support of the American Academy of Pediatricians (AAP) and the American College of Physicians, the House of Delegates overwhelmingly approved AMA policy to support extension of the program, including broadening it to include ObGyns.

ACOG also has enlisted the support of national women’s advocacy groups, including Planned Parenthood, the National Partnership for Families and Children, and the National Women’s Law Center. ACOG President Jennings led 35 ACOG leaders from across the country to Washington, DC, in November 2014, to urge members of Congress to pass this important legislation. They were joined by Thomas McInerney, MD, immediate past president of the AAP, and a number of leaders from Planned Parenthood.

Our message to Congress is clear: Not without women!

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

With enactment of the Affordable Care Act (ACA) came a number of significant changes to federal and state Medicaid programs to increase ­access to care for low-income individuals. One landmark change, which became a state option after a ruling by the US Supreme Court, is the expansion of eligibility to all adults who have an income at or below 138% of the federal poverty line, which was $16,105 annually for an individual or $32,913 for a family of four in 2014.

Pregnancy is no longer a criterion for eligibility for low-income women in states with expanded Medicaid programs—a real game changer for millions of women in need of care.

As of this writing, 27 states, including the District of Columbia, have expanded their Medicaid program. Data from the Centers for Medicare and Medicaid Services (CMS) show that total enrollment in the Children’s Health Insurance Program (CHIP) and Medicaid increased by more than 4.8 million people (from 58.9 million to 63.7 million) between July 2013 and March 2014, in the 47 states reporting data for both periods. Nearly all of this growth occurred in Medicaid expansion states.^1,2 More recent data show that 7.9 million more people were enrolled in Medicaid in July 2014 than in the previous year.^3,4

Is Medicaid a losing proposition for ObGyns?
In many states, it costs ObGyns more than Medicaid pays to provide primary care to Medicaid patients. Nationally, providers receive 41% less in Medicaid reimbursement than they get with Medicare for primary care services.⁵ In 2012, the worst offender was Rhode Island’s Medicaid program, which paid physicians only 33% of the Medicare reimbursement rates for primary care.⁵

The rate of Medicaid reimbursement affects a physician’s willingness to accept new Medicaid patients. Only 50% of physicians are willing to accept new Medicaid patients, compared with 70% who are willing to accept new Medicare or privately insured patients. Twenty-three percent of female Medicaid beneficiaries report a problem finding a new doctor, compared with 7% of Medicare beneficiaries and 13% of privately insured women. The main reason: low Medicaid payment rates.⁶

In 2007, 38% of all ObGyns accepted Medicaid gynecology patients, and 44% accepted Medicaid obstetric patients, with Medicaid accounting for 18% of revenue for the average ObGyn practice. In its 2013 survey of members, ACOG found that while 63.2% accept all Medicare patients, only 44.4% accept all Medicaid gynecology patients, and 48.7% accept all Medicaid obstetric patients, up from 2007. The percentage of ObGyns who don’t see Medicaid gynecology or obstetric patients was 22.7% and 16.3%, respectively. Only 8.2% of ObGyns see no Medicare patients.⁷

According to a 2014 survey, 34% of physicians report an increase in Medicaid patients; 41% of those report an increase of 11% or more.³

The American Medical Association – The AMA considers the ­ObGyn specialty one of four specialties that provide primary care.

Tricare – The health-care program for uniformed service members (active, Guard/Reserve, retired) and their families around the world designates ObGyns as among primary care case managers.

Community Health Teams – A grant program to support primary care practices and patient-centered medical homes includes ObGyns as primary care providers.

Medicaid – Thirty-four states and the District of Columbia define ObGyns as primary care providers.

Medicaid Health Homes – Authorized under federal law to coordinate care for Medicaid enrollees with chronic conditions, health home providers coordinate all primary care, acute, behavioral health, and long-term services and supports to treat the whole person. ObGyns are eligible home health providers.

Health Resources Services Administration – This agency ­delineates health professional shortage areas, providing bonuses for physicians serving in these areas. It includes ObGyns as one of four primary care specialties.

National Health Service Corps – This organization offers loan repayments and scholarships to primary care providers working in underserved communities and recognizes ObGyns as primary care physicians.

Teaching Health Center Graduate Medical Education – This program supports community-based primary care residency programs to increase the number of primary care residents and dentists trained in geographically isolated or economically or medically vulnerable
communities.

Congress addresses the discrepancy
The ACA Medicaid primary care “bump,” as it’s called, was designed to help ensure access to primary care for the huge new group of individuals covered by Medicaid. It raised Medicaid payment rates for primary care services to Medicare fee levels in 2013 and 2014, an overall average increase of 73% in Medicaid payment rates for Evaluation and Management (E/M) codes 99201–99499, and for vaccine ­administration codes 90461 and 90471–90474 (FIGURES 1–3).⁸

The catch? The bump only applies to internists, family medicine physicians, and pediatricians. The House-passed bill included ObGyns—women’s primary care providers—but the Senate bill did not, and the Senate bill was the version ultimately enacted into law.

To qualify for these additional payments, physicians must self-attest to the state Medi­caid agency that she or he meets one of the following criteria:

For newly eligible physicians, the previous month’s billing is used to determine eligibility.

What about women’s health?
In speaking with ACOG Fellows, here’s what ACOG President John Jennings, MD, had to say about the omission of ObGyns from the primary care rate bump: 

ObGyns deliver primary and preventive care services to women; an ObGyn often is the only doctor a woman sees on a regular basis. Thirty-five state Medicaid programs classify ObGyns as primary care providers.⁹ Twelve percent of women aged 18 to 64 years rely on Medicaid for their health coverage, and more than 68% of adult Medicaid beneficiaries are women.¹⁰

Seeing an opportunity to expand the primary care reimbursement bump to include ObGyns, ACOG recently briefed Congress on the long and deep tradition of primary care in obstetrics and gynecology—a tradition that begins in residency. We provided Congress with ObGyn resident training requirements, as outlined by the Council on Resident Education in Obstetrics and Gynecology (CREOG).¹¹

How ObGyns provide primary care
According to CREOG, “ObGyns provide primary health-care services to their patients both within and outside the traditional purview of reproductive medicine. As primary care physicians, ObGyns establish relationships with their patients that transcend the disease spectrum and extend to routine assessments, preventive care, early intervention, and management of medical disorders.”¹¹

Among the services they provide are age-appropriate screening for substance use, sexual and reproductive health, sexually transmitted infection, psychosocial risks, breast disorders, cancer, and cardiovascular disease. ObGyns routinely counsel patients about diet, exercise, contraception, dental health, osteoporosis, and sexual health. And they provide front-line immunizations against such diseases as influenza, human papillomavirus, rubella, measles, meningitis, hepatitis A and B, and pneumonia.¹¹

Certification in obstetrics and gynecology requires written and oral examinations in office practice and women’s health as a primary care content area. In fact, fully one-third of the board certification test taken by 97% of the ObGyns in this country tests their knowledge and training in primary care.¹¹

How women view their ObGyn
A 2014 survey of women found that ObGyns play a critical role in providing primary care in the United States. Almost six in 10 women (58%) report that they see an ObGyn on a regular basis, and one-third of women (35%) view their ObGyn as their main source of care.¹²

Low-income women and women of color report that their ObGyn plays an even greater role in their health care. Latinas are far more likely (47%) to report that their ­ObGyn is their main source of care, compared with 35% of women overall. Sixty-four percent of African-American women say they see an ObGyn regularly, compared with 58% of women overall.¹²

Other survey findings:

ObGyns may see relief in 2015
Congress has before it legislation to extend the primary care bump program into the future and expand it to include ObGyns and other women’s health clinicians. A proposal to that effect was introduced in the Senate by Patty Murray (D-WA) and Sherrod Brown (D-OH) and in the House by Reps. Frank Pallone (D-NJ) and Henry Waxman (D-CA).

At press time, ACOG was doing everything in its power to get this legislation passed in the lame duck session of Congress. We scored a big win at the November assembly of the American Medical Association (AMA) House of Delegates, when, with the support of the American Academy of Pediatricians (AAP) and the American College of Physicians, the House of Delegates overwhelmingly approved AMA policy to support extension of the program, including broadening it to include ObGyns.

ACOG also has enlisted the support of national women’s advocacy groups, including Planned Parenthood, the National Partnership for Families and Children, and the National Women’s Law Center. ACOG President Jennings led 35 ACOG leaders from across the country to Washington, DC, in November 2014, to urge members of Congress to pass this important legislation. They were joined by Thomas McInerney, MD, immediate past president of the AAP, and a number of leaders from Planned Parenthood.

Our message to Congress is clear: Not without women!

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

Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?

Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.

Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.

Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and ­invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.

Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.

Although multiple biopsies increased the diagnostic yield in all groups, the ­greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.

What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-­appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
                                                                                                                                                       —Andrew M. Kaunitz, MD

How useful is random biopsy when no lesions are seen?

Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.

Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.

When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?

Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.

Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.

Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.

What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Went­sensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
                                                                                                                                                      —Andrew M. Kaunitz, MD

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

Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?

Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.

Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.

Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and ­invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.

Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.

Although multiple biopsies increased the diagnostic yield in all groups, the ­greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.

What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-­appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
                                                                                                                                                       —Andrew M. Kaunitz, MD

How useful is random biopsy when no lesions are seen?

Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.

Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.

When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?

Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.

Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.

Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.

What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Went­sensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
                                                                                                                                                      —Andrew M. Kaunitz, MD

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

Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?

Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.

Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.

Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and ­invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.

Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.

Although multiple biopsies increased the diagnostic yield in all groups, the ­greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.

What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-­appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
                                                                                                                                                       —Andrew M. Kaunitz, MD

How useful is random biopsy when no lesions are seen?

Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.

Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.

When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?

Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.

Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.

Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.

What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Went­sensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
                                                                                                                                                      —Andrew M. Kaunitz, MD

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