Expert Commentary

Evidence-based education about long-acting reversible contraception (LARC) for women in the postpartum period can result in the increased continuation of and satisfaction with LARC.¹ However, nearly 40% of women do not attend a postpartum visit.² And up to 57% of women report having unprotected intercourse before the 6-week postpartum visit, which increases the risk of unplanned pregnancy.³ The American College of Obstetricians and Gynecologists (ACOG) supports immediate postpartum LARC insertion as best practice,³ and clinicians providing care for women during the peripartum period can counsel women regarding informed contraceptive decisions and provide guidance regarding both short-acting contraception and LARC.¹ 

Immediate postpartum LARC, using intrauterine devices (IUDs) in particular, has been used around the world for a long time, says Lisa Hofler, MD, MPH, MBA, Chief in the Division of Family Planning at the University of New Mexico School of Medicine in Albuquerque. “Much of our initial data came from other countries, but eventually people in the United States said, ‘This is a great option, why aren't we doing this?’" In addition, although women considering immediate postpartum LARC should be counseled about the theoretical risk of reduced duration of breastfeeding, the evidence overwhelmingly has not shown a negative effect on actual breastfeeding outcomes according to ACOG.³ OBG MANAGEMENT recently met up with Dr. Hofler to ask her which patients are ideal for postpartum LARC, how to troubleshoot common pitfalls, and how to implement the practice within one’s own institution. 

OBG Management: Who do you consider to be the ideal patient for immediate postpartum LARC? 

Lisa Hofler, MD: The great thing about immediate postpartum LARC (including IUDs and implants) is that any woman is an ideal candidate. We are simply talking about the timing of when a woman chooses to get an IUD or an implant after the birth of her child. There is no one perfect woman; it is the person who chooses the method and wants to use that method immediately after birth. When a woman chooses a LARC, she can be assured that after the birth of her child she will be protected against pregnancy. If she chooses an IUD as her LARC method, she will be comfortable at insertion because the cervix is already dilated when it is inserted.

For the implant, the contraindications are the same as in the outpatient setting. The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use covers many medical conditions and whether or not a person might be a candidate for different birth control methods.⁴ Those same considerations apply for the implant postpartum (TABLE).³

For the IUD, similarly, anyone who would not be a candidate for the IUD in the outpatient setting is not a candidate for immediate postpartum IUD. For instance, if the person has an intrauterine infection, you should not place an IUD. Also, if a patient is hemorrhaging and you are managing the hemorrhage (say she has retained placenta or membranes or she has uterine atony), you are not going to put an IUD in, as you need to attend to her bleeding.

OBG Management: What is your approach to counseling a patient for immediate postpartum LARC?

Dr. Hofler: The ideal time to counsel about postbirth contraception is in the prenatal period, when the patient is making decisions about what method she wants to use after the birth. Once she chooses her preferred method, address timing if appropriate. It is less ideal to talk to a woman about the option of immediate postpartum LARC when she comes to labor and delivery, especially if that is the first time she has heard about it. Certainly, the time to talk about postpartum LARC options is not immediately after the baby is born. Approaching your patient with, "What do you want for birth control? Do you want this IUD? I can put it in right now," can feel coercive. This approach does not put the woman in a position in which she has enough decision-making time or time to ask questions. 

OBG Management: What problems do clinicians run into when placing an immediate postpartum IUD, and can you offer solutions?

Dr. Hofler: When placing an immediate postpartum IUD, people might run into a few problems. The first relates to preplacement counseling. Perhaps when making the plan for the postpartum IUD the clinician did not counsel the woman that there are certain conditions that could preclude IUD placement—such as intrauterine infection or postpartum hemorrhage. When dealing with those types of issues, a patient is not eligible for an IUD, and she should be mentally prepared for this type of situation. Let her know during the counseling before the birth that immediately postpartum is a great time and opportunity for effective contraception placement. Tell her that hopefully IUD placement will be possible but that occasionally it is not, and make a back-up plan in case the IUD cannot be placed immediately postpartum. 

The second unique area for counseling with immediate postpartum IUDs is a slightly increased risk of expulsion of an IUD placed immediately postpartum compared with in the office. The risk of expulsion varies by type of delivery. For instance, cesarean delivery births have a lower expulsion rate than vaginal births. The expulsion rate seems to vary by type of IUD as well. Copper IUDs seem to have a slightly lower expulsion rate than hormonal IUDs. (See “Levonorgestrel vs copper IUD expulsion rates after immediate postpartum insertion.”) This consideration should be talked about ahead of time, too. Provider training in IUD placement does impact the likelihood of expulsion, and if you place the IUD at the fundus, it is less likely to expel. (See “Inserting the immediate postpartum IUD after vaginal and cesarean birth step by step.”)

A third issue that clinicians run into is actually the systems of care—making sure that the IUD or implant is available when you need it, making sure that documentation happens the way it should, and ensuring that the follow-up billing and revenue cycle happens so that the woman gets the device that she wants and the providers get paid for having provided it. These issues require a multidisciplinary team to work through in order to ensure that postpartum LARC placement is a sustainable process in the long run. 

Often, when people think of immediate postpartum LARC they think of postplacental IUDs. However, an implant also is an option, and that too is immediate postpartum LARC. Placing an implant is often a lot easier to do after the birth than placing an IUD. As clinicians work toward bringing an immediate postpartum LARC program to their hospital system, starting with implants is a smart thing to do because clinicians do not have to learn or teach new clinical skills. Because of that, immediate postpartum implants are a good troubleshooting mechanism for opening up the conversation about immediate postpartum LARC at your institution.

OBG MANAGEMENT: What advice do you have for administrators or physicians looking to implement an immediate postpartum LARC program into a hospital setting?

Dr. Hofler: Probably the best single resource is the American College of Obstetricians and Gynecologists’ Postpartum Contraception Access Initiative (PCAI). They have a dedicated website and offer a lot of support and resources that include site-specific training at the hospital or the institution; clinician training on implants and IUDs; and administrator training on some of the systems of care, the billing process, the stocking process, and pharmacy education. They also provide information on all the things that should be included beyond the clinical aspects. I strongly recommend looking at what they offer. 

Also, because many hospitals say, "We love this idea. We would support immediate postpartum LARC, we just want to make sure we get paid," the ACOG LARC Program website includes state-specific guidance for how Medicaid pays for LARC devices. There is state-specific guidance about how the device payment can be separated from the global payment for delivery—specific things for each institution to do to get reimbursed. 

Evidence-based education about long-acting reversible contraception (LARC) for women in the postpartum period can result in the increased continuation of and satisfaction with LARC.¹ However, nearly 40% of women do not attend a postpartum visit.² And up to 57% of women report having unprotected intercourse before the 6-week postpartum visit, which increases the risk of unplanned pregnancy.³ The American College of Obstetricians and Gynecologists (ACOG) supports immediate postpartum LARC insertion as best practice,³ and clinicians providing care for women during the peripartum period can counsel women regarding informed contraceptive decisions and provide guidance regarding both short-acting contraception and LARC.¹ 

Immediate postpartum LARC, using intrauterine devices (IUDs) in particular, has been used around the world for a long time, says Lisa Hofler, MD, MPH, MBA, Chief in the Division of Family Planning at the University of New Mexico School of Medicine in Albuquerque. “Much of our initial data came from other countries, but eventually people in the United States said, ‘This is a great option, why aren't we doing this?’" In addition, although women considering immediate postpartum LARC should be counseled about the theoretical risk of reduced duration of breastfeeding, the evidence overwhelmingly has not shown a negative effect on actual breastfeeding outcomes according to ACOG.³ OBG MANAGEMENT recently met up with Dr. Hofler to ask her which patients are ideal for postpartum LARC, how to troubleshoot common pitfalls, and how to implement the practice within one’s own institution. 

OBG Management: Who do you consider to be the ideal patient for immediate postpartum LARC? 

Lisa Hofler, MD: The great thing about immediate postpartum LARC (including IUDs and implants) is that any woman is an ideal candidate. We are simply talking about the timing of when a woman chooses to get an IUD or an implant after the birth of her child. There is no one perfect woman; it is the person who chooses the method and wants to use that method immediately after birth. When a woman chooses a LARC, she can be assured that after the birth of her child she will be protected against pregnancy. If she chooses an IUD as her LARC method, she will be comfortable at insertion because the cervix is already dilated when it is inserted.

For the implant, the contraindications are the same as in the outpatient setting. The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use covers many medical conditions and whether or not a person might be a candidate for different birth control methods.⁴ Those same considerations apply for the implant postpartum (TABLE).³

For the IUD, similarly, anyone who would not be a candidate for the IUD in the outpatient setting is not a candidate for immediate postpartum IUD. For instance, if the person has an intrauterine infection, you should not place an IUD. Also, if a patient is hemorrhaging and you are managing the hemorrhage (say she has retained placenta or membranes or she has uterine atony), you are not going to put an IUD in, as you need to attend to her bleeding.

OBG Management: What is your approach to counseling a patient for immediate postpartum LARC?

Dr. Hofler: The ideal time to counsel about postbirth contraception is in the prenatal period, when the patient is making decisions about what method she wants to use after the birth. Once she chooses her preferred method, address timing if appropriate. It is less ideal to talk to a woman about the option of immediate postpartum LARC when she comes to labor and delivery, especially if that is the first time she has heard about it. Certainly, the time to talk about postpartum LARC options is not immediately after the baby is born. Approaching your patient with, "What do you want for birth control? Do you want this IUD? I can put it in right now," can feel coercive. This approach does not put the woman in a position in which she has enough decision-making time or time to ask questions. 

OBG Management: What problems do clinicians run into when placing an immediate postpartum IUD, and can you offer solutions?

Dr. Hofler: When placing an immediate postpartum IUD, people might run into a few problems. The first relates to preplacement counseling. Perhaps when making the plan for the postpartum IUD the clinician did not counsel the woman that there are certain conditions that could preclude IUD placement—such as intrauterine infection or postpartum hemorrhage. When dealing with those types of issues, a patient is not eligible for an IUD, and she should be mentally prepared for this type of situation. Let her know during the counseling before the birth that immediately postpartum is a great time and opportunity for effective contraception placement. Tell her that hopefully IUD placement will be possible but that occasionally it is not, and make a back-up plan in case the IUD cannot be placed immediately postpartum. 

The second unique area for counseling with immediate postpartum IUDs is a slightly increased risk of expulsion of an IUD placed immediately postpartum compared with in the office. The risk of expulsion varies by type of delivery. For instance, cesarean delivery births have a lower expulsion rate than vaginal births. The expulsion rate seems to vary by type of IUD as well. Copper IUDs seem to have a slightly lower expulsion rate than hormonal IUDs. (See “Levonorgestrel vs copper IUD expulsion rates after immediate postpartum insertion.”) This consideration should be talked about ahead of time, too. Provider training in IUD placement does impact the likelihood of expulsion, and if you place the IUD at the fundus, it is less likely to expel. (See “Inserting the immediate postpartum IUD after vaginal and cesarean birth step by step.”)

A third issue that clinicians run into is actually the systems of care—making sure that the IUD or implant is available when you need it, making sure that documentation happens the way it should, and ensuring that the follow-up billing and revenue cycle happens so that the woman gets the device that she wants and the providers get paid for having provided it. These issues require a multidisciplinary team to work through in order to ensure that postpartum LARC placement is a sustainable process in the long run. 

Often, when people think of immediate postpartum LARC they think of postplacental IUDs. However, an implant also is an option, and that too is immediate postpartum LARC. Placing an implant is often a lot easier to do after the birth than placing an IUD. As clinicians work toward bringing an immediate postpartum LARC program to their hospital system, starting with implants is a smart thing to do because clinicians do not have to learn or teach new clinical skills. Because of that, immediate postpartum implants are a good troubleshooting mechanism for opening up the conversation about immediate postpartum LARC at your institution.

OBG MANAGEMENT: What advice do you have for administrators or physicians looking to implement an immediate postpartum LARC program into a hospital setting?

Dr. Hofler: Probably the best single resource is the American College of Obstetricians and Gynecologists’ Postpartum Contraception Access Initiative (PCAI). They have a dedicated website and offer a lot of support and resources that include site-specific training at the hospital or the institution; clinician training on implants and IUDs; and administrator training on some of the systems of care, the billing process, the stocking process, and pharmacy education. They also provide information on all the things that should be included beyond the clinical aspects. I strongly recommend looking at what they offer. 

Also, because many hospitals say, "We love this idea. We would support immediate postpartum LARC, we just want to make sure we get paid," the ACOG LARC Program website includes state-specific guidance for how Medicaid pays for LARC devices. There is state-specific guidance about how the device payment can be separated from the global payment for delivery—specific things for each institution to do to get reimbursed. 

Evidence-based education about long-acting reversible contraception (LARC) for women in the postpartum period can result in the increased continuation of and satisfaction with LARC.¹ However, nearly 40% of women do not attend a postpartum visit.² And up to 57% of women report having unprotected intercourse before the 6-week postpartum visit, which increases the risk of unplanned pregnancy.³ The American College of Obstetricians and Gynecologists (ACOG) supports immediate postpartum LARC insertion as best practice,³ and clinicians providing care for women during the peripartum period can counsel women regarding informed contraceptive decisions and provide guidance regarding both short-acting contraception and LARC.¹ 

Immediate postpartum LARC, using intrauterine devices (IUDs) in particular, has been used around the world for a long time, says Lisa Hofler, MD, MPH, MBA, Chief in the Division of Family Planning at the University of New Mexico School of Medicine in Albuquerque. “Much of our initial data came from other countries, but eventually people in the United States said, ‘This is a great option, why aren't we doing this?’" In addition, although women considering immediate postpartum LARC should be counseled about the theoretical risk of reduced duration of breastfeeding, the evidence overwhelmingly has not shown a negative effect on actual breastfeeding outcomes according to ACOG.³ OBG MANAGEMENT recently met up with Dr. Hofler to ask her which patients are ideal for postpartum LARC, how to troubleshoot common pitfalls, and how to implement the practice within one’s own institution. 

OBG Management: Who do you consider to be the ideal patient for immediate postpartum LARC? 

Lisa Hofler, MD: The great thing about immediate postpartum LARC (including IUDs and implants) is that any woman is an ideal candidate. We are simply talking about the timing of when a woman chooses to get an IUD or an implant after the birth of her child. There is no one perfect woman; it is the person who chooses the method and wants to use that method immediately after birth. When a woman chooses a LARC, she can be assured that after the birth of her child she will be protected against pregnancy. If she chooses an IUD as her LARC method, she will be comfortable at insertion because the cervix is already dilated when it is inserted.

For the implant, the contraindications are the same as in the outpatient setting. The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use covers many medical conditions and whether or not a person might be a candidate for different birth control methods.⁴ Those same considerations apply for the implant postpartum (TABLE).³

For the IUD, similarly, anyone who would not be a candidate for the IUD in the outpatient setting is not a candidate for immediate postpartum IUD. For instance, if the person has an intrauterine infection, you should not place an IUD. Also, if a patient is hemorrhaging and you are managing the hemorrhage (say she has retained placenta or membranes or she has uterine atony), you are not going to put an IUD in, as you need to attend to her bleeding.

OBG Management: What is your approach to counseling a patient for immediate postpartum LARC?

Dr. Hofler: The ideal time to counsel about postbirth contraception is in the prenatal period, when the patient is making decisions about what method she wants to use after the birth. Once she chooses her preferred method, address timing if appropriate. It is less ideal to talk to a woman about the option of immediate postpartum LARC when she comes to labor and delivery, especially if that is the first time she has heard about it. Certainly, the time to talk about postpartum LARC options is not immediately after the baby is born. Approaching your patient with, "What do you want for birth control? Do you want this IUD? I can put it in right now," can feel coercive. This approach does not put the woman in a position in which she has enough decision-making time or time to ask questions. 

OBG Management: What problems do clinicians run into when placing an immediate postpartum IUD, and can you offer solutions?

Dr. Hofler: When placing an immediate postpartum IUD, people might run into a few problems. The first relates to preplacement counseling. Perhaps when making the plan for the postpartum IUD the clinician did not counsel the woman that there are certain conditions that could preclude IUD placement—such as intrauterine infection or postpartum hemorrhage. When dealing with those types of issues, a patient is not eligible for an IUD, and she should be mentally prepared for this type of situation. Let her know during the counseling before the birth that immediately postpartum is a great time and opportunity for effective contraception placement. Tell her that hopefully IUD placement will be possible but that occasionally it is not, and make a back-up plan in case the IUD cannot be placed immediately postpartum. 

The second unique area for counseling with immediate postpartum IUDs is a slightly increased risk of expulsion of an IUD placed immediately postpartum compared with in the office. The risk of expulsion varies by type of delivery. For instance, cesarean delivery births have a lower expulsion rate than vaginal births. The expulsion rate seems to vary by type of IUD as well. Copper IUDs seem to have a slightly lower expulsion rate than hormonal IUDs. (See “Levonorgestrel vs copper IUD expulsion rates after immediate postpartum insertion.”) This consideration should be talked about ahead of time, too. Provider training in IUD placement does impact the likelihood of expulsion, and if you place the IUD at the fundus, it is less likely to expel. (See “Inserting the immediate postpartum IUD after vaginal and cesarean birth step by step.”)

A third issue that clinicians run into is actually the systems of care—making sure that the IUD or implant is available when you need it, making sure that documentation happens the way it should, and ensuring that the follow-up billing and revenue cycle happens so that the woman gets the device that she wants and the providers get paid for having provided it. These issues require a multidisciplinary team to work through in order to ensure that postpartum LARC placement is a sustainable process in the long run. 

Often, when people think of immediate postpartum LARC they think of postplacental IUDs. However, an implant also is an option, and that too is immediate postpartum LARC. Placing an implant is often a lot easier to do after the birth than placing an IUD. As clinicians work toward bringing an immediate postpartum LARC program to their hospital system, starting with implants is a smart thing to do because clinicians do not have to learn or teach new clinical skills. Because of that, immediate postpartum implants are a good troubleshooting mechanism for opening up the conversation about immediate postpartum LARC at your institution.

OBG MANAGEMENT: What advice do you have for administrators or physicians looking to implement an immediate postpartum LARC program into a hospital setting?

Dr. Hofler: Probably the best single resource is the American College of Obstetricians and Gynecologists’ Postpartum Contraception Access Initiative (PCAI). They have a dedicated website and offer a lot of support and resources that include site-specific training at the hospital or the institution; clinician training on implants and IUDs; and administrator training on some of the systems of care, the billing process, the stocking process, and pharmacy education. They also provide information on all the things that should be included beyond the clinical aspects. I strongly recommend looking at what they offer. 

Also, because many hospitals say, "We love this idea. We would support immediate postpartum LARC, we just want to make sure we get paid," the ACOG LARC Program website includes state-specific guidance for how Medicaid pays for LARC devices. There is state-specific guidance about how the device payment can be separated from the global payment for delivery—specific things for each institution to do to get reimbursed. 

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

Zwertbroek EF, Franssen MT, Broekhuijsen K, et al; HYPITAT-II Study Group. Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring of mild hypertensive disorders of pregnancy: 2-year outcomes of the HYPITAT-II trial. Am J Obstet Gynecol. doi:10.1016/j.ajog.2019.03.024.

EXPERT COMMENTARY

In women with mild hypertensive disorders in the preterm period, the maternal benefits of delivery should be weighed against the consequences of preterm birth for the neonate. In a recent study, Zwertbroek and colleagues sought to evaluate the long-term neurodevelopmental effects of this decision on the offspring.

Details of the study

The authors conducted a follow-up study of the randomized, controlled Hypertension and Preeclampsia Intervention Trial At Term II (HYPITAT-II), in which 704 women diagnosed with late preterm (34–37 weeks) hypertensive disorders in pregnancy (gestational hypertension, chronic hypertension, or mild preeclampsia) were randomly assigned to immediate delivery or expectant management.

Expectant management consisted of close monitoring until 37 weeks or until an indication for delivery occurred, whichever came first. Children born to those mothers were eligible for this study (women enrolled during 2011–2015) when they reached 2 years of age; 342 children were included in this analysis. Of note, children from the expectant management group had been delivered at a more advanced gestational age (median, 37.0 vs 36.1 weeks; P<.001) than those in the immediate-delivery group.

Survey tools. Parents completed 2 response surveys, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL), between 23 and 26 months’ corrected age. The ASQ is designed to detect developmental delay, while the CBCL assesses behavioral and emotional problems. The primary outcome was an abnormal result on either screen.

Results. Based on 330 returned questionnaires, the authors found more abnormal ASQ scores (45 of 162 [28%] vs 27 of 148 [18%] children; P = .045) in the immediate-delivery group versus the expectant management group, most pronounced in the fine motor domain. They found no difference in the CBCL scores. The authors concluded that immediate delivery for women with late preterm mild hypertensive disorders in pregnancy increases the risk of developmental delay in the children.

Study strengths and limitations

This study is unique as a planned follow-up to a randomized, controlled trial, allowing for 2-year outcomes to be assessed on children of enrolled women with mild hypertensive disorders in the late preterm period. The authors used validated surveys that are known to predict long-term neurodevelopmental outcomes.

Continue to: This work has several limitations...

This work has several limitations, however. Randomization was not truly maintained given the less than 50% response rate of original participants. Additionally, parents completed the surveys and provider confirmation of developmental concerns or diagnoses was not obtained. Further, assessments at 2 years of age may be too early to detect subtle differences, with evaluations at 5 years more predictive of long-term outcomes; the authors stated that these data already are being collected.

Finally, while these data importantly reinforce the conclusions of the parent HYPITAT-II trial, which support expectant management for mild hypertensive disorders in the late preterm period,¹ clinicians must always take care to individualize decisions in the face of worsening maternal disease.

Zwertbroek EF, Franssen MT, Broekhuijsen K, et al; HYPITAT-II Study Group. Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring of mild hypertensive disorders of pregnancy: 2-year outcomes of the HYPITAT-II trial. Am J Obstet Gynecol. doi:10.1016/j.ajog.2019.03.024.

EXPERT COMMENTARY

In women with mild hypertensive disorders in the preterm period, the maternal benefits of delivery should be weighed against the consequences of preterm birth for the neonate. In a recent study, Zwertbroek and colleagues sought to evaluate the long-term neurodevelopmental effects of this decision on the offspring.

Details of the study

The authors conducted a follow-up study of the randomized, controlled Hypertension and Preeclampsia Intervention Trial At Term II (HYPITAT-II), in which 704 women diagnosed with late preterm (34–37 weeks) hypertensive disorders in pregnancy (gestational hypertension, chronic hypertension, or mild preeclampsia) were randomly assigned to immediate delivery or expectant management.

Expectant management consisted of close monitoring until 37 weeks or until an indication for delivery occurred, whichever came first. Children born to those mothers were eligible for this study (women enrolled during 2011–2015) when they reached 2 years of age; 342 children were included in this analysis. Of note, children from the expectant management group had been delivered at a more advanced gestational age (median, 37.0 vs 36.1 weeks; P<.001) than those in the immediate-delivery group.

Survey tools. Parents completed 2 response surveys, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL), between 23 and 26 months’ corrected age. The ASQ is designed to detect developmental delay, while the CBCL assesses behavioral and emotional problems. The primary outcome was an abnormal result on either screen.

Results. Based on 330 returned questionnaires, the authors found more abnormal ASQ scores (45 of 162 [28%] vs 27 of 148 [18%] children; P = .045) in the immediate-delivery group versus the expectant management group, most pronounced in the fine motor domain. They found no difference in the CBCL scores. The authors concluded that immediate delivery for women with late preterm mild hypertensive disorders in pregnancy increases the risk of developmental delay in the children.

Study strengths and limitations

This study is unique as a planned follow-up to a randomized, controlled trial, allowing for 2-year outcomes to be assessed on children of enrolled women with mild hypertensive disorders in the late preterm period. The authors used validated surveys that are known to predict long-term neurodevelopmental outcomes.

Continue to: This work has several limitations...

This work has several limitations, however. Randomization was not truly maintained given the less than 50% response rate of original participants. Additionally, parents completed the surveys and provider confirmation of developmental concerns or diagnoses was not obtained. Further, assessments at 2 years of age may be too early to detect subtle differences, with evaluations at 5 years more predictive of long-term outcomes; the authors stated that these data already are being collected.

Finally, while these data importantly reinforce the conclusions of the parent HYPITAT-II trial, which support expectant management for mild hypertensive disorders in the late preterm period,¹ clinicians must always take care to individualize decisions in the face of worsening maternal disease.

Zwertbroek EF, Franssen MT, Broekhuijsen K, et al; HYPITAT-II Study Group. Neonatal developmental and behavioral outcomes of immediate delivery versus expectant monitoring of mild hypertensive disorders of pregnancy: 2-year outcomes of the HYPITAT-II trial. Am J Obstet Gynecol. doi:10.1016/j.ajog.2019.03.024.

EXPERT COMMENTARY

In women with mild hypertensive disorders in the preterm period, the maternal benefits of delivery should be weighed against the consequences of preterm birth for the neonate. In a recent study, Zwertbroek and colleagues sought to evaluate the long-term neurodevelopmental effects of this decision on the offspring.

Details of the study

The authors conducted a follow-up study of the randomized, controlled Hypertension and Preeclampsia Intervention Trial At Term II (HYPITAT-II), in which 704 women diagnosed with late preterm (34–37 weeks) hypertensive disorders in pregnancy (gestational hypertension, chronic hypertension, or mild preeclampsia) were randomly assigned to immediate delivery or expectant management.

Expectant management consisted of close monitoring until 37 weeks or until an indication for delivery occurred, whichever came first. Children born to those mothers were eligible for this study (women enrolled during 2011–2015) when they reached 2 years of age; 342 children were included in this analysis. Of note, children from the expectant management group had been delivered at a more advanced gestational age (median, 37.0 vs 36.1 weeks; P<.001) than those in the immediate-delivery group.

Survey tools. Parents completed 2 response surveys, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL), between 23 and 26 months’ corrected age. The ASQ is designed to detect developmental delay, while the CBCL assesses behavioral and emotional problems. The primary outcome was an abnormal result on either screen.

Results. Based on 330 returned questionnaires, the authors found more abnormal ASQ scores (45 of 162 [28%] vs 27 of 148 [18%] children; P = .045) in the immediate-delivery group versus the expectant management group, most pronounced in the fine motor domain. They found no difference in the CBCL scores. The authors concluded that immediate delivery for women with late preterm mild hypertensive disorders in pregnancy increases the risk of developmental delay in the children.

Study strengths and limitations

This study is unique as a planned follow-up to a randomized, controlled trial, allowing for 2-year outcomes to be assessed on children of enrolled women with mild hypertensive disorders in the late preterm period. The authors used validated surveys that are known to predict long-term neurodevelopmental outcomes.

Continue to: This work has several limitations...

This work has several limitations, however. Randomization was not truly maintained given the less than 50% response rate of original participants. Additionally, parents completed the surveys and provider confirmation of developmental concerns or diagnoses was not obtained. Further, assessments at 2 years of age may be too early to detect subtle differences, with evaluations at 5 years more predictive of long-term outcomes; the authors stated that these data already are being collected.

Finally, while these data importantly reinforce the conclusions of the parent HYPITAT-II trial, which support expectant management for mild hypertensive disorders in the late preterm period,¹ clinicians must always take care to individualize decisions in the face of worsening maternal disease.

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,¹ introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.^2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,^2-4 while others suggesting an improvement in select newborn quality outcome metrics.⁵ The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.

EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,¹ introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.^2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,^2-4 while others suggesting an improvement in select newborn quality outcome metrics.⁵ The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.

EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,¹ introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.^2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,^2-4 while others suggesting an improvement in select newborn quality outcome metrics.⁵ The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.