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Medscape: Dr Lawrence, can you tell us what is considered early-term birth and how often are elective deliveries occurring at this gestational stage?

Hal C. Lawrence III, MD, FACOG: Well, those are 2 very good questions. First off, I think we need to realize that early-term birth is an evolving, very new term. I know that the National Institute of Child Health & Human Development (NICHD) is getting ready to have a review conference on this to truly "define" early term. Late-preterm birth, between 34 through 36 weeks, is now well defined. We are looking at week 37 ⁰/₇-weeks' gestation through week 38 ⁶/₇-weeks' gestation as being early term, with full term at 39 weeks (Table 1).^[1] Historically, "term" was defined at 37 weeks. More understanding and research has prompted us to realize the importance in fetal development occurring between 37 and 39 weeks -- the 37- and 38-week-old infant -- is not the same as the 39-weeker.

Table 1. Proposed Definitions

From: Clark SL, et al.^[1]

Now, the second part of this question is a little harder to parse right now. We need better data. We really need to have good registries to track the incidence of elective or nonmedically indicated delivery, because between 37 ⁰/₇ and 38 ⁶/₇ weeks, around one-fourth of all babies are born; more than 80% of those births occur because either they are indicated deliveries or spontaneous deliveries.^[2,3] That is a million births between 37 ⁰/₇ and 38 ⁶/₇ weeks in the US.^[2] What part of that is nonmedically indicated deliveries is a little harder to parse. In an article in the American Journal of Obstetrics & Gynecology, Dr Steven L. Clark talked about nonmedical identical inductions for delivery being at about 5%, and if you look at the denominator of "all deliveries" -- if the denominator is deliveries between 37 and 39 weeks -- it may be 20% of that particular group.^[4] A reasonable number is several hundred thousand nonmedically indicated deliveries between 37 and 39 weeks.

I just want to clarify that a lot of women will spontaneously go into labor, a natural labor, and deliver before 39 weeks. But we also have to recognize that these women will labor and deliver and have very healthy, normal babies. We do not want to make women feel that they have done something wrong if they go into to labor and deliver spontaneously at 38 weeks.

Medscape: Do we know how many of those deliveries are induced vs elective cesarean at this point?

Dr Lawrence: That has not been parsed. We need to get better data on nonmedically indicated inductions and nonmedically indicated, scheduled cesarean sections. Scheduled, repeat cesarean sections will still occur, but our recommendation is that unless a problem arises, they still should not occur until 39 weeks' gestation.

Medscape: Dr Dolan, can you discuss what new data exist on the maternal risks and complications involved?

Siobhan Dolan, MD, MPH: Well, with regard to early-term birth, the real issue here is balancing the risks to the mother and the fetus of staying pregnant vs the risks to the mother and the fetus of having the delivery in the early-term period. This is a very challenging and tricky balancing act.

Medscape: Dr Campbell, can you address the risks and complications for the infant?

Deborah Campbell, MD: Just as with the late-preterm infant, the early-term infant is also at risk for difficulties with early initial neonatal transitions. Early-term infants, born between 37 and 38 weeks' gestation, account for 26.88% of live births^[2] and are more likely to experience respiratory distress caused by transient tachypnea of the newborn (due to retained fetal lung fluid), or persistent pulmonary hypertension of the newborn, and prolonged newborn nursery hospitalization compared with infants born after 39 weeks' gestation.^[5,6] The risk of respiratory distress is nearly 2 to 4 times greater for infants born at early-term gestation compared with babies born after 39 weeks' gestation.^[6] The overall relative risk for neonatal illness and need for specialized neonatal care is doubled for babies delivered electively at 37 or 38 weeks of gestation.^[6] An additional perinatal factor that increases the risk of mortality and morbidity is that two-thirds of mothers who are delivered during the early-term period experience gestational complications.^[5] Among infants born after 39 weeks of gestation, less than 15% have a pregnancy complication. The rate of prolonged hospitalization for early-term infants varies 8.8% to 17.8%, 1.5- to 3-fold higher than for infants born late term (greater than 39 weeks' gestation).^[5]

Mortality rates among babies born between 37 and 38 weeks of gestation are twice as high as infants born at 39 or 40 weeks' gestation.^[7] Early-term infants are also more likely to experience feeding difficulties than infants born at 39 or 40 weeks. This is particularly important in view of the recognition of the importance of early and exclusive breastfeeding for all infants. Just as with late-preterm babies, early-term infants require enhanced support to assure effective breastfeeding initiation and continuation. Although people often consider these infants physiologically mature, they in fact behave in an immature manner. They very much parallel risks to the late-preterm infant. Population-based data from the United Kingdom have shown that early-term infants continue to be at greater risk for rehospitalization and chronic illness during infancy and in early childhood. Among their health problems are higher rates of wheezing/asthma and medication use.^[8] In addition, early-term infants have a greater rate of poor academic achievement compared with infants born after 39 weeks of gestation.^[9]

Dr Lawrence: I think it is important that people understand how this is a continuum. Historically we believed that when the fetus reached 37 weeks we would have a fetus with positive or pulmonary maturity, but in reality we have learned that is often not true. The same problems occur in late-preterm babies: the 34- to 36-week group gets better but does not really resolve statistically until we get to that 39 ⁰/₇-week gestation range. Even when you have positive pulmonary maturity, you do not necessarily have fetal maturity. I think from both the pediatric and the obstetrical sides this have been the real learning process.

Dr Campbell: I agree with you 100%, particularly as we focus on brain development. The infant's brain maturation ultimately affects not only school performance and academic achievement but control of the baby's physiologic processes. Within that last 5 weeks, between 35 and 40 weeks of gestation, tremendous brain growth is going on, increasing the brain's complexity, the connectivity of the different neural systems, and myelination. All of these are very important to the infant's ability to transition, as well as in terms of affecting ongoing growth and development. We also know that for these infants, even in terms of ongoing health issues, there are greater risks for ongoing difficulties with asthma and other respiratory diseases.^[8]

Medscape: When, then, is it medically indicated to move beyond expectant management in active-phase labor, one that is less than 39 weeks?

Dr Dolan: I think 1 important point of clarification here is the difference between "indicated" and "elective." Indicated suggests that there is a medical reason to deliver early, before 39 weeks. Elective suggests that there is no medical reason to deliver before 39 weeks. If no medical indication exists but you just simply desire to be delivered early, then we really want to emphasize the risks to the fetus of coming early, as has been pointed out. We want people to understand that in most instances, the baby is going to do better in utero until 39 weeks. However, in situations where there is a medical complication and there is a reason for delivery before 39 weeks, we expect that the baby will do better once delivered. So waiting until 39 weeks, unless there is a medical reason for delivery or labor starts spontaneously, is the best recommendation for both mom and baby to be healthy. And that's really ultimately everyone's goal.

So what are those medical indications for early delivery? In February 2011, NICHD and the Society for Maternal-Fetal Medicine put together a conference and a workshop to assess some of the medical indications and when was an appropriate time to consider delivering these women. This took into consideration maternal as well as fetal consideration.^[10]

For example, with some issues, like placenta previa, where there could be a serious and heavy maternal bleed that could be life-threatening, the summary recommendation from the experts was that at 36 to 37 weeks, it was reasonable to consider delivery if that was complicating a pregnancy. That was the point at which the balance between mother's well-being and the newborn's well-being would be best accommodated. Another is multiple gestation, where you have twins or triplets or a higher-order gestation, where fetal well-being is not continuing in utero – let's say 1 of the twins is not growing appropriately. Early delivery might be recommended at 38 weeks. Another really common complication of pregnancy is hypertension, and an associated condition, preeclampsia. Unfortunately, that condition can become quite serious. It can lead to seizures for moms. Therefore it can be an indication for delivery even if it is before 39 weeks. Other conditions include maternal diabetes, where we have to consider the mother's well-being as well as the fetus's, and again, in the early-term period -- 37 ⁰/₇-weeks' gestation to 38 ⁶/₇-weeks' gestation -- it often takes clinical judgment to balance those risks and benefits. Preterm premature rupture of the membranes (PROM) would also be an indication for early delivery -- if the membranes rupture early and it is determined that it is time to deliver the fetus.^[10]

With intrauterine fetal growth restriction (IUGR), you again might want to evaluate how the baby is doing in utero, and if the growth is not progressing you have a situation where delivery is indicated.

Dr Lawrence: I always try to tell patients that there are 2 reasons that you deliver pregnancies early: 1 is for mother and 1 can be for baby.

Another situation calling for early delivery might be HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome, which fortunately we don't see all that often. There are also situations involving the fetus. You mentioned IUGR, or a fetus might have some known congenital malformation that may need to be dealt with a little earlier than you would like to affect delivery, or there could be situations of isoimmunization.

There are fetal indications that say these babies are going to be better born early. We have to guard against sending the message that we can make all premature birth go away. There will always be reasons that mothers need to be delivered early, and there will always be reasons that some babies need to be delivered early.

Medscape: There has been some concern that reducing these elective or nonmedically indicated early-term births has led to an increase in stillbirths. Could you comment on this?

Dr Campbell: In terms of a concern about increased risk for stillbirth, I think the data do not support that. It will be important in over the next several years to try to look very closely to see if in fact we are seeing any increases in late stillbirth, but I do not think the data are there at the moment.

Medscape: What are some strategies for clinicians to educate patients about the benefits of waiting until labor occurs on its own?

Dr Dolan: I believe every woman wants to do the right thing for herself and her baby. The important part is to educate women that 38 weeks is great but 39 weeks is better. So it is worth hanging in there to give the baby time for the brain to continue to grow and to emphasize to women that at 39 weeks, the baby is going to do better in terms of feeding, growing, and school-age performance -- that so many outcomes will be better for the baby. I think once women and families hear that message, they will be convinced. The American Congress of Obstetricians and Gynecologists (ACOG) and the March of Dimes (MOD) have been working hard to get the message out to women -- to say that healthy babies are worth the wait and extra effort to reach the 39th week. I think most women are completely on board with that.

Brenda Jones, DHSc, MSN, APN-BC: As an administrator in a hospital, I can tell you that we have done things like put up educational material and get that material over to the clinic, because consistency in the message is important.

It is also important that women know this early on and not at the end of the pregnancy, when they are tired. If they have had ongoing education from the beginning of the pregnancy, it seems to be much more helpful to the patient.

Medscape: What are some strategies for clinicians to educate their colleagues about the benefits of waiting?

Dr Lawrence: At ACOG we have been doing this for a long time -- all the way back in 1979 -- telling folks that they should not be doing nonmedically indicated deliveries before 39 weeks, but we have taken it several steps further.

We now have scheduling checklists developed by our Patient Safety & Quality Improvement Committee that have been sent out to all our members. They show that you have to fulfill these criteria before you would initiate an induction or a cesarean section, and it is recommended that there be a real hard stop by hospitals if people do not meet the criteria for a delivery before 39 weeks. If there is not an indication for that delivery, the scheduling forms help identify that and suggest that those people should not be delivered because they do not meet the criteria.

We have also developed patient education pamphlets so that women are aware of the benefits of waiting. I think putting the message out there is crucial. Institutions such as Hospital Corporation of American (HCA) hospitals and Magee-Womens in Pittsburgh have instituted hard stops for nonmedically indicated deliveries early on and dramatically decreased the incidence of the procedures.

We also want to make sure that all obstetric providers -- including family doctors who are doing obstetrics and certified nurse-midwives who might be doing an induction of labor after 39 weeks -- are doing it with a patient who has a favorable cervix, because 1 of the other things we know is that if you induce labor and the cervix is not favorable, your cesarean section rate goes up. Institutions that have had these hard stops and have not induced people without medical indications before 39 weeks have actually seen a drop-off in their C-section rates.

Dr Jones: From a patient safety perspective, hospitals have a lot of educational material and are making it available to both clinicians and women to maintain the consistency of the message. In addition, the Joint Commission has established perinatal core measures that hospitals can use, and MOD has a toolkit for such hospitals, available at this link:

Less Than 39 Weeks Toolkit

What is most important is that in the hospitals you have a physician champion. Nurses cannot be the ones to say, "This is a hard stop." You have to have administration support. Hospitals are seeking administrator and physician champions so these initiatives could be carried out across the board. A few things are necessary: 1) it is important that everyone speaks the same language; 2) that there is a process to verify that the patient is indeed at 39 weeks when she calls in, and 3) that you have the physician leadership.

The other thing that hospitals are looking at is data. We are examining those cesarean sections that happened at 39 weeks and under and asking, "Why did this happen?"

Dr Dolan: I think what is most interesting is that at sites like, for instance, the Ohio Collaborative, once quality improvement and quality assurance measures were put in place, where scheduled deliveries needed to be reviewed, you saw an immediate decrease in the number of deliveries that were preterm, and then you saw improvement in perinatal outcomes.^[11]

The data are really clear at some of these leading-edge sites that put these quality improvement measures in place. Now I think the idea is to spread the word and let other hospitals and other health systems take advantage of these measures and see the great outcomes.

Dr Campbell: I think it's also important to include pediatric and family providers, and to make sure those 2 groups of health professionals are also brought into this in terms of education and outreach. Whether this is a first prenatal pediatric visit or a subsequent pregnancy, a pediatric clinician can reinforce the importance of remaining pregnant until 39 weeks of gestation and not delivering earlier than this unless there is a specific medical indication. Family providers also have an important role as providers of well-woman, prenatal, and family care. They have numerous opportunities to provide education and guidance.

Medscape: Let's talk a little about the Strong Start Initiative from the Centers for Medicare & Medicaid Services (CMS), which is a public-private initiative to reduce early nonmedically indicated deliveries. ACOG, MOD, and WebMD/Medscape are all partners in this project. How can clinicians get involved if they wish?

Dr. Jones: In February 2012, the US Department of Health and Human Services (HHS) introduced the "Strong Start for Mothers and Newborns" initiative to reduce early elective deliveries and improve outcomes for newborns and pregnant women. Strong Start builds on the work of ACOG, MOD, and others, and brings together the federal government and state and local government agencies, as well as the private sector.

Numerous studies show that early elective deliveries are associated with increased maternal and neonatal complications for both mothers and newborns compared with deliveries occurring beyond 39 weeks and women who go into labor on their own. Reducing the rate of early elective deliveries prior to 39 weeks ensures that more mothers receive safe, evidence-based care and improves the prospects for good physical and developmental health for infants. It also reduces costs by safely reducing preventable C-section rates, neonatal intensive care admissions, and other associated complications.

Strong Start for Mothers and Newborns is an initiative to reduce early elective deliveries prior to 39 weeks and to offer enhanced prenatal care to decrease preterm births for women enrolled in Medicaid and the Children's Health Insurance Program (CHIP).

More information on the Strong Start initiative can be found on the CMS website at http://innovation.cms.gov/initiatives/Strong-Start/index.html.

Dr Lawrence: I was pleased to be able to testify with Dr Scott Berns, senior vice president of chapter programs at MOD, and US Department of Health and Human Services Secretary Kathleen Sebelius, on the rollout of Strong Start.^[12] To me, an exciting thing about this program is that it is a collaboration between the federal government with CMS, medicine with ACOG, and the public with MOD, identifying the need to eliminate nonmedically indicated deliveries before 39 weeks.

We have cobranded educational materials from CMS, ACOG, and MOD that we are sending out to the public, providers, and hospitals. I think it obviously is a step in the right direction, and the fact that we were able to all work together was very significant: a triumphant approach.

Dr Jones: A lot of community partnerships exist. For instance, in the state of Illinois we actually have a program where we meet with the perinatal centers and are helping to develop some of that education that goes to the hospitals. Every hospital in the state will get that information, and nurse-midwives are invited. Various outreach programs are available for those interested in participating.

Dr Campbell: Although this has not been an issue of primary focus for the American Academy of Pediatrics (AAP), I believe the Academy will be a willing partner in efforts to raise awareness among pediatricians, the pediatric community, and families about the increased vulnerability of infants born early term.