Preventing Prematurity: An Expert Interview With Alan R. Fleischman, MD

Katharine M. Hikel, MD

Disclosures

December 18, 2009

Editor's Note:

The March of Dimes was founded by President Franklin D. Roosevelt in 1938 as the National Foundation for Infantile Paralysis, establishing a nationwide fundraising, community support, and research program in response to the decades-long polio epidemic that had affected Roosevelt himself. Comedian Eddie Cantor dubbed the effort the "March of Dimes"-- a pun on a popular newsreel feature, "The March of Time"; the name stuck. The grassroots campaign was hugely successful; the foundation supported the development of the Salk injectable polio vaccine in 1948, and the Sabin oral vaccine in 1964. The National Foundation officially became "The March of Dimes" in 1979.[1]

With the success of the polio vaccination program, the Foundation's concern became the prevention of birth defects and the overall welfare of infants and children. The March of Dimes has supported: Dr. Virginia Apgar's standardized neonatal scoring system; the phenylketonuria test; the first successful bone marrow transplant to correct a birth defect; in utero diagnoses and treatments; federal funding for the Women, Infants, and Children (WIC) program; the discovery of the use of surfactant; and genetic research and gene-based therapies as well as national and international political activity in support of maternal and pediatric health and well-being.[2]

In 2003, the March of Dimes initiated a multimillion-dollar campaign to address the burgeoning problem of premature birth. In October 2009, the Foundation hosted a "Symposium on Quality Improvement to Prevent Prematurity" in Arlington, Virginia.

Alan R. Fleischman, MD, is Senior Vice President and Medical Director of the March of Dimes Foundation. A pediatrician, neonatologist, and bioethicist, he was Director of Neonatology at the Albert Einstein College of Medicine, where he is Clinical Professor of Pediatrics, and of Epidemiology and Population Health. He is coauthor of Pediatric Ethics -- From Principles to Practice.[3,4] Dr. Fleischman spoke with Medscape shortly after the recent symposium had taken place.

Medscape: The March of Dimes has taken on preterm birth as a chief concern. The Foundation reports that 1 in 8 babies -- more than a half million per year -- is now born prematurely and that this number has been rising over the last 20 years.[5,6] Can you talk about the "tipping point" in the prevalence and consequences of preterm birth that triggered this current course of activism?

Dr. Fleischman: The March of Dimes has had a prematurity campaign for 7 years. In the first 5 years, we focused on enhancing awareness -- to make prematurity a public health concern -- and on enhancing research into the root causes of prematurity. Of course we were interested in slowing the rate of increase and in decreasing the overall rate of prematurity. We were very successful in the first 2 aspects: (1) the level of awareness, both in the professional and in the public sector has increased dramatically; and (2) we have gotten the attention of research funders -- the National Institutes of Health (NIH) and others -- to join us in funding research into the root causes of prematurity.

During the first 5 years of the campaign, we saw a rapid rise in the prematurity rate, mostly in late preterm births (babies born between 34 and 37 weeks' gestation). The birth rate of the very smallest babies hasn't changed that much, even though mortality has improved in this group. So, we have reached a tipping point -- a moment in time where we are poised to make a real difference in the rate of preterm birth -- to "bend this curve -- and turn it around."

Medscape: We know that a certain amount of prematurity is related to the mother's medical history: cervical and uterine abnormalities, multiple gestations, and previous preterm births. How does the risk for prematurity related to these patient characteristics compare with the risk associated with lifestyle factors, such as smoking, alcohol and other drug use, and lack of social support?[7]

Dr. Fleischman: We can't put hard metrics to the distinction between those groups of risk factors. Certain factors, like race and ethnicity, are unchangeable. But some psychosocial and lifestyle factors -- smoking, alcohol, chronic stress, and drug use -- are key elements that we can influence with good social services, public health services, and local community based interventions to support women who are pregnant. We also know that home visitation and nurse-led programs work.

Prenatal care is important, but it's not enough by itself to overcome the effects of negative psychosocial and behavioral factors. So, the March of Dimes has been aggressively supportive of women's health, from young childhood all the way through the reproductive age range, because many of these lifestyle issues -- and of course today, that includes being overweight, along with smoking and alcohol use -- many of these issues really begin long before pregnancy. Prenatal care makes a difference, but it's not sufficient to change the life course of the woman so that we can actually have an effect on fetal outcome.

A good deal must be done in terms of what has been called "preconception care," or what we might call "women's healthcare," prior to when a woman even considers getting pregnant.

The other factors that you mentioned -- the biological factors, which include genetic predisposition, and factors like uterine abnormalities, multiple gestations, and previous preterm birth -- these are factors on which we're working very hard through research to really look at their root causes. Much is now known about inflammation and infection and about previous preterm birth. We now have a drug, 17-alpha-hydroxyprogesterone, that we can use in certain cases to prevent recurrence when a woman has had a previous spontaneous singleton preterm birth. We're making a difference there.

So, there is root-cause work in the sciences and social and behavioral work on other factors. There is a great deal of overlap, and that's why much of the work requires large populations. Prematurity is a complex issue.

Medscape: The March of Dimes advises professionals that every pregnant woman is at risk for premature birth.[8] How can we approach childbirth from a more preventive perspective rather than viewing birth as a potential for medical or surgical intervention?

Dr. Fleischman: The prevention message is key. It begins with public awareness and continues with the women's health issues that I raised before: we need to be proactive and talk prospectively to women about their health, as young adolescents, and as they're getting into their reproductive years. Women need to be thinking about what has been called a reproductive plan so they can prepare for their pregnancies in the best possible health. Prevention is the message, and we're quite interested in health professionals thinking that way too; we don't want to inappropriately medicalize pregnancy or inappropriately intervene in a woman who is not at risk for either herself or her fetus.

Every adult in America is at risk for heart disease; we talk about preventive measures and social interventions that can prevent that. That's the approach we need to take with prematurity. We need to change the discussion from intervention when there are problems to prevention and prioritizing health as the outcome. I think that with the current administration and with the focus on healthcare reform and public health, we can change or transform our way of thinking about people's lives, so that concern about prematurity is part of the concern about making sure that women are healthy so that every baby is born healthy.

That's going to be transformative. It's going to have to include compensation systems, aligning incentives, thinking about public health as the critical part of a health system, and population-based incentives. These are the keys. The March of Dimes supports all of these aspects, and we teach health professionals about risk factors for preterm birth and prevention of premature labor.

Women also need to understand what preterm labor feels like, as a part of their childbirth education, so that they can seek help earlier. In many cases, we do have the ability to prevent early delivery.

Medscape: Has iatrogenic prematurity increased over the last few decades? If so, would this be related to the push for "actively managed" birth since the 1980s? How does late preterm birth fit into this picture?

Dr. Fleischman: About 72% of all premature babies are now born "late preterm," defined as 34 and 0/7th to 36 and 6/7th weeks' gestation. That so many of these babies are being born early is directly correlated with actively managed pregnancy. In the prematurity literature, that's called "medically indicated" iatrogenic prematurity. We believe that a substantial proportion of these births are not medically indicated. But actually, there are some positive things about active management of pregnancy. We don't want anyone to get the idea that there aren't some benefits to early delivery when women are sick, or fetuses are in trouble. Every delivery should be at the right time for the right reasons.

But I think part of that movement to actively manage pregnancy has gone overboard. It has caused any small change -- any increase in blood pressure, any concern about diabetes, or fetal well-being -- to result in a very aggressive management strategy with inductions before they're needed. Inductions tend to result in cesarean deliveries. The other thing that has increased iatrogenic prematurity is the fact that both women and health professionals are scheduling deliveries. This clearly has convenience benefits for both parties, but I don't think we were sufficiently aware of the serious consequences of doing this. The American Congress of Obstetricians and Gynecologists (ACOG) has said that no elective induction or cesarean (C)-section should occur before 39 weeks. Yet, whenever this has been studied, it's been shown that the rule has not been applied in most settings -- if not all settings. And that creates some iatrogenic prematurity.

The other issue that the March of Dimes is concerned about, based on an Institute of Medicine (IOM) report on prematurity, is that we need to have better gestational dating. When you're making decisions [about delivery] at 37, 38, or 39 weeks, it's critically important to know how many weeks the pregnancy actually is. We've been arguing, and the IOM report, the Surgeon General's Conference on Prematurity, and others have indicated that we need early ultrasounds and better gestational dating, so that when we make these decisions, we're not off by 2 or 3 weeks.

The reason we're fairly certain that much of the late prematurity is iatrogenic is because of what happened at this symposium. We invited the Hospital Corporation of America, Ascension Health, Premier Health, Geisinger Health System, Intermountain Health, and United Health to give us their data. All of these programs have done interventions of one sort or another to decrease early -- pre 39 weeks -- inductions and consequent cesarean deliveries. And, in fact, when they do that, they dramatically decrease, first, their late preterm birth rate, second, their C-section rate, third, their neonatal intensive care admission rate, and they have better outcomes and lower costs with no increased adverse outcomes of pregnancy, and no increase in stillbirths.

What we see from those programs -- and we now have published data, which were presented at this meeting -- is that you can decrease these inappropriate iatrogenic deliveries and have better outcomes without any adverse effects. So, that proves the hypothesis that some of these [early births] are certainly unnecessary.

Medscape: On the March of Dimes Website, you spoke out strongly about the role of cesareans in the increase in late prematurity.[9] Was there any discussion of reform among the obstetrical community?

Dr. Fleischman: Absolutely. I think that the increase in cesarean rate directly correlates to the increase in induction rates. If you induce women early, when the cervix and uterus aren't ready for labor, you will have an increased cesarean rate. Once the woman is admitted and induced, and her membranes are ruptured, that's a train that isn't going to stop until the baby is born. The increase in the rate of cesarean deliveries is a big part of the increase in late preterm births.

The obstetric community, to its credit, is absolutely in favor of no inductions or C-sections before 39 weeks unless there is a clear medical indication. We had no pushback. What we did have, though, was the observation that it's a hard rule to enforce because it takes not only the commitment of the obstetrician but also the commitment of the hospital and the nursing staff and clear discussions with women, who present situations like, "Grandma's coming in from California, she's going to be here on Tuesday, maybe we could have the baby on Wednesday so she can be here for the rest of the week to help." But what if she's only at 38 weeks, and Grandma can't stay for 2 more weeks. It's all of this that we hear from our obstetric colleagues. We're helping them to learn the script to explain to patients why every week counts and to insist that women not deliver before 39 weeks.

Dr. Laura Riley, who runs the maternal-fetal medicine program at the Massachusetts General Hospital, did a simple study there that she reported on at the symposium. She said that there are 6 maternal-fetal medicine experts at Mass General -- 3 of whom had chaired the ACOG Committee on Practice. These are people who know the rules. She looked at their elective deliveries; the mean time was between 38 and 39 weeks, and she was astounded that at the Mass General Hospital, they couldn't do better. In fact, they found some babies who were admitted to the neonatal intensive care unit (NICU) and had gotten sick -- so they cracked down. They created a system so that doctors can't induce women before 39 weeks unless they get the chief of service to approve it for clear reasons. So, that's what's going on around the country -- we're beginning to see this tipping point where we can't leave it up to doctors alone. We can't leave it up to the nurse who's booking the induction or the C-section; we've got to create rules in hospitals with clear standards. That's why quality improvement -- analysis of data, the creation of rules, and holding people accountable -- is so important.

Medscape: What about the problem of multiple gestations as a cause of iatrogenic prematurity?

Dr. Fleischman: That is a preventable cause of prematurity. We're working on this with the American Society for Reproductive Medicine and ACOG. We have developed materials for consumers so that they understand the risks with multiple gestations, and even with twins, in generating preterm births. This is a very complex issue in the United States. There are good, voluntary standards, but we have not, at least as of yet, gone to a mandatory system of only implanting 1 embryo, as they have in other countries. There are complex issues about how we pay for these services as well as about the women in America who are beginning pregnancies later in life. This is a small but preventable part of the prematurity problem that we are working on. It was not a major component of our Quality Improvement Symposium; we're focusing on this issue in other venues.

Medscape: Are certain populations showing better outcomes than others? For example, how do the outcomes compare between women using midwifery/home birth/"expectant management" services vs obstetrics/hospital birth/"active management" services? And how do the outcomes compare between women residing in the United States vs those in European countries?

Dr. Fleischman: First of all, there is an increase in prematurity around the world; we reported in the March of Dimes White Paper on Preterm Birth: The Global and Regional Toll that in fact there are 13 million premature babies born every year around the world. About a million of those babies die. The United States leads the increasing rate of prematurity in developed countries. North America and Africa are the 2 regions with the highest rates of prematurity.

In comparing outcomes between women using midwifery, home birth, or expectant management vs a more active management strategy, there is no question that you can combine those strategies. Midwives working in collaboration with physicians in hospitals and in birthing centers attached to hospitals can provide excellent care for women. The midwives at our Quality Improvement Symposium were quite articulate in talking about expectant management and midwifery approaches, and many of those were intimate colleagues of practicing obstetricians and worked very well with them. I began this work in the 1970s, and it has always been hard to compare midwifery service deliveries with obstetric non-midwifery service deliveries because clearly, different women seek those services, so it's never random. But there is no question that the midwifery programs end up with deliveries not being induced unless there are clear indications. Midwifery services don't just wait until 39 weeks; they wait until the initiation of labor, which God in Her wisdom used to think was a good idea, and I think that it's probably a good idea for most women, yet only about half of the women in America are being allowed to go into natural labor. So yes, there is a lot of benefit to thinking about the expectant management, "high-touch," caring approach, which we think is quite appropriate.

Medscape: We now have the NICU capacity to "save" extremely preterm infants born as early as 23 weeks and weighing as little as 500 g (just over 1 lb).[10,11] Have rates of very early prematurity changed over time -- is a certain amount of pregnancy loss inevitable in our species? What is the evidence on the survival of such early birth babies, and what are the outcomes in terms of significant long-term impairments?

Dr. Fleischman: Rates of very early prematurity have not changed much over time; they continue to be a small proportion of total prematurity. But our care of those babies has improved; and their survival, at 23 weeks and above, has dramatically increased. Yet, the babies who are born at 23, 24, and even 25 weeks have a very high proportion of morbidity, or long-term consequences, of preterm birth.

Certainly, all species are susceptible to preterm birth. The human species has elected, I think appropriately, to attempt to intervene to save those babies. When I began to practice neonatology, the threshold of viability was at about 1000 g -- that's 2 lb and a few ounces. Those babies now survive at about 94%, and their outcomes are quite good.

So, it is important to try to help those babies. But recent data suggest that we really have reached a moment in time -- maybe not forever, but certainly based on our present capabilities in clinical care -- where 23- and 24-week babies are surviving, but their survival has not changed over the last decade, and their morbidity remains quite substantial.

In terms of impairments, we're seeing chronic lung disease, neurodevelopmental problems like cerebral palsy, cognitive deficits, and problems with hearing and vision. It's the littlest babies who are having substantial problems -- but it's not every one, and that's part of the prognostic uncertainty in taking care of very small neonates. We're not seeing improvement in intact survival, and we're still seeing major morbidities, facts that families and doctors need to remember when making the hard decisions in these threshold-of-viability babies.

Medscape: Among the risk factors for prematurity is lack of prenatal care, which is presumably related to poverty and inadequate access to healthcare and education. How does the March of Dimes address these ongoing issues?

Dr. Fleischman: First, the March of Dimes is very proud to be part of the coalition that assisted in passing the children's health insurance program -- the second bill that President Barack Obama signed after he was elected. That bill had passed a few other times with our support, and that was the first time it wasn't vetoed. That bill is critical because it allows states to insure pregnant women and begins to open up discussions on healthcare reform in areas that we've been very involved in, like preconception healthcare, women's healthcare, and not allowing pregnancy to be a preexisting condition for insurance; so we're working to make sure that's all part of healthcare reform.

At the same time, we're also helping businesses to create healthy environments for pregnant women and for women who are considering pregnancy as well as for women who have had babies. We're working with some of the top businesses, and many insurers, to make sure that the business environment is appropriate. We're doing this both at the federal level and in every state in the country, where we're working to assure that women have access to health insurance, and once they have that, to have access to high-quality services.

Medscape: The recent March of Dimes Symposium on Prematurity was a remarkably collaborative effort involving senior-level physicians, midwives, nurses, public health professionals, employers/business people, insurers, and government representatives -- a model of interdisciplinary collaboration. Can you tell us about drawing such a diverse group together for this 1 issue?

Dr. Fleischman: Everyone was on the same page. The March of Dimes prides itself on being able to convene all of the stakeholders to make open and collaborative discussions possible. We have an ongoing partnership with ACOG, The American Academy of Pediatrics, The American College of Nurse-Midwives, and the Association of Women's Health, Obstetric and Neonatal Nurses. We discuss issues related to women's health and prematurity prevention; and this was a natural outgrowth of those collaborations. It doesn't surprise me at all that we were able to bring all of these people together. I think we have a closer alliance than ever before among these groups. We've now invited the American College of Family Physicians to join us; they do a good deal of the prenatal care in America, and certainly a lot of the women's healthcare delivery. It's a trademark of the March of Dimes to bring the stakeholders together to make a difference.

Medscape: How did the health insurance community present its position on this concern? Is there a move toward coverage of prevention? Was there any discussion of the prevalence of obstetric interventions in this discussion?

Dr. Fleischman: The health insurers were represented at the symposium as were healthcare delivery systems and public payers. We found that all of them are interested in this issue, are concerned about costs and outcomes, and are intrigued by the ability to decrease costs while achieving better outcomes.

When we looked at the cost of privately insured, employer-paid-for deliveries, we found that preterm deliveries cost close to $50,000 per maternal and baby care; but that full-term, healthy babies cost less than $5,000 -- less expensive by a factor of 10. Clearly a lot of dollars are being spent. These sick babies do generate a lot of income for hospitals, and the symposium pointed out that the incentives aren't all aligned. A hospital that sees its NICU admissions decreasing is going to lose money.

We need to take this into account when we think about how to incentivize healthy outcomes rather than NICU admissions. This was a discussion at the meeting, as the underpinning of healthcare reform was discussed. The law that is being debated right now does not include that basic transformation of what we pay for in healthcare. However, there is a lot of positive discussion now about aligning incentives so that we can pay for health rather than for illness. That was part of the discussion by the health insurance community ready to consider how to incentivize new ways of thinking.

Medscape: How do you envision the evolution of a multidisciplinary, collaborative approach to this problem? Do you have a time frame for predicting when we should see a significant drop in rates of prematurity?

Dr. Fleischman: This conference will result in several publications and, I think, a change in the obstetric community so that it is more aggressively seeking to put quality improvement programs in every hospital in America. It will result in the insurance community thinking creatively about how to incentivize these activities, and it will increase the likelihood of success of programs that both insure and deliver healthcare. I believe that we will see a difference in the late preterm rates within the next 2 years.

Gestation is 9 months, or 40 weeks, and we are beginning to see awareness of that in certain hospitals and programs, and we are beginning to see it across the country. The tipping point moves quite rapidly to the realization that late preterm birth is serious, these babies can get sick, and that we can prevent the unindicated early deliveries to make a real difference.

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