Currently, midwives attend only about nine percent of the nearly 4 million U.S. births annually. While this is likely an underestimate since the legality of midwife-attended births varies across states and some women may not report their midwives’ presence, it is clear the share of midwife-attended births in the United States is much lower than in many developed nations. In the U.K., for example, midwives deliver approximately half of all babies and rates can be even higher than this in some Nordic countries.

My research as a health economist, and my experience as a mother, convinces me that we should increase the participation of midwives in the birthing process. I believe midwives were partly to thank for my own positive birth outcomes because of their strong emphasis on ‘normalcy’ during my prenatal care and births. I’d like to share my stories as an example.

My Birthing Experiences with Midwives

My partner and I chose to deliver our three babies under the care of certified nurse midwives (CNMs). The first birth was nerve-racking and difficult labor, apparently because of the baby’s occiput (or sunnyside-up) and asynclitic (neck-kinked) position. My memories are freeze-frame moments, such as when our midwife told us the baby’s heartbeat was decelerating during contractions, or when my labor stalled and they called in a physician. And, of course, when the baby was born (with the help of IV fluids and oxygen), 19 hours after my water broke, and 15 hours after the contractions had started.

With the second, there was a lot of waiting followed by a quick birth with some complications. My water broke one evening, but contractions didn’t begin until late-next morning and our second son was born less than an hour later. I remember the midwife entering the room, listening to one contraction, and telling me the baby was coming. The baby was born grey and limp, the umbilical cord wrapped tightly around his neck. His one-minute Apgar score was a five—which is not good—and the five-minute score was a nine—much better.

Labor for baby three began in the middle of the night and our third son was born around noon, a more textbook birth. However, with this one, my water never broke. The baby was born “en caul,” from the Latin for “in the veil”, meaning the amniotic sac remained intact during his entire birth. This is apparently very rare, and as such, has been associated with many superstitions and folklore about a baby’s temperament and gifts.

A Growing Recognition of Midwifery in the U.S.

Within-country studies from non-US based populations unequivocally show that women who had midwife-led continuity of care models were less likely to experience epidurals, instrument-assistant birth (such as forceps, or vacuum-assisted delivery), preterm birth less than 37 weeks, as well as less fetal loss and neonatal death. A small but growing U.S. body of research also shows positive health outcomes associated with midwife-attended births.

A recent study by Laura Attanasio, PhD, and Katy Kozhimannil, PhD, MPA, found that women delivering in hospitals with more midwife-attended births had lower odds of Cesarean section and of receiving an episiotomy, although no reduced odds of labor induction or severe maternal morbidity. Another recent study by Molly Altman, PhD, MPH, CNM, and colleagues found that medically low-risk women delivering with CNM-led care in hospitals had lower use of labor and birth interventions, including Cesarean and vacuum-assisted delivery, epidural anesthesia, labor induction, and cervical ripening compared to similar low-risk patients with OB-GYN-led care. Midwife-led mothers also had shorter maternal duration of stay and lower overall costs compared to similar women having OB/GYN-led care. Moms and babies’ outcomes were comparable across groups.

Here at Mount Sinai, too, midwives work alongside obstetricians and are seen as an integral part of the care offered to women. In 2020, for example, nine midwives delivered more than 450 babies at The Mount Sinai Hospital, and another nine worked delivering babies at Mount Sinai West.

Challenging the ‘Culture of Normalcy’

Birth stories are amazing. Ask a mother about her birthing experience and you will not be disappointed. Each birth is dramatic and encompasses many emotions—excitement, fear, happiness, pain, love, comedy, suspense, beauty, and sometimes unfortunately, sadness. Listening to many stories, it becomes clear that the similarity of births actually lies in their differences: insofar as each story is guaranteed to differ in its details, to have something unexpected occur, every birth could be considered normal.

In a joint commentary for Obstetrics & Gynecology, Chitra Akileswaran, MD, MBA, and midwife Margaret Hutchison, CNM, MSN, discuss that the ‘culture of normalcy’ is currently missing from the ethos of the U.S. health care system. Modern obstetrics was developed to avoid the worst possible outcomes–that is, death of moms or babies–and has indeed successfully reduced the morbidity and mortality of childbirth. However, Dr. Akileswaran and Ms. Hutchison argue that perhaps the pendulum has swung too far. Our fear of avoiding bad outcomes may now be preventing us from supporting the normal processes of childbirth, resulting in undue intervention and potentially causing harm.

So how can we meet the needs of most healthy, low-risk pregnant women outside the medical model of childbirth, albeit still gratefully accessing medical tools when necessary? Increasing the participation and contributions of midwives in the United States could re-establish this ‘culture of normalcy.’ Midwife participation could be manifested by improving reimbursement for midwives, passing state licensure laws to increase both the scope of care midwives can provide and their autonomy from physicians, increasing physician exposure during training to midwife-led care models, growing the midwife workforce, and increasing the presence of midwives in hospitals.

Regardless of how we get there, it is important to remember, as Dr. Akileswaran and Ms. Hutchison write, that “striking the balance between averting poor outcomes and normalcy compels us to make room at the table for both obstetricians and midwives.”

Ellerie Weber, PhD, MBA, is a member of the Blavatnik Family Women’s Health Research Institute and her research focuses on economic issues of cost, pricing and competition in the health industry. She is an Assistant Professor at the Icahn School of Medicine at Mount Sinai, and affiliated with the University of Texas Health Science Center at Houston School of Public Health.

Evidence suggests pregnant women are at increased risk of developing severe COVID-19 if infected from SARS-CoV-2, which in turn increases risk of preterm birth, pregnancy loss, severe illness and death, underscoring the critical importance of vaccination.  As of March 1, 15 states, including New York, and Washington, D.C. expanded coronavirus vaccine eligibility to pregnant women as a ‘high risk’ condition. Yet, women are confronted with vague and at times contradictory messages regarding the safety of coronavirus vaccination during pregnancy.

Mixed messaging between leading advisory groups such as the World Health Organization and the Centers for Disease Control and Prevention is a direct result of the lack of evidence among pregnant women due to their exclusion from pre-market clinical trials. This neglect is not without precedent or public health cost. In light of women’s history month, the historical lessons on pregnant woman’s involvement in vaccine research warrants reflection in the context of the COVID-19 pandemic and going forward.

The eligibility, and even prioritization, of pregnant women to receive the coronavirus vaccine is at stark odds with their exclusion from coronavirus vaccine pre-market clinical trials. The main reason for this exclusion is concerns over liability of potential fetal harm. Rather than affording protection, however, avoiding knowledge generation among an at-risk population forces women to make health decisions using insufficient evidence. Both Pfizer-BioNTech and Moderna coronavirus vaccines use a mRNA platform which is immunogenic, but non-infectious, meaning there is no risk of infection from the vaccine.  While evidence is limited, there are also no documented risks to the fetus nor has there been demonstrated risk in animal studies.

The eligibility of pregnant women in vaccine rollout raises questions regarding the timeliness of animal and toxicity studies. Why, for example, were such tests not carried out earlier, such as when a candidate vaccine was identified? Further, when it became clear that vaccines’ benefits outweighed potential harm, why was an amendment to include pregnant women not created?

Instead, conducting a clinical trial to assess safety and efficacy among pregnant women post initial eligibility will have the very real challenge of identifying participants that agree to be potentially assigned to a control arm, and risk forgoing a possibly life-saving intervention. Without a control arm, it could take years for a sufficient amount of data documenting adverse side effects to emerge for valid comparison.

The public health cost of delay in timely and appropriate inclusion of pregnant women in clinical research has alarming historic lessons.

During the 2018 Ebola epidemic in the Democratic Republic of Congo, for example, vaccination policies at first excluded pregnant and lactating women. Although the policy was reversed 10 months later, the delay led to a case fatality rate of more than 90 percent among pregnant women in some outbreak areas.

Other historic examples of delayed public health benefit include administration of yellow fever and rubella vaccines. These examples not only delayed epidemic control at the cost of the health of women and their infants, but also resulted in elective termination of pregnancies which were otherwise intended.

The persistent caution due to theoretical risks in conducting pregnancy-related research perhaps most notably stems from two events during the 1950-1960s. The first followed the prioritization of pregnant women and children in the 1955 campaign to administer the new inactivated poliovirus vaccine. One company (Cutter Laboratories) ineffectively inactivated the virus such that up to 200,000 recipients mistakenly received an unattenuated strain of polio, resulting in 200 cases of varying paralysis and 10 deaths. Soon after, the use of thalidomide, a drug widely prescribed in Europe for nausea during pregnancy in the early 1960s, was recognized as a teratogen following widespread birth defects after its use.

The long-lasting influence of these tragedies has precluded the participation of pregnant women in clinical trials of non-obstetric related therapeutics to this day. Indeed, a global review of clinical trial registries identified less than 2 percent of all COVID-19 registered trials, including the use of a medication/supplement, included pregnant women.

Balanced against the theoretical risk of fetal harm, however, is the cost of excessive caution. Excluding pregnant women from pre-market trials not only causes some women to forgo access to a potentially lifesaving intervention, but vaccine policy based on limited or poor-quality data also has inherent health risks.

Vague guidance which advises women to discuss vaccination during pregnancy in consultation with their clinician may reinforce disparities among poor women who are more likely to be uninsured or have inadequate access to care. The resulting uncertainty undermines confidence in essential public health services needed to achieve epidemic control.

Rather than a misguided attempt of protection through exclusion, the needs of pregnant women must be represented in research. Instead of pregnancy constituting a sufficient reason for exclusion, the complex biological and ethical tradeoffs between maternal and fetal risks and benefits must be weighed using information on potential for harm extrapolated from animal studies, whether the risks of inclusion can be minimized, and the importance of the evidence to be gained for maternal and fetal health.

Ultimately, we must not underestimate the capacity of women to make informed decisions about whether or not it is appropriate to participate in research trials which have implications for their benefit. Otherwise, we risk repeating missteps of the past which ultimately block women from receiving the same evidence-based care available to men.

Katharine McCarthy, PhD, MPH, is a perinatal epidemiologist and a postdoctoral research fellow with The Blavatnik Family Women’s Health Institute at the Icahn School of Medicine at Mount Sinai. Her research focuses on disparities in maternal and newborn health, the measurement of essential maternal and newborn interventions and promoting reproductive autonomy, particularly among adolescents.

Pregnancy is not only a time filled with wonder and joy, but also a time for women to optimize their health. It is important to focus on general healthy behaviors such as avoiding tobacco and excessive alcohol use, but during the flu season, generally fall and winter, it is also an excellent time to discuss immunizations in pregnancy. According to the American College of Obstetricians and Gynecologists (ACOG), immunizations are an essential part of prenatal care. Immunizations are known to reduce the risk and burden of infectious disease, not only to the mother, but also to the newborn child.

Both ACOG, and the CDC’s Advisory Committee on Immunization Practices (ACIP) recommend immunization against seasonal influenza to any woman who is pregnant during the flu season. Because hormonal changes in pregnancy can make pregnant women more prone to infections, influenza can be especially risky during pregnancy. Influenza infection during pregnancy can be more severe, and increases the risk of preterm and cesarean delivery.

For example, during the 2009 H1N1 pandemic, pregnant women accounted for five percent of all deaths, but made up only one percent of all influenza infections. Moreover, influenza infection in the first trimester increases the risk of congenital anomalies. Immunization reduces the risk of influenza illness, hospitalizations, and also protects the infant for several months after birth.

Tetanus, diphtheria, and acellular pertussis (Tdap) is another vaccination recommended by both ACOG and the ACIP. Vaccinating the mother transfers antibodies to the fetus that protect it during the newborn period against the respiratory illness pertussis, also called whooping cough. This infection can be particularly severe for newborns, as they are vulnerable to this infection but are not vaccinated against whooping cough until two months of age.

In fact, most children who are hospitalized for pertussis are those that are less than two months old— vaccination can reduce this risk by almost 50 percent.  Tdap is therefore recommended with every pregnancy (even if you have had the vaccination previously) around 28 weeks. This ensures that antibodies to pertussis are transferred from the mother to her fetus with each pregnancy, protecting the newborn from serious pertussis in the first months of life.

Most immunizations are safe to administer during pregnancy. Immunizations are either derived from inactivated viruses, or from live, but weakened virus. Some examples of vaccines derived from inactivated viruses include influenza and Tdap. Immunizations made from a weakened (also called a live-attenuated virus) are contraindicated in pregnancy. Some examples of live-attenuated vaccines include the measles, mumps and rubella (MMR) and varicella vaccines; these should not be given during pregnancy. Some vaccinations, such as the pneumococcal, or hepatitis B vaccine, are recommended for certain pregnant women (i.e. women with diabetes mellitus). Most vaccines can be administered to post-partum and breastfeeding women.

The recent COVID-19 pandemic has highlighted the role that public health interventions, including immunizations, play in protecting the health of populations. Pregnant women should adhere to strategies recommended by the CDC that mitigate community spread of COVID-19 including hand washing, wearing masks, and social distancing. The U.S Food and Drug Administration has granted emergency use authorization to three COVID-19 vaccines and more will likely seek approval. Though pregnant women were excluded from the clinical trials of these vaccines, the CDC notes that limited data from animal studies have not demonstrated safety concerns.

According to ACOG and the Society for Maternal Fetal Medicine (SMFM), symptomatic pregnant women with COVID-19 are at increased risk of severe illness and death compared to non-pregnant peers. Therefore given these risks, both ACOG and SMFM stress that COVID-19 vaccines should not be withheld from pregnant women, and that pregnant individuals should be free to make their own informed decisions regarding COVID-19 vaccination after discussion with their provider. Information about COVID-19 is rapidly evolving, and women are encouraged to seek further information from the sources listed below as it comes out.

Being up to date with recommended immunizations is an excellent way of optimizing pregnancy care. Most immunizations are safe in pregnancy, and both the CDC and ACOG recommend vaccination with influenza and Tdap with each pregnancy.

Juan A. Peña, MD, MPH, is a Maternal Fetal Medicine fellow at the Icahn School of Medicine at Mount Sinai and a member of the Blavatnik Family Women’s Health Research Institute. His research and background are in Obstetrics and Gynecology and Preventive Medicine.