Lauren Fleming was born 3½ months early and weighed just a smidge over 2 lbs. When her mother, Nikki Fleming, got pregnant again, her doctor administered weekly progesterone injections. Fleming’s next two children, Erin and Corbin, arrived a week shy of their due date. Giving birth to a preemie is the biggest risk factor for a repeat performance. But now, many mothers of babies born too soon may be eligible for the same pregnancy-prolonging drug Nikki Fleming received.
Approved Friday by the U.S. Food and Drug Administration, Makena — hydroxyprogesterone caproate injection, or 17P — is a synthetic version of progesterone, a hormone produced naturally during pregnancy. Pregnant women who qualify will be injected weekly in the hip — starting as early as 16 weeks and no later than 21 weeks gestation — through 37 weeks of pregnancy. (More on Time.com: Doctor’s Orders: Sex During Pregnancy Gets the Green Light)
Progesterone is integral to the initiation of labor; as labor begins, it declines sharply. So progesterone injections, in theory, should be able to ward off early labor. (In fact, research from Tufts University presented Monday at the annual meeting of the Society for Maternal-Fetal Medicine attributes progesterone’s track record in preventing preterm labor to three proteins that help strengthen fetal membranes.)
An FDA-reviewed study of 463 women with a history of premature birth found that 37% of women injected with Makena delivered early in comparison to 55% of women who hadn’t received the shot. Another study discerned no difference in the children’s development, regardless of whether their mothers had taken the drug. More research to confirm that finding is underway.
Though some babies whose mothers take Makena may not make it to full-term — as close as possible to 40 weeks — they still may gain additional time in utero. “They might not make it to 38 weeks, but they might make it from 26 to 30,” says Alan Fleischman, medical director for the March of Dimes. “Every week counts in preterm birth.”
Even though FDA approval is new, the American Congress of Obstetricians and Gynecologists has recommended since 2003 that doctors treat women at risk of premature birth with progesterone. Some physicians have been able to prescribe Makena even before the FDA gave the green light, by ordering a compounded version, but it will now be widely available. Official approval also means that insurance companies are more likely to cover the drug. (More on Time.com: Closely Spaced Pregnancies May Contribute to Autism)
About 30,000 U.S. women will be eligible for the drug each year, estimates Fleischman. If all of them were to receive the shot, 10,000 preterm births could be avoided annually, according to research by the National Institutes for Health, the U.S. Centers for Disease Control and Prevention and the March of Dimes. But that’s still a fairly small number when taking into account that each year more than 500,000 U.S. babies are born prematurely.
Prematurity is to blame for most infant deaths, and to date, there’s no silver bullet to protect against it. Makena alone isn’t likely to stanch the tide of preterm births because it isn’t the answer for all women who’ve previously had a premature baby; women can’t be pregnant with multiples, for example. They must have delivered a baby before 37 weeks because labor began too early on its own or because the membranes surrounding the baby ruptured too soon.
Prematurity costs the U.S. more than $26 billion a year, according to the Institute of Medicine. An increasing number of babies are being born too early for elective reasons — to accommodate schedules of doctors or mothers. In some hospitals, up to 40% of deliveries are scheduled early for no medical reason, resulting in some babies who need intensive care. (More on Time.com: Too Many Babies Are Delivered Too Early: Hospitals Should Just Say No)
“Preterm birth is a significant public health issue in the United States,” says Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”
But this isn’t the first time that a progesterone injection has been approved by the FDA. In 1956, the FDA approved hydroxyprogesterone caproate, then called Delalutin, for uses including in preventing miscarriage. It was withdrawn from the market in 2000 for business reasons.
For Fleming, from Charlotte, N.C., the progesterone shots meant she and her husband, Densel, did not have to re-enact the five months that Lauren was hospitalized. Lauren, now 7, has a younger sister and brother who both arrived at 39 weeks. Fleming credits medical interventions, including the injections, which she called a “very painful weekly occurrence.”
“The needle is huge and it hurts going in and for days after,” says Fleming. “But it was so worth it for me. That pain could not parallel the pain when Lauren was in the hospital. For me, it was a very small sacrifice.”