Progesterone gel may improve infant outcomes in high-risk pregnancies

Researchers at the School of Medicine and elsewhere have shown that babies born to women with high-risk pregnancies treated with a vaginal progesterone gel appear to be less likely to need intensive care than babies born to mothers treated with a placebo.

The study, led by Emily DeFranco, D.O., clinical fellow of maternal-fetal medicine in the Department of Obstetrics and Gynecology, is the first associated with statistically significant improvements in clinically important measures of infant outcomes. It was published in the October issue of Ultrasound in Obstetrics & Gynecology.

Researchers conducted an analysis of data from the largest single-child preterm birth prevention study with progesterone by looking at a group of 46 women with high-risk pregnancies because they had a short cervix (less than 2.8 centimeters). They found that only one out of six newborns, or 16 percent, of mothers treated with vaginal progesterone gel, Prochieve 8 percent, needed to be admitted to a neonatal intensive care unit compared with 52 percent newborns of mothers treated with a placebo. In addition, they found that infants born to mothers treated with vaginal progesterone gel who were admitted to intensive care units spent an average of one day in intensive care compared with more than two weeks for those babies of mothers who received a placebo.

Additional studies are being planned to repeat this finding.

Progesterone is a natural hormone found in all women, though levels of progesterone increase during pregnancy. The gel often is used to help sustain pregnancy in the first trimester.

The study also showed that treatment with vaginal progesterone gel may reduce early preterm birth among women with a short cervix. A normal pregnancy is about 40 weeks. Preterm birth before 37 weeks gestation, a leading cause of infant and neonatal death, continues to rise and occurs in more than 12 percent of pregnancies in the United States.

“When looking at a sample of 46 women with a short cervix of less than 2.8 centimeters, none of those who were started on vaginal progesterone gel between 18-22 weeks of gestational age delivered prior to 32 weeks of gestation, while almost one-third of women with a shortened cervix given a placebo delivered prior to 32 weeks of gestation,” DeFranco said.

“Additionally, the number of admissions and days spent in the neonatal intensive care unit for babies whose moms were given vaginal progesterone gel were significantly lower than for those whose moms received a placebo,” she said.

“We’re excited about these promising clinical implications, especially if confirmed in a larger study,” DeFranco said.