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Saturday, May 26, 2012

Study finds progesterone cuts rate of some premature births

Updated: August 4, 2011 4:20PM



Treating certain pregnant women who are at risk for delivering too early with progesterone — a naturally occurring hormone — cut their rate of giving birth prematurely nearly in half, a new study shows.

Babies born to women who were given a vaginal gel containing progesterone during pregnancy also were less likely to develop respiratory distress syndrome, a breathing disorder that often affects premature infants, researchers reported Wednesday in the medical journal Ultrasound in Obstetrics and Gynecology.

The women in the study had a condition known as short cervix. That puts them at higher risk for giving birth prematurely. About 2 percent of the 32,000 women initially screened for the multi-national study fell into that category. That average probably reflects women in the United States as a whole, lead study author Dr. Sonia S. Hassan said.

The results of the study from the National Institutes of Health are “another really important step in reducing rates of preterm birth,” said Dr. George Macones, a spokesman for the American College of Obstetricians and Gynecologists who was not involved in the research.

But Macones noted “we still have a long way to go” to prevent preterm birth outside of the relatively small subset of high-risk women included in the study.

Progesterone is produced by the ovaries and helps maintain pregnancy. Women with a short cervix are thought to have a shortage of the hormone. That could explain why the progesterone gel, called Prochieve, appears to lengthen pregnancy in these women, the researchers said.

The study involved 458 women randomly assigned to receive either a once-daily dose of the vaginal progesterone gel or a look-alike placebo during their second and third trimesters.

Of the women who were given progesterone, 8.9 percent gave birth before the 33rd week of pregnancy, compared with 16 percent of the placebo group. Babies born before week 37 are considered premature.

A short cervix can be detected with a transvaginal ultrasound — an exam that uses high-frequency sound waves to produce images of internal organs. Now that doctors have a way to prevent women with a short cervix from giving birth early, they should consider screening all pregnant women for the condition, Hassan said.

The maker of the Prochieve gel, Columbia Laboratories, and its marketing partner Watson Pharmaceuticals plan to apply to the federal Food and Drug Administration for approval of this new application of the drug later this year. A similar progesterone gel made by Columbia sells for $10 to $12 a dose, but it isn’t clear how much Prochieve might cost.

Rates of respiratory distress syndrome also were lower in infants whose mothers received progesterone during pregnancy — 3 percent vs. 8 percent.

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