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Stanford/Packard study shows no benefit from drug widely used to prevent premature births
Date:11/25/2008

and hearing problems. The earlier the delivery, the greater the risks. That means doctors are very motivated to help women in early labor stay pregnant as long as possible. A recent survey by the Society for Maternal-Fetal Medicine found 29 percent of obstetricians prescribed drugs to keep such patients from re-entering early labor. Of those, 79 percent said nifedipine was their first-choice therapy.

Lyell's team recruited 71 women who had been successfully treated for preterm labor between 24 and 34 weeks of pregnancy. The women were then randomly assigned to receive doses of nifedipine or placebo every six hours until 37 weeks of pregnancy or until delivery, whichever came first. The researchers hoped nifedipine would prevent preterm labor from re-starting. They evaluated whether subjects' pregnancies lasted to 37 weeks and measured how long delivery was delayed. They also noted the babies' gestational age at delivery, birth weight and complications of prematurity.

The team saw no differences between nifedipine and placebo for any measurement. About 40 percent of women in both groups reached 37 weeks of pregnancy, with delivery delayed an average of a month. Babies' average health was the same in both groups, too.

Lyell cautioned that the study was designed to detect a 50 percent improvement in delayed deliveries. If nifedipine confers a smaller advantage, it would not have been spotted in this study, she said. Lyell thinks a larger study of nifedipine is warranted. "A small benefit would be especially significant at early gestational ages, and less so later on. But overall, there's no benefit to prematurity."

Based on the current lack of data to support this drug, Lyell believes obstetricians should proceed with caution. "All medications have side effects," she said. Though nifedipine has a fairly good safety record, a few case reports link it to dangerously low blood pressure in pregnant women.

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Contact: Erin Digitale
digitale@stanford.edu
650-724-9175
Stanford University Medical Center
Source:Eurekalert

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