NIH study shows drug fails to prevent preterm birth in high risk group

No benefit seen for progesterone drug for first-time mothers with a short cervix

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2012-10-18

A formulation of the hormone progesterone, shown to be effective in women at risk for another preterm birth because they had a prior preterm birth, was not found to be effective in preventing preterm birth for women in their first pregnancy who have a short cervix, according to a National Institutes of Health network study.

Each year, 1 in 8 infants is born preterm in the United States. Preterm birth increases an infant's risk of death and survivors’ risk of short- and long-term complications such as breathing and vision problems, learning disabilities and cerebral palsy.

In February 2011, the U.S. Food and Drug Administration approved the use of 17 alpha-hydroxyprogesterone caproate (17P), a synthetic form of progesterone, to reduce the chances of preterm birth in women pregnant with a single fetus who had delivered a single infant early in a previous pregnancy.

Like preterm delivery in a previous pregnancy, a short cervix in the second trimester is a known risk factor for preterm birth. The cervix is part of the neck of the uterus, which becomes shorter as labor approaches.

For the current study, the researchers assessed whether 17P given to first-time mothers found to have a short cervix would prevent delivery before 37 weeks of gestation. In this study, short cervical length was defined as a cervical length at or below the 10th percentile (30 millimeters or less).

More than 600 women participated in the study. The women were assigned at random to receive either 17P or a placebo. The researchers found that rates of preterm birth were about the same among women who received a weekly injection of 17P and those who received a placebo.

Source: U.S. National Institutes of Health