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By Nancy Menefee Jackson, HealthAtoZ contributing writer
There is new hope for women with a history of miscarriage or pre-term delivery.
A generic progesterone-type hormone that's been used for years to treat infertility proved so dramatically effective at preventing pre-term births that a study was halted.
The drug is known as 17P, which stands for 17-alpha-hydroxprogesterone caproate. It uses a natural progesterone that is synthesized with caproate.
The study involved 463 women with a history of pre-term births. The trial was held at 19 centers that are members of the Maternal Fetal Medicine Units Network of the National Institute of Child Health and Human Development at the National Institutes of Health.
Paul J. Meis, M.D., the national principal investigator and a professor at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., reported on the study at the annual meeting of the Society for Maternal-Fetal Medicine held in February 2003.
"This particular metabolite seems to have a special effectiveness. There have been other trials of progesterone that were not successful," Meis says.
The study enrolled women who had had previous spontaneous births before 37 weeks. (Full term delivery is 37 to 42 weeks.) The women's average pre-term delivery time was 30 to 31 weeks, and many had had more than one pre-term birth.
"It turns out this was a pretty high-risk group of women," Meis says.
In the study, the women were given weekly injections of 17P beginning between the 16th and 21st weeks of their pregnancy up to their 37th week of pregnancy.
The risk of pre-term births before the 32nd week was reduced by 42 percent, and the risk of birth before the 37th week was reduced by 34 percent. These dramatic results called for the study to be halted, since the drug is readily available to doctors.
"All of these large trials have data monitoring and safety committees which review the progress of trials," Meis says, "and after 350 women had delivered, they found such a positive outcome of the trial they recommended we stop enrolling women."
Meis speculates the drug works so well in part because it is known to quiet the smooth muscles of the uterus and inhibits uterine contractions. The only side effect the women experienced was a localized reaction at the injection site. Nor did researchers find any long-term effects on the developing fetus. The drug proved equally effective for African-American women as non-African American women. This is important because there is a two-fold higher rate of pre-term births in African Americans.
"This drug has been around a long time, used in women with infertility and to prevent miscarriage, and there are no androgen-like effects," Meis says. "We did a very thorough search of the literature and we couldn't find a thing."
Using an already-approved drug for something else is what is known as an off-label use; the drug is approved by the FDA for other uses, but can be prescribed by doctors for a condition not indicated in the drug's labeling.
This article was reviewed and updated June 2007.
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