"The evidence of this treatment's effectiveness was so dramatic, the research was stopped early," said Meis, the national principal investigator and a professor of obstetrics and gynecology at Wake Forest. "This drug is readily available and can be used by doctors to improve outcomes for mothers and babies."
In women who received weekly injections of the drug 17-alpha-hydroxprogesterone caproate, also known as 17P, the risk of pre-term birth before the 37th week of pregnancy was reduced by 34 percent. The pre-term birth risk prior to 32 weeks was reduced by 42 percent.
"This is the first well-documented demonstration of a successful treatment to reduce pre-term births in women at risk," said Meis.
The study involved 463 women who had a history of giving birth before the 37th week of pregnancy. They were treated 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. In North Carolina, the other participating center was the University of North Carolina at Chapel Hill. Two-thirds of the women received weekly injections of 17P and one-third received a placebo or "dummy" drug. Treatment began at 16 to 18 weeks gestation and ended at 36 weeks.
The treatment was shown to be equally effective in African American and non-African American women.
The researchers originally planned to enroll 500 women, but enrollment was stopped early because of the drug's dramatic effectiveness. Earlier small studies had suggested that 17P therapy could help prevent pre-term birth, but no large tri
Contact: Karen Richardson
Wake Forest University Baptist Medical Center