Use of 17P Not Appropriate in Reducing All Preterm Births

A drug, 17P, approved by the FDA for use by mothers who had previously delivered a baby preterm, did not prevent preterm births for women in their first pregnancy who had a short cervix, according to the National Institutes of Health (NIH). Each year one in eight pregnancies end before the 37th week of pregnancy and are known as preterm. Some babies born before the 37th week have been shown to experience a number of health challenges.

 Not Effective for this Condition

 17P, or alpha-hydroxyprogesterone caproate, is a synthetic form of progesterone. The study, performed by the NIH, published in The American Journal of Obstetrics and Gynecology, on the use of 17P for women with a short cervix during their first pregnancy revealed that the use of this drug had no effect on preventing preterm births for women with this condition. A short cervix is defined at 30 millimeters or less and is known risk factor in the second trimester for preterm birth. More than 600 women who participated in the study were randomly given an injection of either 17P or a placebo. The study showed that the rates of preterm birth were about the same among the two groups of women.

 “This study shows the need to test 17P among different categories of women at risk for preterm delivery, rather than assuming that because it was shown to be effective in one group, that it would be effective in another,” said Catherine Y. Spong, M.D., and Associate Director for Extramural Research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded this study.

 Prior Approval

 17P was approved by the FDA in February of 2011 for use by women who had previously delivered a baby preterm. A study of the use of 17P for these women found that 37 percent of the women who were given 17P had a preterm birth while 55 percent of the women who were given the placebo had a preterm birth. The percentage of women that had a preterm birth who had been given 17P was even less for births before 35 weeks and even less for premterm births before 32 weeks.

 Preterm birth increases an infant’s risk of death as well as short-term and long-term complications such as breathing and vision problems, learning disabilities and cerebral palsy.