A new vaginal gel, containing the hormone progesterone and manufactured by Columbia Laboratories Inc. and Watson Pharmaceuticals Inc., reduces the rate of premature delivery in women with a short cervix by 45 percent. The results from a late-stage study, published in the journal Ultrasound in Obstetrics and Gynecology, looked at 458 pregnant women with the condition known as short cervix and gave them either the gel, called Prochieve, or a placebo between the 19th and 23rd week of pregnancy. A significant reduction in the frequency of early labor was noted: 9 percent of women who received the gel delivered before their 33rd week of pregnancy, compared to 16 percent in the placebo group.
Unlike Makena, a recently FDA approved injection made by KV Pharmaceuticals Inc. aimed at preventing premature birth in women who’ve already had a preemie and are pregnant again, Prochieve is only intended to prevent premature delivery in first-time mothers.
There are many factors that contribute to premature birth, and short cervix is one of them, which is a condition that can occur in approximately 2.3 percent of pregnancies, affecting 100,000 U.S. women annually.
Each year, 500,000 premature babies are born in the U.S., and according to ACSH's Dr. Gilbert Ross, early labor and delivery — prior to 36 weeks gestation — is associated with many serious, even life-threatening complications in the newborn. Most feared is respiratory distress syndrome, but developmental problems, cerebral palsy and many other conditions take a heavy toll among such early-delivered “preemies.”
In addition to reducing early delivery, Prochieve also reduced the incidence of respiratory distress in the newborns, by over 50 percent. Those whose mothers received the gel had a 3 percent incidence of respiratory distress, while the control-group newborns had a rate of 7.6 percent.
“Given that a significant number of babies are born preterm every year, hopefully this new vaginal gel, which is still seeking FDA approval, will help more new mothers give birth to healthier newborns,” says Dr. Ross.