New Options for Preventing Pre-Term Birth

The FDA is considering a marketing application from Watson Pharmaceuticals and Columbia Laboratories to approve its Prochieve 8% products for the prevention of pre-term births in women who have delivered early in the past.

The study identified women with a shorter cervix who are at risk for preterm birth actually had a 50% reduction in delivering before 33 weeks gestation. The cervical shortening was an established indicator of preterm delivery but the study also found birth outcomes to be more beneficial in this group as well. Respiratory distress syndrome is one of the most prevalent adverse effects of a preterm birth.  Further studies suggest that beyond the shorter cervix women who have had a preterm delivery in the past can also benefit from vaginal progesterone gel.

The other benefit to this therapy is that it is convenient, can be used easily by the patient and is less expensive than the current injection therapy.