Progesterone Gel Reduces Rate of Premature Birth by 45 Percent

April 7, 2011— -- The medical community was sent into an uproar recently when KV Pharmaceuticals jacked up the price of 17P, one of the only drugs currently approved to treat preterm birth. But hope for a new, affordable alternative treatment for certain women at risk of preterm delivery may be on the horizon thanks to new research from the National Institutes of Health.

Unlike 17P, which delivers synthetic progesterone by injection, the drug in question is a naturally-derived progesterone gel applied vaginally. According to results published Wednesday by the NIH, the gel reduced the rate of preterm birth by 45 percent in women identified as having a short cervix, one of many risk factors for premature delivery.

One of the hardest parts of predicting and treating preterm birth is that early delivery can occur for a number of reasons, and each may require different treatment approaches, says lead author on the study, Dr. Roberto Romero, program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch.

One risk factor is having had a preemie baby already -- the risk factor that makes a woman eligible for 17P. The problem is, about 60 percent of preterm babies come from a mother who does not have a history of preterm birth, so "the question becomes, how else can we assess risk?" says Romero.

This is where testing for a short cervix comes in. Using a simple ultrasound, doctors can screen for a short cervix during pregnancy and identify a woman as at risk for preterm birth. By daily applying the gel, which currently costs between $10 and $15 and is prescribed during in vitro fertilzation, the rate of these preterm births before the 33rd week of pregnancy can be nearly cut in half. Though this will only address a small portion of all the preterm births, Romero says that this study argues for universal screening of cervix length to prevent what he estimates will be thousands of premature births annually in the U.S.