The study was undertaken by physicians of the Perinatology Research Branch at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) along with 44 medical centers around the world (including Asia, Africa, Europe, North and South America). The study was a collaboration between the NIH and Columbia Laboratories, Inc., in Livingston, New Jersey.
Vaginal gel could reduce the rate of preterm birth in women with short cervixes
“Our study demonstrates that progesterone gel reduces the rate of early preterm delivery — less than 33 weeks — in women with a short cervix,” said Roberto Romero, MD, program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch. “Women with a short cervix can be identified through routine ultrasound screening. Once identified, they could be offered treatment with progesterone.”
Dr Romero explained that progesterone is a naturally-occurring hormone which is essential to maintain pregnancy, and that a short cervix is thought to be a sign of a possible shortage of progesterone.
The study authors reasoned that by giving progesterone to women with a short cervix, they could, in many cases, prolong pregnancy.
A total of 458 women with a short cervix (10-20 millimeters) were randomly assigned to receive either a vaginal gel progesterone preparation or a placebo between the 19th and 23rd week of pregnancy. The National Institutes of Health study was published online in Ultrasound in Obstetrics and Gynecology in April 2011.
Progesterone treatment was associated with a lower rate of preterm delivery at less than 33 weeks (8.9 percent in the progesterone group versus 16.1 percent in the placebo group). Differences in the rate of preterm birth were also seen in births before 28 and 35 weeks of pregnancy.
Born before 28 weeks
Born before 35 weeks
Infants born to women who received progesterone had a lower rate of respiratory distress syndrome than those in the placebo group (3 percent versus 7.6 percent).