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Progesterone May Be Simple Solution to Reducing Rate of Premature Birth

One of the risk factors for having a premature baby is a short cervix, the part of a woman’s uterus that opens and shortens during labor. Now, researchers have found that treating women with the hormone progesterone reduces the rate of preterm birth before the 33rd week of pregnancy in women with a short cervix.

The National Institutes of Health study also found that infants born to mothers receiving progesterone treatment were less likely to develop respiratory distress syndrome, a breathing complication that often occurs in pre-term babies.

“The data demonstrates that treating women with premature cervical shortening with progesterone gel can significantly reduce the rate of early preterm birth and improve neonatal outcome,” said George Creasy, MD, FACOG, Vice President of Columbia Laboratories, Inc., the makers of PROCHEIVE bioadhesive vaginal progesterone gel. Columbia collaborated with NIH on the study, which was undertaken by physicians in the Perinatology Research Branch at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, as part of the 44 medical centers around the world.

Preterm delivery refers to the birth of a baby of less than 37 weeks. In 2008, 12.3 percent of U.S. infants were born preterm, which puts them at increased risk for death during the first year of life, as well as breathing difficulties, cerebral palsy, learning disabilities, blindness and deafness.

“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, M.D., 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.”

Progesterone is a naturally occurring hormone that is essential to maintaining a pregnancy. A short cervix may be a sign of a possible shortage of the hormone, thus researchers theorized that adding a supplement could prolong the pregnancy. The study looked at 458 women with short cervixes who were randomly assigned either the vaginal progesterone gel or a placebo between the 19th and 23rd week of pregnancy. The hormone reduced the rate of preterm birth before the 33rd week of pregnancy by 45 percent.

Columbia Laboratories is planning to file a New Drug Application (NDA) for PROCHEIVE for this indication by the end of June, according to Dr. Creasy. “If approved by the FDA, we believe mid-pregnancy cervical screening, followed by treatment of patients identified as having premature cervical shortening with PROCHIEVE, may lead to significant clinical benefits, improved infant outcome and subsequent savings to the health care system.”