Celebrex may be safe for preterm labor, preliminary study finds

September 23, 2002

St. Louis, Sept. 23, 2002 -- The drug celecoxib may be a safer alternative for treating preterm labor than traditional therapies, according to a preliminary study led by Washington University School of Medicine in St. Louis. The study is published at the end of the month in the September issue of the American Journal of Obstetrics and Gynecology, and appears on the journal's website today.

One of the established treatments to prevent preterm delivery is indomethacin, a drug used to slow uterine contractions and delay delivery. But indomethacin is associated with severe side effects. Recent research suggests that celecoxib, also known as celebrex, may be a safer alternative. This study is the first clinical trial testing celecoxib in pregnant women.

"Celecoxib appears to be safer, particularly for the fetus," says Yoel Sadovsky, M.D., director of the Division of Genetics, Maternal-Fetal Medicine and Ultrasound at the School of Medicine. "These preliminary results also suggest that celecoxib is just as effective, and we are currently planning a larger trial to further examine its effectiveness."

The study was a combined effort between Washington University and Northwestern University. Sadovsky, also associate professor of obstetrics and gynecology and of cell biology and physiology, led the study. The first authors are Catherine S. Stika, M.D., at Northwestern University and Gilad A. Gross, M.D., assistant professor of obstetrics and gynecology at Washington University.

According to the American College of Obstetrics and Gynecology, about 1 in every 10 births in the United States occurs within the first 37 weeks of pregnancy and therefore is considered "preterm." Preterm labor is responsible for about 75 percent of newborn deaths not related to birth defects, and preterm infants often experience life-long complications.

Indomethacin, one of the standard drugs used to treat preterm labor, prevents the production of a type of protein called cyclo-oxygenase (COX), which is thought to play a critical role in the onset of preterm labor. Recently, however, several research teams including the Washington University group discovered that women in preterm labor have abnormally high levels of only one type of COX protein, COX-2. The team therefore theorized that a drug like celecoxib, which influences only COX-2, may effectively treat preterm labor with fewer side effects, since the drug only targets one protein.

Twenty-four women older than 18 who went into labor between 24 and 34 weeks of pregnancy were treated with either celecoxib or indomethacin. They all were admitted to Washington University's clinical affiliate, Barnes-Jewish Hospital, or to Northwestern University's affiliate, Northwestern Memorial Hospital. The women were randomly assigned to one of the two treatment groups. The team examined the health of the mothers and fetuses until delivery.

The team found the two drugs equally safe for mothers, but celecoxib was safer for fetuses than indomethacin. For example, indomethacin significantly increased the constriction of a major blood vessel in fetuses, the ductus arteriosus, while there was no significant change in the celecoxib group. Also, the volume of amniotic fluid in the indomethacin group was less than in the celecoxib group 24 hours and 48 hours after the first treatment. Blood tests confirmed that celecoxib interfered only with COX-2, while indomethacin also disrupted another COX protein.

According to Sadovsky, "If further testing verifies the safety and effectiveness of celecoxib, we could have a new drug to treat women who are at risk for preterm delivery."
Stika CS, Gross GA, Leguizamon G, Gerber S, Levy R, Mathur A, Bernhard LM, Nelson DM, Sadovsky Y. A prospective randomized safety trial of celecoxib for treatment of preterm labor. American Journal of Obstetrics and Gynecology, vol.187, September 2002

Internal funds from the Departments of Obstetrics and Gynecology at Washington University School of Medicine in St. Louis and Northwestern University supported this research.

The full-time and volunteer faculty of Washington University School of Medicine are the physicians and surgeons of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

Washington University School of Medicine

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