2004 Press Releases

New Study at Saint Barnabas Medical Center Aimed at Preventing Preterm Delivery

Livingston, N.J. -- Saint Barnabas Medical Center is the only hospital in New Jersey and one of only 15 hospitals nationally to be chosen for inclusion in a clinical trial aimed at preventing preterm delivery through the administration of vaginal progesterone. Leon Smith, Jr., M.D., Director of the Division of Maternal-Fetal Medicine at Saint Barnabas, is chief investigator; Veronica Ravnikar, M.D., Chair of the Department of Obstetrics and Gynecology, is co-investigator; with the participation of Judy Barry, R.N., nurse practitioner.

“Dr. Smith and I support evidenced-based medicine and are pleased to be participating in this study,” says Dr. Ravnikar. “It is important to do research to be sure that treatment is both adequate and effective.”

A New Delivery Method
In this Phase III randomized study, women who have a history of spontaneous preterm delivery will have either Prochieve® 8%, a progesterone gel, or a placebo placed in their cervix. Prochieve 8% delivers progesterone vaginally in an easy-to-use pre-filled, tampon-like applicator, and the product does not restrict normal activities. The treatment is given on a weekly basis to women whose last pregnancy resulted in a preterm birth at 35 weeks or less. Women with a smaller than average cervical length can also participate.

In a 2003 study published in The New England Journal of Medicine, it was reported that giving progesterone to pregnant women can reduce the risk of premature delivery by one third. In that study, the progesterone was delivered by injection. In the new clinical trial, Livingston-based Columbia Laboratories, Inc. is hoping to match orexceed the positive outcome of the previous study by using the gel instead of an intramuscular injection.
Prochieve 8% (progesterone gel) has been approved by the U.S. Food and Drug Administration for progesterone supplementation or replacement as part of treatment for infertile women with progesterone deficiency.

Important Research to Reduce Infant Mortality
The American College of Obstetricians and Gynecologists’ (ACOG) Committee on Obstetric Practice acknowledged the value of this research. The committee issued an opinion stating that progesterone may be used as treatment to help prevent preterm birth in women with a history of delivering prematurely.

In 2001, 11.9 percent of American babies were born before 37 weeks gestation. Premature birth is the second leading cause of infant mortality in the United States. The March of Dimes estimates that one in ten singleton babies born in the U.S. are born prematurely.

“We are hopeful that the study will result in an important potential treatment for women at risk for premature delivery, which is one of the most significant health concerns in obstetrics today," says. Dr. Smith. "The ability to demonstrate the safe use of a new therapy in the prevention of premature delivery would represent an important accomplishment."

Women interested in participating in the PROTERM study should contact The Division of Maternal-Fetal Medicine at (973) 322- 5287.

Date: November 14, 2004

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