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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.
Veronica Ravnikar, M.D., Chair of the Department of Obstetrics
and Gynecology, and Leon Smith, Jr., M.D., Director of the
Division of Maternal-Fetal Medicine at Saint Barnabas, are
co-investigators.
"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."
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, tamponlike 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 or exceed 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.
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.
"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.
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