Premature Birth Clinical Trial
The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our goal is to evaluate whether or not progesterone is also effective in reducing preterm birth in symptomatic patients.
Preterm delivery remains one of the most important issues facing perinatal medicine today.
In 1999, prematurity/low birthweight accounted for 4,304 neonatal deaths, reflecting a rate
of neonatal mortality due to prematurity of 23.0 per 100,000 live births. Despite the extent
of the problem, the exact etiology of preterm delivery is not completely understood. It is
clear that many pathways are involved in preterm delivery, and that ultimately these must
converge upon one final endpoint, which is likely related to progesterone. In the animal
model progesterone withdrawal is clearly directly (rodent, rabbit) or indirectly (sheep)
involved in the initiation of parturition, however the exact way in which progesterone works
in humans is unclear. There has been a resurgence of interest in the association between
progesterone and preterm delivery. Two recent trials have looked at the utility of
progesterone in the prevention of preterm delivery in high-risk patients. In a multicenter
trial reported in the New England Journal of Medicine in 2003, Meis et al, recruited 463
patients with a history of spontaneous preterm delivery and randomized them in a 2:1 ratio
to intramuscular 17-hydroxyprogesterone vs. placebo from 16-20 weeks until 36 weeks.
Treatment with 17P significantly reduced the risk of delivery at <37 weeks, <35 weeks, and
<32 weeks.
The Yale Progesterone Study is a randomized, placebo-controlled trial of the use of 17
hydroxyprogesterone for the treatment of preterm labor. The design is similar to the Meis
NEJM trial, except that the patients will be symptomatic with preterm labor, rather than
asymptomatic with a history of preterm delivery. In addition to the therapeutic intervention
planned, the researchers intend to collect specimens to assess for markers of PTD, both
before and after treatment. In this way, the researchers can analyze which pathway of PTD is
involved, and finally, the effect of progesterone on these markers can be assessed.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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|---|---|---|---|
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