Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate
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.
Drug: 17 hydroxyprogesterone caproate intramuscular injections
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Delivery <37 weeks' gestation
- Delivery <34 weeks' gestation
- Delivery <32 weeks' gestation
- Neonatal outcomes
|Study Start Date:||July 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120640
|Principal Investigator:||Anna K Sfakianaki, MD||Yale University|
|Principal Investigator:||Edmund F Funai, MD||Yale University|