Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120640
Status:
WITHDRAWN
Last Update Posted:
2012-09-19
First Post:
2005-07-11
Brief Title:
Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Preterm delivery remains one of the most important issues facing perinatal medicine today In 1999 prematuritylow birthweight accounted for 4304 neonatal deaths reflecting a rate of neonatal mortality due to prematurity of 230 per 100000 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 21 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None