Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00120640
Study type	Interventional
Source	Yale University
Contact
Status	Withdrawn
Phase	N/A
Start date	July 2005

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Active, not recruiting	`NCT03655639` - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT03337659` - A Cluster Randomized Controlled Trial of FICare at 18 Months	N/A
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Completed	`NCT03251729` - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix	Phase 4
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02913495` - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth	Phase 4
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Not yet recruiting	`NCT02880696` - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates	N/A
Completed	`NCT02879799` - Family Integrated Care (FICare) in Level II NICUs	N/A
Completed	`NCT02661360` - Effects of Swaddling on Infants During Feeding	N/A
Completed	`NCT02743572` - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants	N/A
Completed	`NCT01352234` - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia	Phase 4
Completed	`NCT01163188` - Social Adjustment and Quality of Life After Very Preterm Birth	N/A
Terminated	`NCT00675753` - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families	N/A
Terminated	`NCT00179972` - Evaluation of Pulse Oximetry Sensors in Neonates	N/A