CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
17-Hydroxyprogesterone Caproate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01050647
NCT01050647Phase 2Completed

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Stanford University·interventional·Posted Jan 15, 2010·Updated Apr 9, 2019

In Brief

A Phase 2 clinical trial evaluating 17-Hydroxyprogesterone Caproate and Caster Oil injections for Pregnancy Complications. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.5 years ago

Interventions

17-Hydroxyprogesterone Caproatedrug

Weekly injections of 17-hydroxyprogesterone caproate.

Caster Oil injectionsother

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.