CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 152 enrolled
Drug / intervention
17-alpha-hydroxy-progesterone caproate, Makena® +1 moredrug
Likely dose
17-alpha-hydroxy-progesterone caproate, Makena® 250mgfrom 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/NCT01119963
NCT01119963Phase 3Completed
CompareCT.gov

17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial

Obstetrix Medical Group·interventional·Posted May 10, 2010·Updated Jun 28, 2018

In Brief

A Phase 3 clinical trial evaluating 17-alpha-hydroxy-progesterone caproate, Makena® and Castor Oil (Placebo) for Preterm Delivery. Completed, enrolled 152 participants across 15 sites.

Detailed Summary

The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between randomization and delivery. 3. decrease neonatal morbidity.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2010
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago

Interventions

17-alpha-hydroxy-progesterone caproate, Makena®drug

Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.

Castor Oil (Placebo)drug

IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.