CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 174 enrolled
Drug / intervention
Intramuscular Progesterone +1 moredrug
Likely dose
Intramuscular Progesterone 250 mgfrom 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/NCT00579553
NCT00579553N/ACompleted
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Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.

University of Oklahoma·interventional·Posted Dec 24, 2007·Updated May 19, 2021

In Brief

A clinical study evaluating Intramuscular Progesterone and Vaginal Progesterone for Infant, Premature and Premature Birth. Completed, enrolled 174 participants across 1 site.

Detailed Summary

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes. Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Premature, Premature Birth
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.5 years ago

Interventions

Intramuscular Progesteronedrug

Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P

Vaginal Progesteronedrug

Vaginal Progesterone: 100 mg vaginal suppository daily