CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 321 enrolled
Drug / intervention
17-alpha-hydroxyprogesterone caproate injectable +1 moredrug
Likely dose
17-alpha-hydroxyprogesterone caproate 250 mg intramuscularly once weekly from 16-23 weeks gestation until 34 weeks or delivery, whichever comes firstAI-extracted
Key inclusion· 5
  • ✓Twin pregnancy with dichorionic placentation OR triplet pregnancy with trichorionic placentation
  • ✓Gestational age 16 weeks 0 days to 23 weeks 6 days at randomization and injection initiation
  • ✓Maternal age 18 years or older
  • ✓Intact membranes
Key exclusion· 8
  • ✕Symptomatic uterine contractions in current pregnancy
  • ✕Contraindications to pregnancy prolongation including lethal fetal anomalies, amnionitis, preeclampsia, severe oligohydramnios, severe growth delay, or imminent fetal death
  • ✕Monochorionic placentation, major malformations, or certain medication exposures associated with major neonatal morbidity unrelated to preterm delivery
  • ✕Prior progesterone or progesterone-derivative use after 15 weeks gestation in current pregnancy

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

Search/NCT00163020
NCT00163020Phase 3Completed
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17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial

Obstetrix Medical Group·interventional·Posted Sep 13, 2005·Updated Apr 11, 2016

In Brief

A Phase 3 clinical trial evaluating 17-alpha-hydroxyprogesterone caproate injectable and Placebo for Preterm Birth. Completed, enrolled 321 participants across 18 sites.

Detailed Summary

Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: 1. Twin pregnancy 2. Triplet pregnancy

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartNov 1, 2004
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

17-alpha-hydroxyprogesterone caproate injectabledrug

250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.

Placebodrug

Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.