CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 88 enrolled
Drug / intervention
Nifedipine +2 moredrug
Likely dose
Nifedipine 20 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/NCT02132533
NCT02132533Phase 3Completed
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Nifedipine for Acute Tocolysis of Preterm Labor

University of Texas Southwestern Medical Center·interventional·Posted May 7, 2014·Updated Dec 21, 2020

In Brief

A Phase 3 clinical trial evaluating Nifedipine, Placebo, and 1 other intervention for Preterm Labor. Completed, enrolled 88 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 7, 2014
Enrollment StartMay 5, 2014
Primary CompletionOct 29, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.2 years ago

Interventions

Nifedipinedrug

Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.

Placebodrug

Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.

Usual careother

Usual evaluation, monitoring and care for women with preterm labor.