MedTrace Logo

Nifedipine for Acute Tocolysis of Preterm Labor

NCT02132533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-12-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Preterm Labor

Interventions

DRUG

Nifedipine

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.

DRUG

Placebo

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

OTHER

Usual care

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Brian M Casey, MD · Department of Alabama Medical Center, Birmingham, AL

  • Donald D McIntire, PhD · University of Texas Southwestern Medical Center

  • Kenneth J Leveno, MD · University of Texas Southwestern Medical Center

  • Chet E Wells, MD · University of Texas Southwestern Medical Center

  • Josiah S Hawkins, MD · Kaiser Medical Center, Oakland, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-05
Primary Completion
2018-10-29
Completion
2018-10-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02132533 on ClinicalTrials.gov