Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

Summary

The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours, decrease maternal side effects and decrease some complications related to preterm delivery to the neonate. Both of these medications are commonly used to stop pre-term labor, therefore it has become our institution's standard to use these two medications in the setting of preterm labor. There have been limited studies comparing these two medications directly.

A total of 450 participants will be asked to participate across all study sites.

Conditions

• Obstetric Labor, Premature

Interventions

DRUG

Nifedipine

Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.

DRUG

Indomethacin

Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, Irvine

  lead OTHER

Principal Investigators

• Deborah A Wing, MD · University of California, Irvine

• Mary Norton, MD · University of California, San Francisco

• Gladys (Sandy) Ramos, MD · University of California, San Diego

• Aisling Murphy, MD · University of California, Los Angeles

• Veronique Tache, MD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-17

Primary Completion

2019-04-18

Completion

2019-04-18

Countries

• United States

Study Locations