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Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

NCT00306462 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-11-09

No results posted yet for this study

Summary

Primary Hypothesis:

Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Conditions

  • Premature Birth
  • Premature Labor

Interventions

DRUG

Magnesium sulfate

Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is \< 6/hour.

DRUG

Oral Nifedipine or placebo

Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is \< 6/hour.

Sponsors & Collaborators

  • University Hospital

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Baha Sibai, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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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 NCT00306462 on ClinicalTrials.gov