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

This study has been terminated.
(No enrollment in past year, lack of interest)
Sponsor:
Collaborator:
University Hospital
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00306462
First received: March 21, 2006
Last updated: November 6, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Premature Birth
Premature Labor
 Drug: Magnesium sulfate
Drug: Oral Nifedipine or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity [ Time Frame: 4 years and 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: March 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous magnesium sulfate or placebo
 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.
Active Comparator: 2
Oral nifedipine or placebo
 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.
Other Name: Oral procardia

Detailed Description:

Primary Objective:

To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at <37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.

Secondary Objective:

  1. To compare maternal side effects between the two tocolytic agents
  2. To compare neonatal morbidities between the two study groups.
  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.

Exclusion Criteria:

  • Cervical dilatation of ≥ 6 cm
  • Maternal contraindication to tocolysis
  • Known fetal anomalies
  • Suspected chorioamnionitis
  • Nonreassuring fetal heart tracing
  • Vaginal bleeding due to placenta previa or abruptio placenta
  • Preterm premature rupture of membranes
  • Prolapsed membranes
  • Human immunodeficiency virus positive
  • Multiple gestation
  • Patients on procardia within 24 hours of po intake
  • Magnesium sulfate tocolysis prior to randomization
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306462

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
University Hospital
Investigators
Principal Investigator: Baha Sibai, MD University of Cincinnati
  More Information

Publications:

Responsible Party: Baha Sibai, MD/Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00306462     History of Changes
Other Study ID Numbers: 05-12-27-01
Study First Received: March 21, 2006
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Premature Labor
Premature Birth
Magnesium sulfate
Nifedipine

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Nifedipine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013