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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306462
Recruitment Status : Terminated (No enrollment in past year, lack of interest)
First Posted : March 23, 2006
Last Update Posted : November 9, 2009
University Hospital
Information provided by:
University of Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Premature Birth Premature Labor Drug: Magnesium sulfate Drug: Oral Nifedipine or placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity [ Time Frame: 4 years and 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306462

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

Publications of Results:
Other Publications:
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Responsible Party: Baha Sibai, MD/Professor, University of Cincinnati Identifier: NCT00306462     History of Changes
Other Study ID Numbers: 05-12-27-01
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: November 9, 2009
Last Verified: November 2009
Keywords provided by University of Cincinnati:
Premature Labor
Premature Birth
Magnesium sulfate
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents