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Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

This study has been completed.
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University Identifier:
First received: September 12, 2005
Last updated: May 25, 2016
Last verified: May 2016
To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Condition Intervention
Obstetric Labor, Premature Drug: Magnesium Sulfate Drug: Nifedipine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

Resource links provided by NLM:

Further study details as provided by Yasser Yehia El-Sayed, Stanford University:

Primary Outcome Measures:
  • No delivery in 48 hours and uterine quiescence [ Time Frame: 48 hours after administration of study medication. ]

Enrollment: 192
Study Start Date: April 1999
Study Completion Date: July 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium Sulfate
Preterm labor treatment with Magnesium Sulfate.
Drug: Magnesium Sulfate
Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
Active Comparator: Nifedipine
Preterm labor treatment with Nifedipine.
Drug: Nifedipine
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation

Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

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Please refer to this study by its identifier: NCT00185900

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

Additional Information:
Responsible Party: Yasser Yehia El-Sayed, Principle Investigator, Stanford University Identifier: NCT00185900     History of Changes
Other Study ID Numbers: 76145
Study First Received: September 12, 2005
Last Updated: May 25, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents processed this record on September 19, 2017