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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185900
First received: September 12, 2005
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Stanford University:

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

Enrollment: 0
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185900

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

Additional Information:
Publications:
Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185900     History of Changes
Other Study ID Numbers: 76145
Study First Received: September 12, 2005
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
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 September 18, 2014