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

This study has been completed.

First Received on September 12, 2005. Last Updated on March 4, 2011 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00185900

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:

MedlinePlus related topics: Childbirth

Drug Information available for: Magnesium sulfate Nifedipine Magnesium

U.S. FDA Resources

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

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:

Obstet Gynecol. 2007 Jul;110(1):61-7. This link exits the ClinicalTrials.gov site

Publications:

Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7.

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 February 09, 2012