Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: March 4, 2011
Last verified: March 2011
To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor
|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:
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 ]
|Study Start Date:||April 1999|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
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.
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185900
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
Sponsors and Collaborators
|Principal Investigator:||Yasser Yehia El-Sayed||Stanford University|