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

Verified by: Stanford University, March 2011
First Received: September 12, 2005 | Last Updated: March 4, 2011 | Phase: N/A | Start Date: April 1999
Overall Status: Completed | Estimated Enrollment: 0
  • …
  • Tell a FriendPrint

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm...

Brief Summary

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

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2005

Intervention(s) in this Clinical Trial

  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Magnesium Sulfate
    • Preterm labor treatment with Magnesium Sulfate.
  • Active Comparator: Nifedipine
    • Preterm labor treatment with Nifedipine.

Outcome Measures for this Clinical Trial

Primary Measures

  • No delivery in 48 hours and uterine quiescence
    • Time Frame: 48 hours after administration of study medication.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Stanford University Other

Overall Clinical Trial Officials and Contacts

Yasser Yehia El-Sayed Principal Investigator Stanford University  

Related Publications

Citations Reporting Results

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.

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185900

Study ID Number: 76145

ClinicalTrials.gov Identifier: NCT00185900

Health Authority: United States: Institutional Review Board

Obstet Gynecol. 2007 Jul;110(1):61-7.

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00185900