Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized, Double Blind Trial

Comparing nifedipine to placebo for the maintenance tocolysis of preterm...

Date First Received: September 12, 2005

Last Updated: March 20, 2009

Verified by: Stanford University, March 2009

Clinical Trial Phase: N/A | Start Date: November 2001

Overall Status: Completed

Estimated Enrollment: 70

Brief Summary

Official Title: “Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial”

Intervention(s):

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

  • Drug: nifedipine

Outcome Measures for this Clinical Trial

Primary Measures

  • Achieving 37 weeks gestation

Secondary Measures

  • Incidence of recurrent preterm labor
  • Neonatal outcomes

Criteria for Participation in this Clinical Trial

  • Inclusion Criteria:- arrested preterm labor
  • Exclusion Criteria:- ruptured membranes, fetal distress, placenta previa, placental abruption, 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: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Stanford University

Overall Clinical Trial Officials and Contacts

Yasser Yehia El-Sayed Principal Investigator Stanford University  

Related Publications

Citations Reporting Results

Lyell DJ, Pullen KM, Mannan J, Chitkara U, Druzin ML, Caughey AB, El-Sayed YY. Maintenance nifedipine tocolysis compared with placebo: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1221-6.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185952

Study ID Number: 76251

ClinicalTrials.gov Identifier: NCT00185952

Health Authority: United States: Institutional Review Board

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