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”
Condition Keyword(s):
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
Clinical Trials Authorship and Review
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