Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Verified by: Stanford University, June 2011
First Received: September 12, 2005 | Last Updated: June 10, 2011 | Phase: N/A | Start Date: November 2001
Overall Status: Completed | Estimated Enrollment: 70
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Comparing nifedipine to placebo for the maintenance tocolysis of preterm...

Brief Summary

Official Title: “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 labor

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2007

Detailed Clinical Trial Description

To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.

Intervention(s) in this Clinical Trial

  • Drug: Nifedipine
    • Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Nifedipine
    • Maintenance tocolysis with nifedipine.
  • Placebo Comparator: Placebo
    • Maintenance tocolysis with placebo tablets.

Outcome Measures for this Clinical Trial

Primary Measures

  • Achieving 37 weeks gestation
    • Time Frame: delivery
      Safety Issue?: No

Secondary Measures

  • Incidence of recurrent preterm labor
    • Time Frame: Delivery
      Safety Issue?: No
  • Neonatal outcomes
    • Time Frame: Discharge of neonate
      Safety Issue?: No

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 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 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 February 12, 2012

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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