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Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized, Double Blind Trial
This study has been completed.
Sponsors and Collaborators: Stanford University
Santa Clara Valley Health & Hospital System
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00185952
  Purpose

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor


Condition Intervention
Obstetric Labor, Premature
 Drug: nifedipine

MedlinePlus related topics: Childbirth
Drug Information available for: Nifedipine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title: Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Achieving 37 weeks gestation

Secondary Outcome Measures:
  • Incidence of recurrent preterm labor
  • Neonatal outcomes

Estimated Enrollment: 0
Study Start Date: November 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • arrested preterm labor

Exclusion Criteria:

  • ruptured membranes
  • fetal distress
  • placenta previa
  • placental abruption
  • maternal medical contraindication to tocolysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185952

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

Publications indexed to this study:
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.

Study ID Numbers: 76251
Study First Received: September 12, 2005
Last Updated: March 21, 2008
ClinicalTrials.gov Identifier: NCT00185952  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Calcium, Dietary
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Nifedipine

Additional relevant MeSH terms:
Membrane Transport Modulators
Vasodilator Agents
Tocolytic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
 Physiological Effects of Drugs
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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