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

This study has been completed.

First Received: September 12, 2005 Last Updated: December 11, 2009 History of Changes

Sponsor:	Stanford University
Collaborator:	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 Venous Thrombosis	Drug: nifedipine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment
Official Title:	Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Resource links provided by NLM:

MedlinePlus related topics: Childbirth Deep Vein Thrombosis

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Achieving 37 weeks gestation [ Time Frame: delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of recurrent preterm labor [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Neonatal outcomes [ Time Frame: Discharge of neonate ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	November 2001
Study Completion Date:	August 2008
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
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:

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.

Responsible Party:	Stanford University School of Medicine ( Yasser Yehia El-Sayed )
Study ID Numbers:	76251
Study First Received:	September 12, 2005
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00185952 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Vasodilator Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Obstetric Labor, Premature
Physiological Effects of Drugs
Obstetric Labor Complications
Vascular Diseases
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents

Nifedipine
Thrombosis
Pharmacologic Actions
Membrane Transport Modulators
Embolism and Thrombosis
Tocolytic Agents
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010