Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor. - Full Text View

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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)

Arms	Assigned Interventions
Active Comparator: Nifedipine Maintenance tocolysis with nifedipine.	Drug: Nifedipine Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
Placebo Comparator: Placebo Maintenance tocolysis with placebo tablets.	Drug: Nifedipine Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.

Detailed Description:

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

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:	Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00185952 History of Changes
Other Study ID Numbers:	76251
Study First Received:	September 12, 2005
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obstetric Labor, Premature
Thrombosis
Venous Thrombosis
Obstetric Labor Complications
Pregnancy Complications
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Tocolytic Agents

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012