Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

This study has been completed.
Sponsor:
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185952
First received: September 12, 2005
Last updated: June 10, 2011
Last verified: June 2011
  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:


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
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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:
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
Venous Thromboembolism
Obstetric Labor Complications
Pregnancy Complications
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014