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Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185952
First Posted: September 16, 2005
Last Update Posted: June 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Incidence of recurrent preterm labor [ Time Frame: Delivery ]
  • Neonatal outcomes [ Time Frame: Discharge of neonate ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: June 13, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Obstetric Labor, Premature
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs