Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- arrested preterm labor

Exclusion Criteria:

- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00185952

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

Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine 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
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Obstetric Labor Complications
Pregnancy Complications
Vascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Tocolytic Agents
Vasodilator Agents processed this record on May 24, 2016