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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

September 12, 2005
June 10, 2011
November 2001
January 2007   (final data collection date for primary outcome measure)
Achieving 37 weeks gestation [ Time Frame: delivery ] [ Designated as safety issue: No ]
Achieving 37 weeks gestation
Complete list of historical versions of study NCT00185952 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of recurrent preterm labor
  • Neonatal outcomes
Not Provided
Not Provided
 
Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.
Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Obstetric Labor, Premature
  • Venous Thrombosis
Drug: Nifedipine
Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
  • Active Comparator: Nifedipine
    Maintenance tocolysis with nifedipine.
    Intervention: Drug: Nifedipine
  • Placebo Comparator: Placebo
    Maintenance tocolysis with placebo tablets.
    Intervention: Drug: Nifedipine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2008
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

- arrested preterm labor

Exclusion Criteria:

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

Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185952
76251
No
Yasser Yehia El-Sayed, Stanford University School of Medicine
Stanford University
Santa Clara Valley Health & Hospital System
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP