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NCT00185952 Clinical Trial

Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Venous Thrombosis Clinical Trial

Official title:
Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185952
Other study ID # 76251
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated June 10, 2011
Start date November 2001
Est. completion date August 2008

Study information
Verified date June 2011
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 2008
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- arrested preterm labor

Exclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine
Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University Santa Clara Valley Health & Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1097/AOG.0b013e31818d8386. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Achieving 37 weeks gestation delivery No
Secondary Incidence of recurrent preterm labor Delivery No
Secondary Neonatal outcomes Discharge of neonate No
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