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
1 other identifier
interventional
70
1 country
1
Brief Summary
Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJune 13, 2011
June 1, 2011
5.2 years
September 12, 2005
June 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Achieving 37 weeks gestation
delivery
Secondary Outcomes (2)
Incidence of recurrent preterm labor
Delivery
Neonatal outcomes
Discharge of neonate
Study Arms (2)
Nifedipine
ACTIVE COMPARATORMaintenance tocolysis with nifedipine.
Placebo
PLACEBO COMPARATORMaintenance tocolysis with placebo tablets.
Interventions
Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
Eligibility Criteria
You may qualify if:
- \- arrested preterm labor
You may not qualify if:
- \- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Santa Clara Valley Health & Hospital Systemcollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
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):1221-1226. doi: 10.1097/AOG.0b013e31818d8386.
PMID: 19037029RESULTWilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PMID: 35947046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasser Yehia El-Sayed
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
November 1, 2001
Primary Completion
January 1, 2007
Study Completion
August 1, 2008
Last Updated
June 13, 2011
Record last verified: 2011-06