Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

NCT ID: NCT00185952

Last Updated: 2011-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Labor, Premature Venous Thrombosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nifedipine

Maintenance tocolysis with nifedipine.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

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

Placebo

Maintenance tocolysis with placebo tablets.

Group Type PLACEBO_COMPARATOR

Nifedipine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nifedipine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- arrested preterm labor

Exclusion Criteria

\- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Santa Clara Valley Health & Hospital System

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stanford University School of Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 19037029 (View on PubMed)

Wilson 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.

Reference Type DERIVED
PMID: 35947046 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

76251

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nifedipine Treatment in Preterm Labor
NCT01314859 WITHDRAWN PHASE3
Bryophyllum vs. Nifedipine
NCT00391339 UNKNOWN PHASE2/PHASE3