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Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Primary Purpose

Obstetric Labor, Premature, Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor, Premature

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: - arrested preterm labor Exclusion Criteria: - ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nifedipine

Placebo

Arm Description

Maintenance tocolysis with nifedipine.

Maintenance tocolysis with placebo tablets.

Outcomes

Primary Outcome Measures

Achieving 37 weeks gestation

Secondary Outcome Measures

Incidence of recurrent preterm labor
Neonatal outcomes

Full Information

First Posted
September 12, 2005
Last Updated
June 10, 2011
Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System
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1. Study Identification

Unique Protocol Identification Number
NCT00185952
Brief Title
Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.
Official Title
Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor
Detailed Description
To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor, Premature, Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
Maintenance tocolysis with nifedipine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maintenance tocolysis with placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
Primary Outcome Measure Information:
Title
Achieving 37 weeks gestation
Time Frame
delivery
Secondary Outcome Measure Information:
Title
Incidence of recurrent preterm labor
Time Frame
Delivery
Title
Neonatal outcomes
Time Frame
Discharge of neonate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - arrested preterm labor Exclusion Criteria: - ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Yehia El-Sayed
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19037029
Citation
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.
Results Reference
result
PubMed Identifier
35947046
Citation
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.
Results Reference
derived

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Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

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