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Magnesium Sulfate Versus Indomethacin for Preterm Labor

Primary Purpose

Labor, Premature

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Indomethacin
Magnesium sulfate
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor, Premature

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Initial episode of preterm labor for enrollment The diagnosis of preterm labor Gestational age between 24 and 32 weeks Singleton or twin gestation The ability to understand the requirements of the study Exclusion Criteria: Cervical dilation >5 cms Suspected chorioamnionitis Fetal distress Vaginal bleeding Severe pre-eclampsia History of gastrointestinal bleeding Abnormal renal function Suspicion of fetal malformation by ultrasound Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin Documented rupture of amniotic membranes Multiple gestations of triplets or more.

Sites / Locations

  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 29, 2005
Last Updated
August 12, 2016
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00116623
Brief Title
Magnesium Sulfate Versus Indomethacin for Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Initial episode of preterm labor for enrollment The diagnosis of preterm labor Gestational age between 24 and 32 weeks Singleton or twin gestation The ability to understand the requirements of the study Exclusion Criteria: Cervical dilation >5 cms Suspected chorioamnionitis Fetal distress Vaginal bleeding Severe pre-eclampsia History of gastrointestinal bleeding Abnormal renal function Suspicion of fetal malformation by ultrasound Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin Documented rupture of amniotic membranes Multiple gestations of triplets or more.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Macones, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
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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Magnesium Sulfate Versus Indomethacin for Preterm Labor

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