Back to resultsMagnesium 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
About this trial
This is an interventional prevention trial for Labor, Premature
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.
Sites / Locations
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00116623
First Posted
June 29, 2005
Last Updated
August 12, 2016
Sponsor
University of Pennsylvania
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
Learn more about this trial
Magnesium Sulfate Versus Indomethacin for Preterm Labor
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