- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116623
Magnesium Sulfate Versus Indomethacin for Preterm Labor
August 12, 2016 updated by: University of Pennsylvania
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: George A Macones, M.D., University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
June 29, 2005
First Submitted That Met QC Criteria
June 29, 2005
First Posted (Estimate)
June 30, 2005
Study Record Updates
Last Update Posted (Estimate)
August 15, 2016
Last Update Submitted That Met QC Criteria
August 12, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Gout Suppressants
- Tocolytic Agents
- Magnesium Sulfate
- Indomethacin
Other Study ID Numbers
- 704914
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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