Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


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.


Study is Available At:


Original ID:

704914


NCT ID:

NCT00116623


Secondary ID:


Study Acronym:


Brief Title:

Magnesium Sulfate Versus Indomethacin for Preterm Labor


Official Title:


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Funding completed


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:George A Macones, M.D.
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:February 2003
Completion Date:February 2006
Completion Type:Actual
Primary Completion Date:February 2006
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 12, 2016
First Received Date:June 29, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Indomethacin
Intervention Type:Drug
Name:Magnesium sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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