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 Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Indomethacin
• Drug: Magnesium sulfate

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00116623

Study ID Number: 704914

ClinicalTrials.gov Identifier: NCT00116623

Health Authority: United States: Institutional Review Board