Magnesium Sulfate Versus Indomethacin for Preterm Labor

University of Pennsylvania

Status and phase: Terminated; Phase 4

Conditions: Labor, Premature

Treatments: Drug: Magnesium sulfate; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00116623

704914

Details and patient eligibility

About

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.

Sex: Female

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind