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Magnesium Sulfate Versus Indomethacin for Preterm Labor

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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