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TerminatedNCT00116623Updated Aug 15, 2016

Magnesium Sulfate Versus Indomethacin for Preterm Labor

A Phase 4 interventional study of Indomethacin and Magnesium sulfate in Labor, Premature, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-15.

Sponsored by University of Pennsylvania · Phase 4, Interventional, and Prevention

Why this study was terminated
Funding completed
Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Sex
Female
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Study summary

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.

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Conditions studied

  • Labor, Premature
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In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

Browse Obstetric Labor, Premature studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugIndomethacin
  • DrugMagnesium sulfate
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Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. PubMed 35947046 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00116623
Lead sponsor
University of Pennsylvania
First posted
Jun 30, 2005
Start date
Feb 2003
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Aug 15, 2016

Study contacts

George A Macones, M.D.
principal investigator · University of Pennsylvania
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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