Magnesium Sulfate Versus Indomethacin for Preterm Labor

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116623

Enrollment

Unknown

Registered

2005-06-30

Start date

2003-02-28

Completion date

2006-02-28

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Premature

Brief 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.

Interventions

DRUGIndomethacin

DRUGMagnesium sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

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

* 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026