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NCT00116623 Clinical Trial

Magnesium Sulfate Versus Indomethacin for Preterm Labor

Labor, Premature Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00116623
Other study ID # 704914
Secondary ID
Status Terminated
Phase Phase 4
First received June 29, 2005
Last updated August 12, 2016
Start date February 2003
Est. completion date February 2006

Study information
Verified date August 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Indomethacin

• Magnesium sulfate

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT03171480 - Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia Phase 4
Completed NCT00397735 - N-acetylcysteine in Intra-amniotic Infection/Inflammation Phase 1/Phase 2
Completed NCT00209326 - A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor Phase 2
Terminated NCT03682822 - Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial N/A
Terminated NCT00137501 - Two Dose Regimens of Nifedipine for the Management of Preterm Labor Phase 3
Terminated NCT00641784 - Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population Phase 3
Withdrawn NCT01206998 - Vaginal Progesterone as a Treatment for Women Active Preterm Labor N/A
Completed NCT00599898 - Nifedipine Compared to Atosiban for Treating Preterm Labor Phase 4
Completed NCT00059683 - Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women N/A
Completed NCT00432250 - The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor. Phase 4
Not yet recruiting NCT04105881 - Correlation Between Vitamin D and B Regulatory Cell in Pregnancy