Magnesium Sulfate Versus Indomethacin for Preterm Labor | NCT00116623

Studies
Magnesium Sulfate Versus Indomethacin for Preterm Labor

NCT00116623

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Aug 15, 2016Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Labor, Premature

Interventions

Indomethacin
Magnesium sulfate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding completed

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jun 29, 2005

First Submission Date that Met QC Criteria

Jun 29, 2005

First Posted Date

Jun 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2016

Last Update Posted Date

Aug 15, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George A Macones, M.D.	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35947046	Derived	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.

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
Indomethacin	Drug
Magnesium sulfate	Drug