Trial of Oxytocin Alone Versus Oxytocin and Propranolol f... | NCT00315913

Studies
Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Abnormal Labor

NCT00315913

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Feb 27, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Dysfunctional Labor

Interventions

Propranolol
IV Placebo

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of feasibility

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Apr 17, 2006

First Submission Date that Met QC Criteria

Apr 17, 2006

First Posted Date

Apr 19, 2006Estimated

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

Feb 26, 2019

Last Update Posted Date

Feb 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deborah A. Wing, Professor and MFM Division Director, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether propranolol is better than oxytocin for the treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by women receiving prolonged oxytocin versus propranolol.

Detailed Description

This trial was designed to test if propranolo can reduce the c section rate for dysfuctional labor. Due to stringent inclution and exclusion criteria and low enrollment the study was closed.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV Propranolol	Experimental	IV dose propranolol	Drug: Propranolol
IV Placebo	Placebo Comparator	IV Placebo of saline solution equal to propranolol in volume	Other: IV Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propranolol	Drug	IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg	IV Propranolol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be term pregnancy (> 37 weeks)
Vertex presentation
Active labor (4-5 centimeters dilated)

Exclusion Criteria:

Heart disease
Diabetes
Currently taking propranolol
Contraindications to labor or vaginal delivery
Multiple gestations
Preterm
Chorioamnionitis

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leah R Battista, MD	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Beach Memorial Medical Center		Long Beach	California	90806	United States

Condition Browse Module

MeSH Terms

ID	Term
D004420	Dystocia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011433	Propranolol
D000077330	Saline Solution

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided