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

Primary Purpose

Dysfunctional Labor

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Propranolol

IV Placebo

About this trial

This is an interventional treatment trial for Dysfunctional Labor focused on measuring Labor, Dysfunctional Labor, Labor Arrest, Primary Cesarean Section Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Long Beach Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Propranolol

IV Placebo

Arm Description

IV dose propranolol

IV Placebo of saline solution equal to propranolol in volume

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00315913

First Posted

April 17, 2006

Last Updated

February 26, 2019

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT00315913

Brief Title

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

Official Title

Placebo-Controlled Randomized Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Dysfunctional Labor

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of feasibility

Study Start Date

January 2004 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysfunctional Labor

Keywords

Labor, Dysfunctional Labor, Labor Arrest, Primary Cesarean Section Prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV Propranolol

Arm Type

Experimental

Arm Description

IV dose propranolol

Arm Title

IV Placebo

Arm Type

Placebo Comparator

Arm Description

IV Placebo of saline solution equal to propranolol in volume

Intervention Type

Drug

Intervention Name(s)

Propranolol

Other Intervention Name(s)

Inderal

Intervention Description

IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg

Intervention Type

Other

Intervention Name(s)

IV Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

IV Saline Solution

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leah R Battista, MD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Long Beach Memorial Medical Center

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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