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

This study has been terminated.

( Low study enrollment )

First Received: April 17, 2006 Last Updated: March 26, 2009 History of Changes

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00315913

Purpose

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.

Condition	Intervention	Phase
Dysfunctional Labor	Drug: Propranolol	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Placebo-Controlled Randomized Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Dysfunctional Labor

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Oxytocin Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Vaginal delivery rates
Cesarean section rates

Secondary Outcome Measures:

Number of doses
Neonatal outcomes
Maternal safety

Estimated Enrollment:	84
Study Start Date:	January 2004
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315913

Locations

United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Leah R Battista, MD

University of California, Irvine

More Information

No publications provided

Responsible Party:	Univeristy of California, Irvine Medical Center ( Pamela Rumney, RNC )
Study ID Numbers:	HS #2004-3997
Study First Received:	April 17, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00315913 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Labor
Dysfunctional Labor
Labor Arrest
Primary Cesarean Section Prevention

Additional relevant MeSH terms:

Dystocia
Vasodilator Agents
Neurotransmitter Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Oxytocics
Physiological Effects of Drugs
Obstetric Labor Complications
Reproductive Control Agents

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Oxytocin
Propranolol
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 08, 2010