Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Abnormal Labor - Full Text View

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 Other: IV Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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 [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
Cesarean section rates [ Time Frame: at time of cesarean rates ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neonatal outcomes [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
Maternal safety [ Time Frame: assessed during labor ] [ Designated as safety issue: Yes ]

Enrollment:	2
Study Start Date:	January 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IV Propranolol IV dose propranolol	Drug: Propranolol IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg Other Name: Inderal
Placebo Comparator: IV Placebo IV Placebo of saline solution equal to propranolol in volume	Other: IV Placebo IV Saline Solution Other Name: Normal Saline

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.

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, 90806

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:	Pamela Rumney, RNC, Univeristy of California, Irvine Medical Center
ClinicalTrials.gov Identifier:	NCT00315913 History of Changes
Other Study ID Numbers:	HS #2004-3997
Study First Received:	April 17, 2006
Last Updated:	April 21, 2011
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
Obstetric Labor Complications
Pregnancy Complications
Propranolol
Oxytocin
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Oxytocics
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012