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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315913
Recruitment Status : Terminated (Low study enrollment)
First Posted : April 19, 2006
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
Deborah A. Wing, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Dysfunctional Labor Drug: Propranolol Other: IV Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Randomized Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Dysfunctional Labor
Study Start Date : January 2004
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Vaginal delivery rates [ Time Frame: at time of delivery ]
  2. Cesarean section rates [ Time Frame: at time of cesarean rates ]

Secondary Outcome Measures :
  1. Neonatal outcomes [ Time Frame: at time of delivery ]
  2. Maternal safety [ Time Frame: assessed during labor ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315913

United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Leah R Battista, MD University of California, Irvine

Responsible Party: Deborah A. Wing, Professor and MFM Division Director, University of California, Irvine Identifier: NCT00315913     History of Changes
Other Study ID Numbers: HS #2004-3997
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Deborah A. Wing, University of California, Irvine:
Dysfunctional Labor
Labor Arrest
Primary Cesarean Section Prevention

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents