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

This study has been terminated.
(Low study enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315913
First Posted: April 19, 2006
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Deborah A. Wing, University of California, Irvine
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Deborah A. Wing, University of California, Irvine:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Deborah A. Wing, Professor and MFM Division Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00315913     History of Changes
Other Study ID Numbers: HS #2004-3997
First Submitted: April 17, 2006
First Posted: April 19, 2006
Last Update Posted: November 8, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Propranolol
Oxytocics
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