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

This study has been terminated.
(Low study enrollment)
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00315913
First received: April 17, 2006
Last updated: April 21, 2011
Last verified: April 2011
  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
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:


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
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, see Learn About Clinical Studies.

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 July 28, 2014