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The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409890
First Posted: December 12, 2006
Last Update Posted: December 12, 2006
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:
University Hospital of the West Indies
  Purpose
To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.

Condition Intervention Phase
Labor Stage, First Drug: Hyoscine Butyl Bromide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies

Resource links provided by NLM:


Further study details as provided by University Hospital of the West Indies:

Primary Outcome Measures:
  • To assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor.

Secondary Outcome Measures:
  • To determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.

Estimated Enrollment: 120
Study Start Date: June 2005
Estimated Study Completion Date: October 2005
Detailed Description:

Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals here in Jamaica, as it has elsewhere in the world. Thus, it represents a new addition to the armamentarium of active management. The mechanism by which it acts in the context of labor has not yet been elucidated, and the evidence for its efficacy was previously largely anecdotal. The specific objectives of this project are to assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor. We also intend to determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.

The study was designed as a double blind, randomized, controlled, clinical trial comparing two groups of patients matched for age and parity. One group of patients received the 20 mg(1 ml)of hyoscine butyl bromide, while the other (control) group received 1 ml of normal saline (placebo).

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older
  • Term pregnancy
  • In spontaneous, established labour

Exclusion Criteria:

  • Contraindication to vaginal delivery
  • Any chronic medical or pregnancy induced illness
  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): NCT00409890


Locations
Jamaica
University of the West Indies
Kingston, Kingston 7, Jamaica
Sponsors and Collaborators
University Hospital of the West Indies
Investigators
Principal Investigator: Leslie A Samuels, MD University Hospital of the West Indies
  More Information

ClinicalTrials.gov Identifier: NCT00409890     History of Changes
Other Study ID Numbers: ECP 109,2004/2005
First Submitted: December 11, 2006
First Posted: December 12, 2006
Last Update Posted: December 12, 2006
Last Verified: December 2006

Keywords provided by University Hospital of the West Indies:
Buscopan
Hyoscine
Shortens
Labor
Stage

Additional relevant MeSH terms:
Bromides
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Anticonvulsants
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics