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

Labor Stage, First Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409890
• Other study ID #: ECP 109,2004/2005
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2006
• Last updated: December 11, 2006
• Start date: June 2005
• Est. completion date: October 2005

Study information

• Verified date: December 2006
• Source: University Hospital of the West Indies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Stage, First

Intervention

Drug:
• Hyoscine Butyl Bromide

Locations

Country	Name	City	State
Jamaica	University of the West Indies	Kingston	Kingston 7

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of the West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.