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

Phase 2

Completed

• Conditions: Labor Stage, First

• Registration Number: NCT00409890
• Lead Sponsor: University Hospital of the West Indies

Brief Summary

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

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).

Study Timeline

• Study Start: 2005-06
• Study Completion: 2005-10
• Status Verified: 2006-12
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Last Update Submitted: 2006-12-11
• Study First Posted: 2006-12-12
• Last Update Posted: 2006-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of the West Indies; 🇯🇲 Kingston, Kingston 7, Jamaica