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Trials / Completed

CompletedNCT00409890

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
120 (planned)
Sponsor
University Hospital of the West Indies · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGHyoscine Butyl Bromide

Timeline

Start date
2005-06-01
Completion
2005-10-01
First posted
2006-12-12
Last updated
2006-12-12

Locations

1 site across 1 country: Jamaica

Source: ClinicalTrials.gov record NCT00409890. Inclusion in this directory is not an endorsement.

The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies (NCT00409890) · Clinical Trials Directory