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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409890
Enrollment
120
Registered
2006-12-12
Start date
2005-06-30
Completion date
2005-10-31
Last updated
2006-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Stage, First

Keywords

Buscopan, Hyoscine, Shortens, Labor, Stage

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).

Interventions

Sponsors

University Hospital of the West Indies
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Jamaica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026