NCT00409890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
Last Updated

December 12, 2006

Status Verified

December 1, 2006

First QC Date

December 11, 2006

Last Update Submit

December 11, 2006

Conditions

Labor Stage, First

Keywords

BuscopanHyoscineShortensLaborStage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

Hyoscine Butyl BromideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the West Indies

Kingston, Kingston 7, Jamaica

Location

Study Officials

  • Leslie A Samuels, MD

    University Hospital of the West Indies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

June 1, 2005

Study Completion

October 1, 2005

Last Updated

December 12, 2006

Record last verified: 2006-12

Locations

JA(1)