Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409890
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Brief Title:
The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
Sponsor:
University Hospital of the West Indies
Organization:
University Hospital of the West Indies
Study Overview
Official Title:
The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mg1 mlof hyoscine butyl bromide while the other control group received 1 ml of normal saline placebo
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 mg1 mlof hyoscine butyl bromide while the other control group received 1 ml of normal saline placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None