The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.
| Condition | Intervention | Phase |
|---|---|---|
|
Labor Stage, First |
Drug: Hyoscine Butyl Bromide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies |
- 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.
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | October 2005 |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| Jamaica | |
| University of the West Indies | |
| Kingston, Kingston 7, Jamaica | |
| Principal Investigator: | Leslie A Samuels, MD | University Hospital of the West Indies |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00409890 History of Changes |
| Other Study ID Numbers: | ECP 109,2004/2005 |
| Study First Received: | December 11, 2006 |
| Last Updated: | December 11, 2006 |
| Health Authority: | Jamaica: Ministry of Health |
Keywords provided by University Hospital of the West Indies:
|
Buscopan Hyoscine Shortens Labor Stage |
Additional relevant MeSH terms:
|
Bromides Scopolamine Butylscopolammonium Bromide Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Mydriatics Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on May 22, 2013