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Sponsored by: |
University Hospital of the West Indies |
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Information provided by: | University Hospital of the West Indies |
ClinicalTrials.gov Identifier: | NCT00409890 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Jamaica, Kingston 7 | |
University of the West Indies | |
Kingston, Kingston 7, Jamaica |
Principal Investigator: | Leslie A Samuels, MD | University Hospital of the West Indies |
Study ID Numbers: | ECP 109,2004/2005 |
Study First Received: | December 11, 2006 |
Last Updated: | December 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00409890 History of Changes |
Health Authority: | Jamaica: Ministry of Health |
Buscopan Hyoscine Shortens Labor Stage |
Muscarinic Antagonists Neurotransmitter Agents Mydriatics Scopolamine Cholinergic Antagonists Bromides |
Adjuvants, Immunologic Anesthetics Butylscopolammonium Bromide Peripheral Nervous System Agents Cholinergic Agents Anticonvulsants |
Parasympatholytics Neurotransmitter Agents Scopolamine Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Butylscopolammonium Bromide Cholinergic Agents Pharmacologic Actions |
Adjuvants, Anesthesia Muscarinic Antagonists Mydriatics Bromides Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |