Hyoscine Butyl Bromide for Management of Prolonged Labor
Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial
1 other identifier
interventional
500
1 country
1
Brief Summary
To determine the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
Typical duration for phase_3
1 active site
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
First Submitted
Initial submission to the registry
May 11, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 10, 2017
March 1, 2017
3.2 years
May 11, 2013
March 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Caesarean section rate for failure to progress
6 hours
Study Arms (2)
Group A
ACTIVE COMPARATORGroup A, will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after.
Group B
PLACEBO COMPARATORGroup B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after.
Interventions
Eligibility Criteria
You may qualify if:
- Nulliparous women.
- Prolonged labor defined as no progress of labor for 2 hours or more.
- Gestational age ≥ 37 weeks.
- Singleton pregnancy.
- Cephalic presentation.
- Cervical dilatation ≥ 5 cm.
- Intact fetal membranes.
- No evidence of maternal or fetal distress.
- Average size baby.
You may not qualify if:
- Multigravid women.
- Multifetal pregnancy.
- History of cervical surgery.
- Blood pressure \> 150/90 mmHg.
- Mal-presentation and mal-positions.
- Hypersensitivity to Hyoscine.
- Contraindication for vaginal delivery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Labor and delivery ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, 'Asir Region, 101, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Ellaithy, MD
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of Obstetrics & Gynecology
Study Record Dates
First Submitted
May 11, 2013
First Posted
May 15, 2013
Study Start
February 1, 2014
Primary Completion
April 1, 2017
Study Completion
June 1, 2017
Last Updated
March 10, 2017
Record last verified: 2017-03