Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean
1 other identifier
interventional
1,200
1 country
1
Brief Summary
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2018
Shorter than P25 for phase_4
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
September 27, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJanuary 3, 2020
January 1, 2020
12 months
September 27, 2018
January 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of postpartum hemorrhage after CS
Number of participants experienced massive postpartum hemorrhage
24 hours
Secondary Outcomes (1)
side effects of drugs used
24 hours
Study Arms (2)
carbetocin
EXPERIMENTAL600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Syntometrine
ACTIVE COMPARATOR600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
Interventions
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
Eligibility Criteria
You may qualify if:
- All participants are at 37 - 40 weeks of gestational age
- Noncomplicated pregnancy.
- obese women with BMI \> 30.
You may not qualify if:
- Participants with placenta previa,
- coagulopathy,
- preeclamptic
- known sensitivity to carbetocin,oxytocin or methergine were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
faculty of medicine Cairo university
Giza, 11231, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AHMED SAMY, MD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer in obstetrics and gynecology
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 3, 2018
Study Start
October 1, 2018
Primary Completion
September 15, 2019
Study Completion
September 30, 2019
Last Updated
January 3, 2020
Record last verified: 2020-01