Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean
NCT ID: NCT03693599
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1200 participants
INTERVENTIONAL
2018-10-01
2019-09-30
Brief Summary
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Detailed Description
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Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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carbetocin
600 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).
carbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Syntometrine
600 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
Syntometrine
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
Interventions
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carbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Syntometrine
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
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Inclusion Criteria
* Noncomplicated pregnancy.
* obese women with BMI \> 30.
Exclusion Criteria
* coagulopathy,
* preeclamptic
* known sensitivity to carbetocin,oxytocin or methergine were excluded
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Principal Investigators
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AHMED SAMY, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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faculty of medicine Cairo university
Giza, , Egypt
Countries
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Other Identifiers
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carbetocin
Identifier Type: -
Identifier Source: org_study_id
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