NCT03693599

Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Detailed description

A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 women) after fetal extraction and before placental removal. 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

• Post Partum Hemorrhage

Interventions

Type	Name	Description
DRUG	carbetocin	single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
DRUG	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

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-09-15
• Completion: 2019-09-30
• First posted: 2018-10-03
• Last updated: 2020-01-03

Locations

1 site across 1 country: Egypt