Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Phase 4

Completed

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: Syntometrine; Drug: carbetocin

• Registration Number: NCT03693599
• Lead Sponsor: Cairo University

Brief 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

Study Timeline

• Study First Submitted: 2018-09-27
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-01
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• All participants are at 37 - 40 weeks of gestational age
• Noncomplicated pregnancy.
• obese women with BMI > 30.

Exclusion Criteria

• Participants with placenta previa,
• coagulopathy,
• preeclamptic
• known sensitivity to carbetocin,oxytocin or methergine were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Syntometrine	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
carbetocin	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).

Primary Outcome Measures

Name	Time	Method
incidence of postpartum hemorrhage after CS	24 hours	Number of participants experienced massive postpartum hemorrhage

Secondary Outcome Measures

Name	Time	Method
side effects of drugs used	24 hours	GIT side effects as nausea , vomiting

Trial Locations

Locations (1)

faculty of medicine Cairo university; 🇪🇬 Giza, Egypt