Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Phase 4

Completed

• Conditions: Postpartum Hemorrhage; Blood Loss
• Interventions: Drug: Syntometrine; Drug: carbetocin

• Registration Number: NCT02044549
• 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 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 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: 2014-01-15
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• All participants are at 37 - 40 weeks of gestational age
• Noncomplicated pregnancy.

Exclusion Criteria

• Participants with placenta previa
• Patients with coagulopathy
• preeclamptic women
• known sensitivity to oxytocin or methergine were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Syntometrine	Syntometrine	Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
carbetocin	carbetocin	single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.

Primary Outcome Measures

Name	Time	Method
prevention of post partum hemorrhage after CS	24 hours	Number of participants experienced postpartum hemorrhage

Secondary Outcome Measures

Name	Time	Method
side effects of drugs used	24 hours	Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Trial Locations

Locations (1)

Ahmed Maged; 🇪🇬 Cairo, Egypt