Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Phase 4CompletedNCT02044549

Cairo University300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

300

Conditions

Postpartum Hemorrhage Blood Loss

Interventions

carbetocinDRUG

Oxycontin analogue

SyntometrineDRUG

Uterotonins

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ahmed Maged

Cairo, Egypt

Outcomes

Primary Outcomes

prevention of post partum hemorrhage after CS

Number of participants experienced postpartum hemorrhage

Time frame: 24 hours

Secondary Outcomes

side effects of drugs used

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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