Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2013

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

Interventions

  • Drug: carbetocin
    • Oxycontin analogue
  • Drug: Syntometrine
    • Uterotonins

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • prevention of post partum hemorrhage after CS
    • Time Frame: 24 hours
    • Number of participants experienced postpartum hemorrhage

Secondary Measures

  • side effects of drugs used
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Maged, Assistant professor – Cairo University
  • Overall Official(s)
    • Ahmed Maged, MD, Principal Investigator, Ass prof kasr aini medical school

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