Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section
Condition: Bleeding; Anemia
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators compare the effectiveness and adverse effects of I.V carbetocin versus
      oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean
      section.
    

Detailed description: 
      -  Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths
           worldwide 1 and was the second most frequent cause of maternal death in the UK for the
           2000-2002 triennium.

        -  Caesarean section is a recognized risk factor for PPH and the worldwide caesarean
           delivery rate is increasing .2

        -  A combination of oxytocin and ergometrine is effective in preventing postpartum
           hemorrhage but is frequently associated with side effects such as retained placenta and
           hypertension.

        -  A recent guideline on PPH prevention developed by the World Health Organization
           recommended the use of oxytocin for prevention of PPH in settings in which active
           management of labor is not practiced.

        -  Ergometrine is an ergot alkaloid and hypertension and cardiac disease are
           contraindications due to the possible development of severe hypertension and myocardial
           ischemia.

        -  Carbetocin is a newly developed uterotonics and it may represent a promising choice as
           reported in the literature. It is a synthetic analogue of human oxytocin with structural
           modifications that increase its half-life thereby prolonging its pharmacological effects
           .

        -  A prospective double blinded randomized study . The study population will include 200
           patients. The study will take place in Beni_suef University Hospitals.

        -  Inclusion criteria:

           • Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks
           of gestation.

        -  Exclusion criteria

             -  Women undergoing cesarean section with general anesthesia will be excluded, because
                carbetocin is licensed for use with regional anaesthesia only.

             -  women undergoing cesarean section at less than 37 weeks of gestation (likely to be
                emergency cesarean sections; a different smaller group from term pregnancies)

             -  Hypertension with pregnancy.

             -  Cardiac and coronary diseases with pregnancy

        -  Women included in the study were divided into 2 groups:

      .Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of
      the fetal head.

      .Group (B): including 100 patients who will receive a combination of intraoperative oxytocin
      5 I.U & ergometrine 0.2 mg.
    

Intervention name(s): Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head; Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv
Intervention type(s): Drug; Drug
Intervention description(s): In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.; In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv
Other intervention name(s): Carbetocin; Oxytocin and Methyl ergometrine
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum hemorrhage, Cesarean section, Uterotonics