Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
Condition: Obstetrics
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      200 women will be randomly divided into 2 equal groups using computer generated random
      numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will
      receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).
    

Detailed description: 
      Obstetric haemorrhage remains one of the major causes of maternal death in both developed and
      developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of
      blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor
      (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony,
      contributing up to 80 % of the PPH cases.

      Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body
      mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.

      Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence
      of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of
      oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous
      infusion or repeated intramuscular injections.

      Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony
      after child birth by cesarean section (CS) under epidural or spinal anaesthesia. Carbetocin
      has a rapid onset of action (within 1-2 min) and a prolonged duration of action
      (approximately 1 h) because of sustained uterine response with contractions of higher
      amplitude and frequency. Its safety profile is comparable to that of oxytocin The study will
      be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients
      attending the labour ward with low risk of developing PPH will be invited to participate in
      the study, the invitation will include a clear full explanation of the study. Only patients
      signing informed written consents will participate in the study.

      200 women with atonic PPH will be randomly divided into 2 equal groups using computer
      generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and
      group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). We will not include a
      control group for ethical reasons.

      Once atonic PPH is diagnosed, 2 14-gauge cannulas will be inserted and a crystalloid
      intravenous (iv) infusion will be started. The allocated drug will be diluted in 10ml saline
      and will be given slowly iv, the fundus will be rubbed, A Foley's catheter will be inserted
      and a fluid balance chart will be commenced, pulse and blood pressure will be recorded every
      15 minutes, venepuncture will be done for cross matching 4 units of blood, full blood count
      and coagulation screen.

      The uterine tone and amount of bleeding will be noted and the need for further uterotonic
      agents will be determined 2 minutes after giving the drug. Blood loss will be estimated
      through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24
      hours after delivery.
    

Intervention name(s): Carbetocin; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 100 women with atonic PPH will receive Carbetocin 100 µgm slowly iv.; 100 women with atonic PPH will receive Oxytocin 5IU slowly iv.
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment