Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial
Condition: Delivery
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      250 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). Both drugs will be diluted in 10ml
      saline and will be given by the slowly intravenously after delivery of the anterior shoulder.
      The investigators will not include a control group for ethical reasons.
    

Detailed description: 
      Obstetric haemorrhage remains one of the major causes of maternal death in both developed and
      developing countries (1). 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 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 with at least 2 risk factors for developing atonic PPH will be approached in the
      antenatal clinic or early in labour if appropriate. Risk factors include previous PPH,
      BMI>35, multiple pregnancy, prolonged labour >12 hours, fetal macrosomia>4kg and induction of
      labour. Women 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.

      250 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). Both drugs will be diluted in 10ml
      saline and will be given by the slowly intravenously after delivery of the anterior shoulder.
      We will not include a control group for ethical reasons.

      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): Carbetocin will be given slowly iv after delivery of the anterior shoulder.; Oxytocin will be given slowly iv after delivery of the anterior shoulder.
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention