Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Obesity, Morbid; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the
      most commonly used uterotonic drug for the active management of third stage labor, to reduce
      the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the
      SOGC (Society of Obstetricans & Gynecologists of Canada), and is a relatively newer drug with
      a longer duration of action. It has been previously demonstrated that women with elevated BMI
      require higher doses of these drugs to induce adequate uterine contraction and dose finding
      studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be
      carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use
      of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and
      requirement of additional uterotonic medications. No study has directly compared the two
      drugs in obese parturients in a head to head clinical trial; therefore a double-blind
      randomized controlled trial is necessary to show the non-inferiority of carbetocin against
      the current standard of care at Mount Sinai hospital, which is oxytocin.
    

Detailed description: 
      Obesity in pregnancy is defined as a Body Mass Index (BMI) above 30 kg/m2 and is often cited
      as a risk factor for PPH after cesarean delivery.

      The World Health organization (WHO) recommends that uterotonic medications are routinely
      administered at cesarean delivery for the active management of the third stage of labor, both
      to facilitate delivery of the placenta and to reduce the risk of PPH. The optimal regimen for
      active management of third stage of labor is yet to be fully determined and obesity adds
      another layer of complexity and risk, with higher doses required to induce adequate uterine
      contraction. While oxytocin is the most commonly used drug world-wide, multiple agents are
      available and there is no clear consensus as to which drug should be first choice. Multiple
      studies have shown that carbetocin is associated with reduced post-partum bleeding, need for
      blood transfusion and additional uterotonic medications, in the non-obese population.

      The results of this study will provide evidence on the non-inferiority of carbetocin when
      compared directly to the current standard of care at Mount Sinai hospital, which is oxytocin.

      The investigators hypothesize that when administered in equipotent doses, carbetocin would be
      non-inferior to oxytocin in women with BMI ≥40 kg/m2 undergoing elective cesarean delivery.

      The investigators hope to prove that the difference between uterine tone elicited by
      carbetocin falls within the inferiority margin of -1.2 using a verbal numerical rating score.
    

Intervention name(s): Carbetocin; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.; Patient is given oxytocin (1IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).
Other intervention name(s): Duratocin; Pitocin
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; postpartum hemorrhage; cesarean delivery; carbetocin; duratocin; oxytocin