Carbetocin at Elective Cesarean Delivery Part 3
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the
      most common uterotonic drug used to prevent and treat PPH in North America, however, there
      are some limitations to its use. Oxytocin has a very short duration of action, which requires
      a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians
      and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of
      carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post
      partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts
      4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater
      efficacy rate. However, a dose response study to determine the minimum effective dose of
      carbetocin has not yet been published. The investigators hypothesize that the minimum
      effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective
      Cesarean delivery.
    

Detailed description: 
      The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg
      intravenous bolus dose of carbetocin following Cesarean delivery.

      Studies thus far show that carbetocin may be just as effective as oxytocin in promoting
      uterine contraction, with a similar side effect profile. In addition, patients receiving
      carbetocin may experience less blood loss, and require less additional uterotonics when
      compared with oxytocin. Two dose response studies conducted at our institution (by Cordovani
      et al, and Anandakrishnan et al) suggested no difference in efficacy of uterine contraction
      for doses of carbetocin between 20-120mcg. Hypotension was noted for all dose groups studied.

      This study will be conducted as a prospective, randomized, up-down sequential allocation
      trial. The success or fail of a patient in the study will determine the dose given to future
      patients. Dosage will be increased for patients following a failed case, and kept the same
      for patients following successful cases. Following a successful case, there is also a 1 in 9
      chance that the dose will be decreased for the next patient.

      The results of this follow-up study will define the minimum required dose of carbetocin for
      uterine contraction, thus minimizing unnecessary side effects, improving quality and safety
      of patient care. It may also contribute in establishing carbetocin as a substitute to
      oxytocin for elective cesarean section at our institution as well as others.
    

Intervention name(s): Carbetocin
Intervention type(s): Drug
Intervention description(s): Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other intervention name(s): Duratocin
Intervention MeSH terms: Carbetocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin