Carbetocin at Elective Cesarean Delivery Part 2
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 to determine the minimum effective dose of carbetocin
      has not yet been published. The investigators hypothesize that the minimum effective dose
      (ED90) is above 20mcgs and below 80mcgs 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. A dose response study conducted by Cordovani et al suggested no
      difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg.
      Additionally, hypotension was noted for all dose groups studied.

      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; Carbetocin; Carbetocin; Carbetocin; Carbetocin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other intervention name(s): Duratocin; Duratocin; Duratocin; Duratocin; Duratocin
Intervention MeSH terms: Carbetocin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin