Carbetocin at Elective Cesarean Delivery
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 commonly 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.

      We hypothesize that a dose-response study will establish the minimum dose of carbetocin
      required to produce appropriate contractility in 95% of the women (ED95) 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. However, a dose response
      study to determine the minimum effective dose of carbetocin has not yet been published.

      Studies thus far show that carbetocin may be just as effective as oxytocin in promoting
      uterine contraction, with a similar side effects profile. In addition, patients receiving
      carbetocin may experience less blood loss, and require less additional uterotonics when
      compared with oxytocin.

      The results of this 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): 80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 90mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 110mcg carbetocin, IV, over 1 minute following delivery of the fetal head.; 120mcg 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