Carbetocin at Cesarean Delivery for Labor Arrest
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national
      clinical guidelines on important women's health issues, recommended that a bolus of
      carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of
      oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to
      oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the
      recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be
      used to achieve the same degree of uterine contractility with less side effects. So far, the
      ideal dose to be used in cesarean sections for labouring women who have failure to progress
      in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not
      descending the birth canal) has not been determined. This study is designed to determine the
      minimum carbetocin dose required during cesarean delivery for 'failure to progress' to
      achieve the best effect.
    

Detailed description: 
      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.

      The evidence reported for Carbetocin use in the literature has mostly been based upon low
      risk non-laboring patients undergoing elective cesarean deliveries. At present, only 2
      studies have looked at the use of Carbetocin in low risk patients requiring emergency
      cesarean deliveries. The minimum effective dose (ED90) of carbetocin in laboring women has
      not been determined so far. Similar to oxytocin, the ED90 of Carbetocin is likely to be
      higher in laboring women undergoing Cesarean deliveries as compared to the non-laboring
      women, due to the effect of the desensitization phenomenon.

      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 study will establish the minimum effective dose of carbetocin for uterine
      contraction at cesarean delivery for labor arrest. This will likely minimize unnecessary side
      effects caused by a large bolus dose of the drug, and improve quality and safety of patient
      care.
    

Intervention name(s): Carbetocin
Intervention type(s): Drug
Intervention description(s): Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
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; failure to progress in labor