Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
Condition: Postpartum Hemorrhage; Twin
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum
      hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are
      used to improve the muscle tone of the uterus after birth, and these are effective at
      reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada
      (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery
      to promote uterine contraction. In a study performed at Mount Sinai Hospital, the
      investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in
      achieving adequate uterine tone at elective cesarean section.

      In these dose-finding studies, women with multiple pregnancies have been excluded. Because
      women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy,
      prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is
      required. This question remains unanswered.

      The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing
      elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100
      mcg.
    

Detailed description: 
      There is a lack of consensus as to what the optimal uterotonic regime is globally.
      Furthermore, variability in the international guidelines regarding the choice of first line
      uterotonic in prevention of PPH adds to the confusion. With the widespread availability of
      carbetocin in some developed countries, including Canada, the question of which uterotonic to
      adopt and at which dose becomes even more difficult to ascertain. Studies that have currently
      been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine
      contraction with possibly fewer side effects associated with the lower dose regimens. There
      is evidence to suggest that lower doses of both carbetocin provide equivalent uterine
      contractions with a better side effect profile in patients with a singleton pregnancy.
      However, there is no clinical dosing data specifically for patients with twin pregnancy. The
      results of our study will provide guidance to obstetric and anesthetic providers worldwide
      when deciding what dose of carbetocin to use in women with twin pregnancy.
    

Intervention name(s): Carbetocin
Intervention type(s): Drug
Intervention description(s): Carbetocin administered intravenously, over 1 minute following delivery of the fetal head.
Other intervention name(s): Duratocin
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Biased coin up-and-down design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Twins; Postpartum hemorrhage; carbetocin; uterotonic; cesarean delivery