Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women
Condition: Obesity, Maternal; Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Obesity, Maternal; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Postpartum hemorrhage [PPH] can have serious consequences and is the leading cause of
      maternal mortality globally. Uterine contractility plays an important role in post-delivery
      uterine involution; impaired contractility can contribute to PPH. Should contractility be
      impaired among obese women, there would be implications for management. Therefore, the
      investigators sought to investigate whether obese women would also experience a need for more
      uterine agents during the management of an obstetric hemorrhage.
    

Detailed description: 
      The American College of Obstetricians and Gynecologists (ACOG) updated their definition of
      postpartum hemorrhage (PPH) to be "blood loss greater than or equal to 1000 ml or blood loss
      accompanied by signs or symptoms of hypovolemia" .

      Recent clinical and translational studies have suggested a decrease in uterine contractility
      among obese and morbidly obese women as a primary cause of obstetric hemorrhage.

      In the United States, the prevalence of maternal obesity has been steadily rising, with more
      than half of pregnant women classified as overweight or obese. A panel of obstetric experts
      has speculated that the rising prevalence of maternal obesity in developed countries may
      explain the increase in postpartum hemorrhage incidence.

      Uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage
      (PPH) after Cesarean delivery.

      There are several prophylactic uterotonic agents available for use, including oxytocin,
      oxytocin/ergometrine, and carbetocin. Carbetocin is a synthetic analog of oxytocin which
      provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).

      The investigators aim to investigate the impact of carbetocin on uterine contractility in
      obese versus non-obese pregnant women undergoing elective cesarean delivery following
      carbetocin 100 mcg bolus IV administration as a prophylaxis of postpartum hemorrhage in a
      randomized controlled trial. The incestigators hypothesize that increased volume of
      distribution reduces the bioavailability of carbetocin and may be an explanation for reduced
      efficacy. Also the investigators will examine uterine tone as a surrogate marker for the
      bioavailability of carbetocin.
    

Intervention name(s): Carbetocin 100 Microgram/mL Solution for Injection
Intervention type(s): Drug
Intervention description(s): All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [PabalVR, Ferring AG, Baar, Switzerland]).then assess uterine contractility and postpartum bleeding measuring
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention