Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients
Condition: Uterine Atony With Hemorrhage
MeSH terms: Uterine Inertia; Hemorrhage
Intervention: Methylergonovine; Normal Saline (placebo)
Intervention description: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.; 1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
Intervention MeSH terms: Methylergonovine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methergine; Uterine Atony

Summary:

      Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality worldwide,
      even in high income countries. Uterine atony is estimated to cause 70-80% of postpartum
      hemorrhage. Prolonged labor and augmented labor are known risk factors for postpartum
      hemorrhage. In attempts to reduce the incidence of postpartum hemorrhage, particularly in
      patients with known risks factors, it is essential to optimize preventative practices in
      order to reduce the rates postpartum hemorrhage.

      Although oxytocin is considered the first line therapy for preventing and treating uterine
      atony, early consideration of additional prophylactic uterotonic agents may be indicated in
      women with prior oxytocin exposure given oxytocin receptor desensitization and down
      regulation.

      As such, investigators sought to examine whether multimodal prophylactic uterotonics
      (standard oxytocin + methylergonovine), in patients who are increased risk of developing
      postpartum hemorrhage (specifically laboring patients who ultimately require a cesarean
      section) would benefit from the addition of prophylactic uterotonics. The clinical rational
      for administration of multimodal prophylactic uterotonics at the time of cesarean delivery in
      laboring patients is three-fold: to decrease the incidence of uterine atony, to decrease the
      incidence of postpartum hemorrhage, decrease the number of uterotonics required at the time
      of cesarean section.

      The primary outcome will be to evaluate the need for additional uterotonic agents
      (Methylergonovine, Carboprost, Misoprostol) at the time of delivery.

      Secondary outcomes will include the incidence of postpartum hemorrhage (quantitative blood
      loss >1 liter), surgical assessment of uterine tone four minutes following delivery of the
      placenta, preoperative and postoperative hemoglobin, the need for a blood transfusion,
      intensive care unit admission, uterine infection (endometritis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Laboring patients who undergo a cesarean section

        Exclusion Criteria:

          -  Placenta/Uterine Abnormalities

          -  Chronic Hypertension, Gestational Hypertension, Preeclampsia

          -  HIV/AIDS on protease inhibitors

          -  History of Coronary Artery Disease

          -  History of Hypersensitivity to Methylergonovine