Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients

Status

Completed

Phase

Phase 4

Enrollment

160 participants (actual)

Sponsor

Cynthia Wong · Other

Design

Randomized · Quadruple masking

Countries

1 country

United States

Start

8 Jun 2019

Primary completion

15 Feb 2021

Completion

15 Feb 2021

First posted

5 Apr 2019

Last update posted

1 Aug 2022

Conditions

Uterine Atony With Hemorrhage

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).

• Experimental

  Methylergonovine 0.2 mg

  Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine

• Placebo comparator

  Placebo (Normal Saline)

  Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular

1. Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)

   Time frame · Assessed from the time of cesarean section until 24 hours postdelivery

   Registry description

   Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents the outcome measure will be yes or no.