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Phase 4 N=160 Randomized Quadruple-blind Prevention

Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients

Uterine Atony With Hemorrhage

Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol) — 80; 80 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Methylergonovine (Drug); Normal Saline (placebo) (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Cynthia Wong
Primary completion
Feb 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)
80; 80
SECONDARY
Quantitative Blood Loss
967; 1315
SECONDARY
The Difference Between the Preoperative and Postoperative (Postpartum Day 1) Hemoglobin Values
2.36; 2.91
SECONDARY
Number of Patients With Unsatisfactory Uterine Tone 4 Min Following Delivery as Assessed by the Obstetrician
64; 33
SECONDARY
The Number of Patients Who Required a Blood Transfusion During the Delivery Hospitalization
4; 18

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03904446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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