drugset / Trial / NCT03303235

Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections

NCT03303235

Phase 0 Withdrawn Johns Hopkins University
RandomizedParallel-groupTriple-blindTreatment

Summary

Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin. Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.

Timeline

Start
2020-07
Primary completion
2020-10
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylergonovine Small molecule 200 ug Intravenous

Indications