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

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Methylergonovine

Criteria

Inclusion Criteria:

• All patients admitted for elective cesarean section

• All laboring patients for planned vaginal delivery as these women may have an unplanned cesarean delivery for maternal or for fetal indications

• Patients not in labor but admitted for non-elective cesarean section

• Administration of oxytocin prior to administration of methylergonovine, in accordance to the ACOG guideline for postpartum hemorrhage

• Obstetrician's request for methylergonovine intraoperatively to the anesthesiologist

Exclusion Criteria:

• Fetus not considered to be of viable gestational age by obstetrical team

• Patients with hypertension (either chronic or pregnancy-induced, including preeclampsia)

• Patients with coronary artery disease, established and diagnosed by medical internist or cardiologist

• Patients taking CYP3A4 inhibitors

• Patients taking beta blockers.

• Patients with contraindications to any of the uterotonic agents for whatever medical reason (allergies, for example)

• Surgeon request for administration of methylergonovine earlier than per protocol due to clinical situation as abovementioned

• Maternal or obstetrician refusal

• Patients who require obstetrical intervention before 30 minutes has elapsed