Status:
WITHDRAWN
Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
Lead Sponsor:
Johns Hopkins University
Conditions:
Uterine Atony
Uterine Tone Disorders
Eligibility:
FEMALE
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
The United States is one of the few modern countries in which maternal peripartum mortality continues to rise. One of the three most important causes of maternal mortality is severe hemorrhage. Contro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03303235
Start Date
July 1 2020
End Date
December 1 2020
Last Update
August 3 2020
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287