drugset / Trial / NCT01549223

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

NCT01549223

Phase 4 Completed 60 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will: 1\. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. Secondary outcomes to be evaluated will be: 1. Reduce the side effects associated with uterotonic drug use 2. Reduce the time to establishment and maintenance of adequate uterine tone

Timeline

Start
2011-04
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboprost Tromethamine Unknown 0.25 mg Intramuscular
Subject Methylergonovine Small molecule 0.2 mg Intramuscular
Subject Misoprostol Other / unclassified 600 ug Other
Comparator Oxytocin Peptide 3 iu Intravenous
Comparator Oxytocin Peptide 30 iu Intravenous