drugset / Trial / NCT02794779

Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

NCT02794779

Phase 3 Unknown 64 enrolled Brasilia University Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women. Objective: to determine the minimum effective dose of oxytocin for cesareans during labor. Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).

Timeline

Start
2016-07
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 0.4 iu Intravenous
Subject Oxytocin Peptide 3 iu Intravenous

Indications

No indication recorded.