NCT02794779

Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Brasilia University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cesarean Section During Labor

Interventions

Type	Name	Description
DRUG	Oxytocin	Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-06-09
• Last updated: 2017-01-31

Locations

1 site across 1 country: Brazil