Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

Phase 3

• Conditions: Cesarean Section During Labor
• Interventions: Drug: Oxytocin

• Registration Number: NCT02794779
• Lead Sponsor: Brasilia University Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-04
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-09
• Study Start: 2016-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Cesarean delivery during labor.
• Spinal anesthesia

Exclusion Criteria

• Change of anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rule of three	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.
Continuous infusion	Oxytocin	Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.

Primary Outcome Measures

Name	Time	Method
Oxytocin dose	10 minutes	Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.

Trial Locations

Locations (1)

Hospital Universitário de Brasília; 🇧🇷 Brasilia, Distrito Federal, Brazil