Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Rule of three
    • 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.
  • Active Comparator: Continuous infusion
    • Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.

Clinical Trial Outcome Measures

Primary Measures

  • Oxytocin dose
    • Time Frame: 10 minutes
    • Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.

Participating in This Clinical Trial

Inclusion Criteria

  • Cesarean delivery during labor.
  • Spinal anesthesia

Exclusion Criteria

  • Change of anesthesia

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 130 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brasilia University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gabriel Magalhaes Nunes Guimaraes, MD, MSc – Brasilia University Hospital
  • Overall Contact(s)
    • Gabriel MN Guimaraes, MD, MSc, +5561996455997, gabrielmng@gmail.com

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