Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
MODCL
1 other identifier
interventional
64
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 31, 2017
January 1, 2017
1.4 years
June 4, 2016
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxytocin dose
Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.
10 minutes
Study Arms (2)
Rule of three
EXPERIMENTALIntravenous 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
ACTIVE COMPARATORContinuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Cesarean delivery during labor.
- Spinal anesthesia
You may not qualify if:
- Change of anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário de Brasília
Brasília, Federal District, 70000000, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
June 4, 2016
First Posted
June 9, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 31, 2017
Record last verified: 2017-01