Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
NCT ID: NCT02794779
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
64 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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
Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Spinal anesthesia
Exclusion Criteria
18 Years
130 Years
FEMALE
No
Sponsors
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Brasilia University Hospital
OTHER
Responsible Party
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Gabriel Magalhaes Nunes Guimaraes
MD, MSc
Locations
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Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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anestesiatccthiago1416
Identifier Type: -
Identifier Source: org_study_id
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