Cesarean Section During Labor
Conditions
Keywords
cesarean section, labor, oxytocin
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).
Interventions
DRUGOxytocin
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.
Sponsors
Brasilia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Cesarean delivery during labor. * Spinal anesthesia
Exclusion criteria
* Change of anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxytocin dose | 10 minutes | Minumum oxytocin dose for preventing uterine atony in 90% of cesareans. |
Countries
Brazil
Contacts
Primary ContactGabriel MN Guimaraes, MD, MSc
Backup ContactHelga BG Silva, MD, PhD
Outcome results
None listed