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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rule of three | Experimental | 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 | Active Comparator | Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin dose | Minumum oxytocin dose for preventing uterine atony in 90% of cesareans. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel MN Guimaraes, MD, MSc | Contact | +5561996455997 | gabrielmng@gmail.com | |
| Helga BG Silva, MD, PhD | Contact | 5561991755997 | helgabgs@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário de Brasília | Recruiting | Brasília | Federal District | 70000000 | Brazil |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |