Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial (MODCL)

Brasilia University Hospital

Status and phase

Unknown

Phase 3

Conditions

Cesarean Section During Labor

Treatments

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT02794779

anestesiatccthiago1416

Details and patient eligibility

About

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).

Enrollment

64 estimated patients

Sex

Female

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cesarean delivery during labor.
Spinal anesthesia

Exclusion criteria

Change of anesthesia

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Rule of three

Experimental group

Description:

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.

Treatment:

Drug: Oxytocin

Continuous infusion

Active Comparator group

Description:

Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.

Treatment:

Drug: Oxytocin