Outcomes After the Implementation of a New Oxytocin Protocol
Status:
Completed
Trial end date:
2017-02-28
Target enrollment:
Participant gender:
Summary
The proposed study is a prospective, randomized, active control, open label study. One
hundred sixty subjects undergoing elective cesarean section will be randomly assigned to one
of two groups (n = 80 per group): the oxytocin protocol group or the standard practice group.
The oxytocin protocol group will receive oxytocin boluses along with a regulated infusion
according to a stepwise algorithm following delivery of the placenta. The standard practice
group will receive oxytocin via a free flowing ("wide-open") infusion with a concentration of
30 IU per 500 mL of 0.9% normal saline following the delivery of the placenta. Primary
outcomes include uterine tone (adequate or inadequate) as assessed by the surgeon, amount of
time required to establish adequate uterine tone following the delivery of the infant, total
dose of oxytocin required to establish adequate uterine tone, and total calculated blood loss
based on pre-operative and post-operative hematocrit concentrations. Secondary outcomes
include total estimated blood loss as agreed upon by the surgeon and the anesthesia provider,
use of additional uterotonic drugs, mean arterial pressure, and incidence of oxytocin side
effects (nausea, chest tightness/pain, and ST-segment changes).