Outcomes After the Implementation of a New Oxytocin Protocol

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: C.R.Darnall Army Medical Center
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Pregnant women with American Society of Anesthesiologists (ASA) physical status II (subjects with ASA physical status III based solely on a body mass index [BMI] ≥ 40 will be included in the study)

• Over 18 years of age

• Undergoing an elective cesarean section under neuraxial anesthesia

Exclusion Criteria:

• Maternal or obstetrician refusal

• Multiple gestation

• Ruptured membranes

• Abnormal placentation

• Preexisting coagulopathy

• Macrosomia

• Chorioamnionitis

• Diabetes mellitus (preexisting, not gestational)

• Uterine fibroids

• Contraindication to neuraxial anesthesia

• Previous allergic reaction to synthetic oxytocin