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Outcomes After the Implementation of a New Oxytocin Protocol

NCT02722356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-03-10

No results posted yet for this study

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).

Conditions

  • Complications; Cesarean Section
  • Adverse Reaction to Oxytocin

Interventions

DRUG

Oxytocin

Oxytocin administered per oxytocin group or standard practice group (see above)

Sponsors & Collaborators

  • C.R.Darnall Army Medical Center

    lead FED

Principal Investigators

  • John Murphy, DNP · Carl R. Darnall Army Medical Center, U.S. Army Graduate Program in Anesthesia Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722356 on ClinicalTrials.gov