Outcomes After the Implementation of a New Oxytocin Protocol

NCT02722356 | Completed

• 1 other identifier: 417969-1
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in uterine tone

  Uterine tone deemed adequate or inadequate as assessed by the surgeon

  3, 6, and 9 minutes after first dose of oxytocin

• Time to adequate uterine tone

  Amount of time (minutes) required to establish adequate uterine tone following the delivery of the infant

  From the delivery of the infant to the completion of the cesarean section

• Oxytocin dose

  Total dose of oxytocin required to establish adequate uterine tone

  Duration of cesarean section

• Total calculated blood loss

  Total calculated blood loss based on pre-operative and post-operative hematocrit concentrations

  24 hours pre-op to 24 hours post-op

Secondary Outcomes (3)

• Total estimated blood loss

  Duration of cesarean section

• Additional uterotonic drugs (in addition to oxytocin) required to establish adequate uterine tone: yes/no

  Duration of cesarean section

• Oxytocin side effects

  Duration of cesarean section

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin administered according to proposed protocol

Drug: Oxytocin

Standard Practice

ACTIVE COMPARATOR

Oxytocin administered according to standard practice at facility

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: Pitocin

Oxytocin; Standard Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C.R.Darnall Army Medical Center: lead

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• John Murphy, DNP

  Carl R. Darnall Army Medical Center, U.S. Army Graduate Program in Anesthesia Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CPT, Student Registered Nurse Anesthetist

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 30, 2016
• Study Start: April 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03