Outcomes After the Implementation of a New Oxytocin Protocol

What Was Tested

The trial (not phased) is built around Oxytocin.

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.

It had two arms (groups): Oxytocin (experimental) and Standard Practice (active comparator).

Oxytocin administered according to proposed protocol.

Oxytocin administered according to standard practice at facility.

The registry classes the interventions as drug.

More on the Plan

The proposed study is a prospective, randomized, active control, open label between subjects design.

One hundred sixty subjects will be randomly assigned to one of two groups (n = 80 per group): the oxytocin protocol group or the standard practice group.

The following is a summary of the procedures used in this study: 1.

All patients scheduled for an elective cesarean section will be prescreened by the investigator that is assigned as the student registered nurse anesthetist (SRNA) for that case.

Who Took Part

Enrollment: 64 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Over 18 years of age. Undergoing an elective cesarean section under neuraxial anesthesia.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: maternal or obstetrician refusal; multiple gestation; ruptured membranes.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-04 with completion listed for 2017-02-28.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in uterine tone. Time to adequate uterine tone (time frame: From the delivery of the infant to the completion of the cesarean section). Total calculated blood loss (time frame: 24 hours pre-op to 24 hours post-op).

It also tracked 3 secondary outcomes, for example Total estimated blood loss, Additional uterotonic drugs (in addition to oxytocin) required to establish adequate uterine tone: yes/no and Oxytocin side effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.