Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

What Was Tested

The trial (not phased) is built around Oxytocin.

Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Elective uncomplicated cesarean delivery under neuraxial anesthesia. \>18 year-old with ASA status II or III, with a singleton gestation and a gestational age between 37 to 42 weeks Informed consent to participate in this study.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to oxytocin; body mass index ≥ 40 kg/m2on the day of admission.

How the Study Was Run

Design: non-randomized, parallel-group and quadruple-blind.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-07-26 with completion listed for 2022-04-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine tone upon discharge from the post anesthetic care unit (PACU): questionnaire (time frame: 2 hours).

It also tracked 20 secondary outcomes, for example Calculated blood loss, Incidence of post partum hemorrhage, Need for blood transfusion, Episodes of bleeding postpartum, Intraoperative requirement for additional uterotonic medication and Requirement for additional uterotonic medication in the PACU.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 40 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.