Oxytocin in Cesarean Delivery

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone.

In order to perform this study the investigators perform the following steps: 1.

The investigators validate a quantitative measure of uterine tone as their primary endpoint. 2.

It had two arms (groups): Oxytocin (active comparator) and Oxytocin - ergometrine (experimental).

The registry classes the interventions as drug.

More on the Plan

However, the use of these drugs is not without side effects and complications.

In this study the researchers hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone.

Who Took Part

80 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 80 healthy women presenting for elective repeat cesarean delivery under regional anesthesia. All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2010-11 with completion listed for 2011-05.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine tone (time frame: Up to 30 minutes).

It also tracked 2 secondary outcomes, for example Plasma levels of oxytocin and Subjective side effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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