Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour.

It had two arms (groups): early umbilical cord occlusion (active comparator) and delayed umbilical cord occlusion (experimental).

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 150 planned participants were the target.

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: Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation. Patients must be over 18 years old. Patient understands and signs informed consent.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: urgent c-section; gestational age under 22 or over 33 weeks; major uterine malformations.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2014-07 with completion listed for 2017-07.

It ran at 1 site in Spain.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of red blood cell transfusions to the newborn (time frame: for the duration of hospital stay, an expected average of 2 months). Intraventricular Haemorrhage incidence (time frame: from delivery, for the duration of hospital stay, an expected average of 2 months). Maternal postpartum haemorrhage incidence (time frame: within 24 hours after birth).

It also tracked 1 secondary outcome, for example Neonatal mortality.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 150 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.