Delayed Cord Clamping and Use of Oxytocin

What Was Tested

This registered phase 3 trial tested Oxytocin.

The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.

It had two arms (groups): oxytocin inmediately at birth (active comparator) and oxytocin at 3 minutes (experimental).

The registry classes the interventions as drug.

More on the Plan

Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.

Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.

The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.

In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.

Who Took Part

Enrollment: 180 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Healthy single Term pregnancies. Informed consent obtained. Presence of an investigator.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: placenta previa; previous history of postpartum hemorrhage; intrauterine growth restriction .

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2016-05 with completion listed for 2016-11.

It ran at 1 site in Argentina.

What Was Measured

The main thing measured (primary outcome): placental transfusion (time frame: between birth and 3 minutes of life).

It also tracked 3 secondary outcomes, for example bilirubin, Hematocrit and Maternal blood loss.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 180 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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