The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section

What Was Tested

The trial (not phased) is built around Oxytocin.

In this study, the investigators aim to investigate if artificial uterine contractions prior to elective caesarean section delivery may have an impact on the respiratory morbidity of term neonates.

It had two arms (groups): artificial contractions (ARTCON) group (experimental) and standard approach (SA) group (placebo comparator).

All participating patients in the control (SA) group will undergo placebo exposure in the form of a continuous intravenous infusion. The exposure will take two hours to complete and should be finished at least one hour before elective caesarean section is performed.

The registry classes the interventions as drug and other.

More on the Plan

In obstetrics, there is a well described and standardized way to induce artificial uterine contractions in order to predict fetal wellbeing and tolerance of labor, without inducing the labor itself.

This is the oxytocin challenge test (OCT).

Hence evaluation of the role of artificial uterine contractions in perinatal respiratory morbidity of term infants delivered by elective caesarean section is possible and of interest.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only.

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

Examples of who could join: Term/near-term pregnancy (36+0 - 41+6 weeks of gestation). Planned delivery by elective caesarean section. Absence of any.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: informed consent obtained; term premature rupture of membranes (tprom); spontaneous onset of uterine contractions.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2024-01-30 with completion listed for 2025-09-30.

It ran at 1 site in Czechia.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of neonatal respiratory morbidity (time frame: First 24 hours after delivery).

It also tracked 11 secondary outcomes, for example Oxytocin challenge test effectivity, Oxytocin challenge test safety and feasibility, Maternal blood loss, Total duration of surgery, Lamellar body count in amniotic fluid and Incidence of transitory tachypnoea of the newborn.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 200 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.