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Oxytocin Administration Prior Planned Caesarean Section

Plain-language guide to NCT03693885: not phased randomized trial of Oxytocin, 1450 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03693885
Phase
not phased
Status
status unknown
Start
2019-01-01
Completion (planned or actual)
2024-12-31
Participants
1450 (estimated)
Design
randomized, open label (everyone knows who gets what), prevention
Conditions studied
Respiratory Insufficiency Syndrome of Newborn; Breastfeeding Status
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g.

AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation.

In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction.

It had two arms (groups): OCT-group (experimental) and Control (no intervention).

Standard procedure before planned caesarean section.

The registry classes the interventions as other.

Who Took Part

The registry lists 1450 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Singleton pregnancy \>34 weeks. Primary caesarean section, that is without preceding contractions or rupture of the membranes,. Absence of a contraindication to oxytocin.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: chromosomal aberration; nonreassuring fetal heart rate pattern,; placenta praevia,.

How the Study Was Run

Design: 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 2019-01-01 with completion listed for 2024-12-31.

It ran at 5 sites in Switzerland (5).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Incidence of neonatal respiratory morbidity (time frame: in the first 4 hours of life).

It also tracked 3 secondary outcomes, for example Umbilical cord blood copeptin levels, Postnatal neonatal weight change and Breastfeeding status.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 1450 people.

With 1450 participants it is a large trial for this field.

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.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.