Newborn Pain and Stress Levels in Oxytocin Induction at Birth

What Was Tested

This registered not phased trial tested Oxytocin.

The aim of the study is to compare pain and stress levels in the early neonatal period in newborns with and without oxytocin induction.

The research was conducted in a case-control study design.

The population of the study consisted of participants who gave birth vaginally (with or without oxytocin induction).

It had two arms (groups): Oxytocin induction group (active comparator) and Control group (active comparator).

Participants in the oxytocin induction group received oxytocin induction during labour. The ALPS-Neo form was completed between 1-40 minutes after delivery, based on observation before, during and after the drying process, the first injection process and the blood glucose measurement procedures.

Participants in the control group did not receive oxytocin induction during labour. The ALPS-Neo form was completed between 1-40 minutes after delivery, based on observation before, during and after the drying process, the first injection procedure and the blood glucose measurement procedures.

The registry classes the interventions as behavioral.

More on the Plan

Purpose: To compare the pain and stress levels of painful stimuli in the early neonatal period in newborns with and without oxytocin induction.

H1: There is a statistical difference between the ALPS-Neo scores of the newborns of the group in which oxytocin induction was applied in labor and the group in which it was not applied.

H0: There is no statistical difference between the ALPS-Neo scores of the newborns of the group that underwent oxytocin induction in labor and the group that did not.

In the study, participants were divided into two groups: those with and without oxytocin induction, and the data were collected based on self-report.

Who Took Part

The registry lists 164 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pregnant at term,. Giving birth vaginally,. Birth weight ≥2500gr,. Participants with a single and healthy fetus and their newborns.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: mentally incompetent,; having a high-risk pregnancy,; those with risky newborns.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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 2023-01-20 with completion listed for 2023-12-10.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): Filling out the ALPS-Neo form before the newborn drying procedure (time frame: In the first minute after birth). Filling in the ALPS-Neo form during the newborn drying process (time frame: At 5 minutes after birth). Filling out the ALPS-Neo form after the newborn drying procedure (time frame: At the 5th minute after drying).

It also tracked 3 secondary outcomes, for example Completion of the ALPS-Neo form before the first injection procedure in the newborn, Completion of the ALPS-Neo form during the first injection procedure in the newborn and Completion of the ALPS-Neo form after the first injection procedure in the newborn.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 164 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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