The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia

What Was Tested

The trial (not phased) is built around Oxytocin.

The aim of this study is to determine the influence of oxytocin on fetal well-being during labor in patients receiving epidural analgesia (ELA) with the use of cardiotocography (CTG) and doppler ultrasonography.

CTG is a commonly used technique to monitor the fetal heartbeat and contractions of uterus during pregnancy and labor.

The maternal-fetal doppler ultrasonography is a non-invasive method used for the pregnancy surveillance.

It had two arms (groups): Oxytocin Group (experimental) and Control Group (placebo comparator).

The registry classes the interventions as other.

More on the Plan

The study will recruit 200 patients in either labor induced by oxytocin or stimulated with oxytocin at 37-42 weeks of gestation, requesting the epidural labor analgesia (ELA) and meeting the inclusion criteria.

After 2 hours the patients will be examined to assess the progress of labor.

If no progress is detected due to the secondary weakening of uterus contractile function, the oxytocin will be reintroduced in the control group.

Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Who Took Part

Enrollment: 200 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: ≥ 18 years old. Labor induced by oxytocin or stimulated with oxytocin. Signed informed consent form. Cervical dilation ≥ 3cm. Patient requesting and eligible for epidural analgesia.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: less than 18 years old; preterm delivery; multiple pregnancy.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-05-06 with completion listed for 2025-12-31.

It ran at 1 site in Poland.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Changes in CTG pattern (time frame: During the first two hours after the enrollment). Maternal-Fetal Doppler (time frame: From the enrollment to the first day after the delivery). Labour progression (time frame: The first two hours after the enrollment).

It also tracked 7 secondary outcomes, for example Duration of labor, Mode of the delivery, Umbilical cord blood gasometry, Apgar score, Birth weight of the newborn and Presence of Neonatal Complications.

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.