Does Induction Dosage in Latent Phase Affect Active Phase of Labor?

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Oxytocin treatment in active phase of labour is used with respect to clinicians preference and best approach has not been described.

The researchers want to investigate the effect of oxytocin treatment by using different regims in latent phase of labor when oxytocin treatment is ceased in active phase of labour.

In their trial the researchers discontinued oxytocin in active phase of labour and investigate which group needs oxytocin therapy due to inadequate uterine contractions and arrest of labor.

Who Took Part

The registry lists 300 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.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

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 2018-12-15 with completion listed for 2019-06-15.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: need for oxytocin retreatment (time frame: an average of one year).

It also tracked 4 secondary outcomes, for example length of active phase, ratio of caesarean section and APGAR scores.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 300 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.