Accelerated Titration of Oxytocin for Nulliparous Patients With Labour Dystocia: ACTION Pilot Study

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

The aims of this pilot feasibility are: 1.

To assess the feasibility of a large multi-centre randomized control trial comparing the two above oxytocin protocols (accelerated titration versus gradual titration for correction of dystocia). 2.

It had two arms (groups): Accelerated Oxytocin Titration (experimental) and Gradual Oxytocin Titration (active comparator).

The registry classes the interventions as drug.

More on the Plan

Almost half of all primary caesarean sections are performed for labour dystocia - when labour is abnormally slow or when there is no further progression in cervical dilatation.

There is a wide range of oxytocin regimens currently in use.

These protocols differ mainly in the rate at which the desired physiologic response is achieved.

Who Took Part

79 actual participants took part.

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: Capability of participant to comprehend English and/or French and to comply with study requirements. ≥ 18 years of age at time of consent. No contraindications to trial of labour or vaginal birth. Term pregnancy (37+0 to 42+0 weeks gestation). Spontaneous onset of labour.

The full record lists 17 inclusion and 14 exclusion criteria; among the exclusions: serious medical condition (severe cardiac, pulmonary, or renal disease); known fetal anomaly; known sensitivity to oxytocin.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

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 and investigator.

It started in 2012-04 with completion listed for 2013-10.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Consent Rate (time frame: From screening for eligibility until randomization (up to 5 weeks)). Protocol Violation Rate (time frame: From admission to a hospital for delivery until delivery (up to 1 week)). Maternal satisfaction (time frame: from hospital admission to 4 weeks postpartum).

It also tracked 2 secondary outcomes, for example Caesarean section rate and Rate of Maternal and Fetal/Neonatal Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 79 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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