Labor Scale Versus WHO Partograph in the Management of Labor

What Was Tested

The trial (not phased) is built around Oxytocin.

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes.

It had two arms (groups): Labor scale (experimental) and WHO partograph (active comparator).

Observation Amniotomy Oxytocin Cesarean Section (CS).

Observation Amniotomy Oxytocin Cesarean Section (CS).

The registry classes the interventions as drug and procedure.

More on the Plan

Of these indications, the most reported one was labour dystocia.

The WHO partograph is a famous chart that is commonly used to observe uncomplicated labour and is almost an objective approach to guide interference.

Furthermore, the design of the partograph is not exactly perfect to present the process of labour.

For these reasons, the labour scale was designed as a novel follow-up chart during labour.

Who Took Part

120 planned participants were the target.

It was open to women only aged from 18 years up to 35 years.

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

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: maternal medical or surgical major co-morbidity; previous uterine scar; induction of labor.

How the Study Was Run

The set-up was 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 2015-07 with completion listed for 2016-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) (time frame: Time of labor (maximum 24 hours)).

It also tracked 7 secondary outcomes, for example Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration), Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions, Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture, Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring and birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management ).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 120 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.