Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)

What Was Tested

The trial (not phased) is built around Oxytocin.

The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.

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

Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden.

The most common indication of CD is labor dystocia.

However, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated.

The "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014.

Who Took Part

The registry lists 206 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

How the Study Was Run

Design: randomized, parallel-group and single-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.

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2022-08-01 with completion listed for 2023-07-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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: Duration of labor (maximum 24 hours from onset of labor)).

It also tracked 9 secondary outcomes, for example Intrapartum maternal birth injuries, Primary postpartum hemorrhage, Maternal fever/postpartum infections, Intrapartum fetal distress, Birth injuries of the newborn and Neonatal distress "asphyxia".

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 206 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.