NCT05341076

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

Labor Scale Versus WHO Partograph for Management of Spontaneous Labor in Primigravidae (ScaLP): A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Since the procedure was first introduced to clinical practice, Cesarean delivery (CD) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. Nevertheless, CD rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden. Over years, long-term sequelae of current CD rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in CD trend, since 90% of women who had CD are susceptible to CD in future pregnancies. These concerns have triggered a global act to control CD rates within the margins of safe obstetric practice. 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 WHO partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify CD decision However, a cochrane review by Lavender et al. revealed that role of WHO partograph, in improving clinical outcomes, is lacking. In addition, there is no evidence that any published modification of the current partograph is superior to another. The "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014. The tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. Initial data showed that labor scale contributed to decreased incidence of CD and oxytocin administration. However, further studies are required to verify these results.

Conditions

• Dystocia

Interventions

Type	Name	Description
PROCEDURE	Amniotomy	Amniotomy, artificial rupture of membranes, is done with an initial delay of labor (in partograph: extension beyond the alert line, in labor scale: when progress reaches the membrane line)
DRUG	Oxytocin	oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
PROCEDURE	Cesarean Section	Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

1 site across 1 country: Egypt