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

A

Assiut University

Status

Unknown

Conditions

Dystocia

Treatments

Procedure: Amniotomy
Procedure: Cesarean Section
Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT05341076
MCOG1-22

Details and patient eligibility

About

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.

Full 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.

Enrollment

206 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Pregnant women aged 18 to 45 years old with the following criteria: nulliparous, had been pregnant for 37 to 41 weeks with a singleton viable fetus, and vertex presented, and with estimated fetal weights between 2,500 and 4,500 g.

Exclusion Criteria Women with following criteria will be excluded: significant maternal medical or surgical comorbidity, previous uterine scar

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

206 participants in 2 patient groups

Labor scale
Experimental group
Description:
Observation Amniotomy Oxytocin Cesarean Section (CS)
Treatment:
Drug: Oxytocin
Procedure: Cesarean Section
Procedure: Amniotomy
WHO partograph
Active Comparator group
Description:
Observation Amniotomy Oxytocin Cesarean Section (CS)
Treatment:
Drug: Oxytocin
Procedure: Cesarean Section
Procedure: Amniotomy

Trial contacts and locations

1

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Central trial contact

Sherif Shazly, MSc; Mohamed Abuelazm

Data sourced from clinicaltrials.gov

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