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

Not Applicable

• Conditions: Dystocia
• Interventions: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section

• Registration Number: NCT05341076
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-16
• Last Update Submitted: 2022-04-16
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Study Start: 2022-08-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WHO partograph	Amniotomy	Observation Amniotomy Oxytocin Cesarean Section (CS)
WHO partograph	Oxytocin	Observation Amniotomy Oxytocin Cesarean Section (CS)
Labor scale	Amniotomy	Observation Amniotomy Oxytocin Cesarean Section (CS)
Labor scale	Oxytocin	Observation Amniotomy Oxytocin Cesarean Section (CS)
Labor scale	Cesarean Section	Observation Amniotomy Oxytocin Cesarean Section (CS)
WHO partograph	Cesarean Section	Observation Amniotomy Oxytocin Cesarean Section (CS)

Primary Outcome Measures

Name	Time	Method
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)	Duration of labor (maximum 24 hours from onset of labor)	The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia

Secondary Outcome Measures

Name	Time	Method
Primary postpartum hemorrhage	Within 24 hours of delivery	Primary postpartum hemorrhage is defined as estimated blood loss \> 500 ml following delivery and within 24 hours postpartum
Intrapartum fetal distress	Duration of labor (maximum 24 hours)	This criterion is met if cardiotocography shows signs consistent with pathological tracing as defined by NICE guidelines (persistent late or variable decelerations, prolonged bradaycardia or sinusoidal rhythm)
Birth injuries of the newborn	The length of neonatal hospital stay (anticipated duration: 72 hours)	Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn
Maternal fever/postpartum infections	Within 24 hours of delivery	This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c.
Intrapartum maternal birth injuries	Duration of labour and hospital stay (anticipated duration: 72 hours)	This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair
Neonatal distress "asphyxia"	The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours)	This is indicated by 1 and 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to neonatal intensive care unit, length of stay and any further medical complications
Duration of labor in hours	Duration of labor (maximum 24 hours)	This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery
Incidence of oxytocin use	Duration of labor (maximum duration: 24 hours)	Incidence of administration of intravenous oxytocin during labor for labor augmentation
Incidence of instrumental delivery	Duration of labor (maximum duration: 24 hours)	Instrumental delivery includes forceps and ventouse deliveries

Trial Locations

Locations (1)

Aswan Faculty of Medicine; 🇪🇬 Aswan, Egypt