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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dystocia

Intervention / Treatment
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* Procedure: Amniotomy
* Drug: Oxytocin
* Procedure: Cesarean Section


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Labor scale<br>Observation Amniotomy Oxytocin Cesarean Section (CS) | Procedure: Amniotomy<br>* 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)<br>* Other names: Artificial rupture of membranes;Drug: Oxytocin<br>* oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)<br>* Other names: augmentation of labor;Procedure: Cesarean Section<br>* Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)<br>* Other names: CS;|
| Active Comparator: WHO partograph<br>Observation Amniotomy Oxytocin Cesarean Section (CS) | Procedure: Amniotomy<br>* 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)<br>* Other names: Artificial rupture of membranes;Drug: Oxytocin<br>* oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)<br>* Other names: augmentation of labor;Procedure: Cesarean Section<br>* Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)<br>* Other names: CS;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapartum maternal birth injuries | This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair | Duration of labour and hospital stay (anticipated duration: 72 hours) | 
| Primary postpartum hemorrhage | Primary postpartum hemorrhage is defined as estimated blood loss > 500 ml following delivery and within 24 hours postpartum | Within 24 hours of delivery | 
| Maternal fever/postpartum infections | This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c. | Within 24 hours of delivery | 
| Intrapartum fetal distress | 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) | Duration of labor (maximum 24 hours) | 
| Birth injuries of the newborn | Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn | The length of neonatal hospital stay (anticipated duration: 72 hours) | 
| Neonatal distress asphyxia | 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 | The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours) | 
| Duration of labor in hours | This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery | Duration of labor (maximum 24 hours) | 
| Incidence of oxytocin use | Incidence of administration of intravenous oxytocin during labor for labor augmentation | Duration of labor (maximum duration: 24 hours) | 
| Incidence of instrumental delivery | Instrumental delivery includes forceps and ventouse deliveries | Duration of labor (maximum duration: 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor scale, Partograph, Spontaneous labor, Primigravida