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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dystocia
• Intervention / Treatment: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section

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 Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif Shazly, MSc; Phone Number: +4407554480388; Email: sherif.shazly.mogge@gmail.com
• Study Contact Backup: Name: Mohamed Abuelazm; Email: mohamed.abuelazm.mogge@gmail.com

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan faculty of medicine
    • Contact: Sherif Shazly; Phone Number: +4407554480388; Email: sherify2k2@gmail.com
    • Sub-Investigator: Mohamed Abuelazm
    • Sub-Investigator: Sarah Khaled

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine, Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.
• Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
• Gregory KD, Jackson S, Korst L, Fridman M. Cesarean versus vaginal delivery: whose risks? Whose benefits? Am J Perinatol. 2012 Jan;29(1):7-18. doi: 10.1055/s-0031-1285829. Epub 2011 Aug 10.
• Neal JL, Ryan SL, Lowe NK, Schorn MN, Buxton M, Holley SL, Wilson-Liverman AM. Labor Dystocia: Uses of Related Nomenclature. J Midwifery Womens Health. 2015 Sep-Oct;60(5):485-98. doi: 10.1111/jmwh.12355.
• HealthyPeople.gov. Search the Data | Healthy People 2020 [Internet]. 2017 [cited 2022 Mar 28]. p. 1-6. Available from: https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4660;
• Tolba SM, Ali SS, Mohammed AM, Michael AK, Abbas AM, Nassr AA, Shazly SA. Management of Spontaneous Labor in Primigravidae: Labor Scale versus WHO Partograph (SLiP Trial) Randomized Controlled Trial. Am J Perinatol. 2018 Jan;35(1):48-54. doi: 10.1055/s-0037-1605575. Epub 2017 Aug 8.
• Shazly SA, Embaby LH, Ali SS. The labour scale--assessment of the validity of a novel labour chart: a pilot study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):322-6. doi: 10.1111/ajo.12209. Epub 2014 May 17.
• Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Labor scale; Partograph; Spontaneous labor; Primigravida
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: MCOG1-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No