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

Primary Purpose

Dystocia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Amniotomy
Oxytocin
Cesarean Section
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystocia focused on measuring Labor scale, Partograph, Spontaneous labor, Primigravida

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aswan Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Labor scale

WHO partograph

Arm Description

Observation Amniotomy Oxytocin Cesarean Section (CS)

Observation Amniotomy Oxytocin Cesarean Section (CS)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Primary postpartum hemorrhage
Primary postpartum hemorrhage is defined as estimated blood loss > 500 ml following delivery and within 24 hours postpartum
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.
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)
Birth injuries of the newborn
Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn
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
Duration of labor in hours
This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery
Incidence of oxytocin use
Incidence of administration of intravenous oxytocin during labor for labor augmentation
Incidence of instrumental delivery
Instrumental delivery includes forceps and ventouse deliveries

Full Information

First Posted
April 11, 2022
Last Updated
April 16, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05341076
Brief Title
Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)
Acronym
ScaLP
Official Title
Labor Scale Versus WHO Partograph for Management of Spontaneous Labor in Primigravidae (ScaLP): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia
Keywords
Labor scale, Partograph, Spontaneous labor, Primigravida

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Labor scale
Arm Type
Experimental
Arm Description
Observation Amniotomy Oxytocin Cesarean Section (CS)
Arm Title
WHO partograph
Arm Type
Active Comparator
Arm Description
Observation Amniotomy Oxytocin Cesarean Section (CS)
Intervention Type
Procedure
Intervention Name(s)
Amniotomy
Other Intervention Name(s)
Artificial rupture of membranes
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
augmentation of labor
Intervention Description
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
Intervention Type
Procedure
Intervention Name(s)
Cesarean Section
Other Intervention Name(s)
CS
Intervention Description
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Primary Outcome Measure Information:
Title
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
Description
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia
Time Frame
Duration of labor (maximum 24 hours from onset of labor)
Secondary Outcome Measure Information:
Title
Intrapartum maternal birth injuries
Description
This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair
Time Frame
Duration of labour and hospital stay (anticipated duration: 72 hours)
Title
Primary postpartum hemorrhage
Description
Primary postpartum hemorrhage is defined as estimated blood loss > 500 ml following delivery and within 24 hours postpartum
Time Frame
Within 24 hours of delivery
Title
Maternal fever/postpartum infections
Description
This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c.
Time Frame
Within 24 hours of delivery
Title
Intrapartum fetal distress
Description
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)
Time Frame
Duration of labor (maximum 24 hours)
Title
Birth injuries of the newborn
Description
Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn
Time Frame
The length of neonatal hospital stay (anticipated duration: 72 hours)
Title
Neonatal distress "asphyxia"
Description
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
Time Frame
The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours)
Title
Duration of labor in hours
Description
This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery
Time Frame
Duration of labor (maximum 24 hours)
Title
Incidence of oxytocin use
Description
Incidence of administration of intravenous oxytocin during labor for labor augmentation
Time Frame
Duration of labor (maximum duration: 24 hours)
Title
Incidence of instrumental delivery
Description
Instrumental delivery includes forceps and ventouse deliveries
Time Frame
Duration of labor (maximum duration: 24 hours)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
N/A (study targets pregnant women in labor)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif Shazly, MSc
Phone
+4407554480388
Email
sherif.shazly.mogge@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abuelazm
Email
mohamed.abuelazm.mogge@gmail.com
Facility Information:
Facility Name
Aswan Faculty of Medicine
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif Shazly
Phone
+4407554480388
Email
sherify2k2@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Abuelazm
First Name & Middle Initial & Last Name & Degree
Sarah Khaled

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24565430
Citation
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.
Results Reference
background
PubMed Identifier
23400611
Citation
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.
Results Reference
background
PubMed Identifier
21833896
Citation
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.
Results Reference
background
PubMed Identifier
26461188
Citation
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.
Results Reference
background
Citation
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;
Results Reference
background
PubMed Identifier
28787749
Citation
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.
Results Reference
background
PubMed Identifier
24835694
Citation
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.
Results Reference
background
PubMed Identifier
30080256
Citation
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.
Results Reference
background

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

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