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

Dystocia Clinical Trial

— ScaLP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341076
• Other study ID #: MCOG1-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Sherif Shazly, MSc
• Phone: +4407554480388
• Email: sherif.shazly.mogge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystocia

Intervention

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)

Drug:
• Oxytocin
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)

Procedure:
• Cesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)

Locations

Country	Name	City	State
Egypt	Aswan Faculty of Medicine	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View 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. Review. — View 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. — View 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;

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:CD005461. doi: 10.1002/14651858.CD005461.pub5. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Incidence of oxytocin use	Incidence of administration of intravenous oxytocin during labor for labor augmentation	Duration of labor (maximum duration: 24 hours)
Secondary	Incidence of instrumental delivery	Instrumental delivery includes forceps and ventouse deliveries	Duration of labor (maximum duration: 24 hours)