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

NCT ID: NCT05341076

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-09-01

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.

Conditions

Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Labor scale

Observation Amniotomy Oxytocin Cesarean Section (CS)

Group Type: EXPERIMENTAL

Amniotomy

Intervention Type: PROCEDURE

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)

Oxytocin

Intervention Type: DRUG

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

Cesarean Section

Intervention Type: PROCEDURE

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

WHO partograph

Observation Amniotomy Oxytocin Cesarean Section (CS)

Group Type: ACTIVE_COMPARATOR

Amniotomy

Intervention Type: PROCEDURE

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)

Oxytocin

Intervention Type: DRUG

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

Cesarean Section

Intervention Type: PROCEDURE

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

Interventions

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)

Intervention Type: PROCEDURE

Oxytocin

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

Intervention Type: DRUG

Cesarean Section

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

Intervention Type: PROCEDURE

Other Intervention Names

Artificial rupture of membranes; augmentation of labor; CS

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Abdelkarim Mohammed Shazly

M.B.B.Ch, M.S.c

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aswan Faculty of Medicine

Aswān, , Egypt

Countries

Egypt

Central Contacts

Sherif Shazly, MSc

Role: CONTACT

sherif.shazly.mogge@gmail.com

+4407554480388

Mohamed Abuelazm

Role: CONTACT

mohamed.abuelazm.mogge@gmail.com

Facility Contacts

Sherif Shazly

Role: primary

sherify2k2@gmail.com

+4407554480388

References

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.

Reference Type: BACKGROUND

PMID: 24565430 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23400611 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21833896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26461188 (View on PubMed)

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;

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28787749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24835694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30080256 (View on PubMed)

Other Identifiers

MCOG1-22

Identifier Type: -

Identifier Source: org_study_id