Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)
ScaLP
1 other identifier
interventional
206
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedApril 22, 2022
April 1, 2022
11 months
April 11, 2022
April 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Intrapartum maternal birth injuries
Duration of labour and hospital stay (anticipated duration: 72 hours)
Primary postpartum hemorrhage
Within 24 hours of delivery
Maternal fever/postpartum infections
Within 24 hours of delivery
Intrapartum fetal distress
Duration of labor (maximum 24 hours)
Birth injuries of the newborn
The length of neonatal hospital stay (anticipated duration: 72 hours)
- +4 more secondary outcomes
Study Arms (2)
Labor scale
EXPERIMENTALObservation Amniotomy Oxytocin Cesarean Section (CS)
WHO partograph
ACTIVE COMPARATORObservation Amniotomy Oxytocin Cesarean Section (CS)
Interventions
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 augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aswan Faculty of Medicine
Aswān, 81528, Egypt
Related 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.
PMID: 24565430BACKGROUNDHamilton 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.
PMID: 23400611BACKGROUNDGregory 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.
PMID: 21833896BACKGROUNDNeal 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.
PMID: 26461188BACKGROUNDHealthyPeople.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;
BACKGROUNDTolba 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.
PMID: 28787749BACKGROUNDShazly 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.
PMID: 24835694BACKGROUNDLavender 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.
PMID: 30080256BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.B.B.Ch, M.S.c
Study Record Dates
First Submitted
April 11, 2022
First Posted
April 22, 2022
Study Start
August 1, 2022
Primary Completion
July 1, 2023
Study Completion
September 1, 2023
Last Updated
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share