AzTrials
AzTrials

DystociaScaLPNCT05341076

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

A study testing Amniotomy, Oxytocin and Cesarean Section in people with Dystocia, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Dystocia
What is being tested?
Amniotomy, Oxytocin and Cesarean Section
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteEgypt
Study dates
1 Aug 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

1 site in 1 country.

Sherif Shazly, MSc contact

+4407554480388

sherif.shazly.mogge@gmail.com

Mohamed Abuelazm contact

mohamed.abuelazm.mogge@gmail.com

Egypt1 site

  • Aswan Faculty of Medicine

    Aswān, 81528

    Sherif Shazly, +4407554480388, sherify2k2@gmail.com

    Mohamed Abuelazm

Other trials in Egypt

About this study

Official title: 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.

Read the 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
Being tested
Amniotomy, Oxytocin, Cesarean Section
Keywords
Labor scale, Partograph, Spontaneous labor, Primigravida
Medical subject headings
Dystocia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmniotomyProcedure or surgery

    Also called Artificial rupture of membranes

    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)

  • OxytocinDrug

    Also called augmentation of labor

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

  • Cesarean SectionProcedure or surgery

    Also called CS

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

Study groups in NCT05341076
Study groupRoleWhat they receive
Labor scaleExperimentalObservation Amniotomy Oxytocin Cesarean Section (CS)
Receives: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section
WHO partographActive comparatorObservation Amniotomy Oxytocin Cesarean Section (CS)
Receives: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Duration of labor (maximum 24 hours from onset of labor)

Secondary outcomes (9)

  1. 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

    Measured: Duration of labour and hospital stay (anticipated duration: 72 hours)

  2. Primary postpartum hemorrhage

    Primary postpartum hemorrhage is defined as estimated blood loss > 500 ml following delivery and within 24 hours postpartum

    Measured: Within 24 hours of delivery

  3. 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.

    Measured: Within 24 hours of delivery

  4. 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)

    Measured: Duration of labor (maximum 24 hours)

  5. Birth injuries of the newborn

    Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn

    Measured: The length of neonatal hospital stay (anticipated duration: 72 hours)

  6. 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

    Measured: The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours)

  7. Duration of labor in hours

    This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery

    Measured: Duration of labor (maximum 24 hours)

  8. Incidence of oxytocin use

    Incidence of administration of intravenous oxytocin during labor for labor augmentation

    Measured: Duration of labor (maximum duration: 24 hours)

  9. Incidence of instrumental delivery

    Instrumental delivery includes forceps and ventouse deliveries

    Measured: Duration of labor (maximum duration: 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05341076
Sponsor's protocol ID
MCOG1-22
Acronym
ScaLP
Status last verified
Apr 2022
First submitted
11 Apr 2022
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24565430

  • 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.

    PubMed 23400611

  • 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.

    PubMed 21833896

  • 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.

    PubMed 26461188

  • 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.

    PubMed 28787749

  • 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.

    PubMed 24835694

  • 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.

    PubMed 30080256

Questions about this trial

What is this clinical trial studying?

A study testing Amniotomy, Oxytocin and Cesarean Section in people with Dystocia, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sherif Shazly, MSc (+4407554480388, sherif.shazly.mogge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) (time frame: Duration of labor (maximum 24 hours from onset of labor)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05341076, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in