Improvings: Implementing a Protocol to Improve Intrapartum Sonography Skills.

NCT05463536 | Recruiting

• 1 other identifier: S66486
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational cohort study on the learning curve for the sonographic assessment of labor progress (fetal head position and station) amongst obstetric caregivers. Study participants: convenience sample of 20 obstetric caregivers working in the department of obstetrics and gynecology at the University Hospital of Leuven - recruited over a 12-month period. Format of the training program:

1. 1.Observational phase: the goal is to measure the accuracy of the clinical assessment of fetal head position and station throughout the different stages of labor by caregivers working within the department.
2. 2.Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG and watching the corresponding teaching video.
3. 3.Supervised implementation phase: one-to-one teaching by experienced sonographers, who initially demonstrate, later interactively supervise the quality of the scans acquired by the obstetric caregiver.
4. 4.Proficiency testing: from this point onwards, the trainee independently performs ultrasound scans in labor to asses fetal head position and station. The scans will be repeated by the expert sonographer, the results will be compared (qualitatively and quantitatively) and immediate feedback provided if indicated. Every observation will have a binary outcome (success or failure of trainee acquisition) according to predefined quality assessment criteria. Observations will be continued until proficiency is reached (saturation of the learning curve).

Conditions

Obstetric Labor

Outcome Measures

Primary Outcomes (2)

• Proficiency for the sonographic assessment of fetal head station during labor.

  Number of ultrasound examinations a caregiver needs to perform under expert supervision to obtain proficiency - defined as the CUSUM (Cumulative Sum analysis) performance graph dropping below two consecutive boundary lines.

  Through study completion, estimated at 12 months.

• Proficiency for the sonographic assessment of fetal head position during labor.

  Number of ultrasound examinations a caregiver needs to perform under expert supervision to obtain proficiency - defined as the CUSUM (Cumulative Sum analysis) performance graph dropping below two consecutive boundary lines.

  Through study completion, estimated at 12 months.

Secondary Outcomes (5)

• Knowledge, attitude and practices regarding intrapartum ultrasound use.

  Assessed at three timepoints: once at inclusion, once after the training phase (esimated three months after inclusion) and one final assessment at completion of the training program (when proficiency is declared, estimated at 6 months).

• Differences in learning curves according to training level (years of residency / clinical experience).

  On study completion, estimated at 12 months.

• Differences in learning curves for the sonographic assessment of fetal head station vs. fetal head position.

  On study completion, estimated at 12 months.

• Delta-AoP (Angle of Progression)

  On study completion, estimated at 12 months.

• Determinants of accuracy clinical assessment fetal head position/station

  On completion of the observational phases by all recruited trainees, estimated at 6 months.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstetric caregivers working within the department of obstetrics and gynecology at the University Hospital of Leuven.

You may qualify if:

• Obstetric caregivers, willing to participate in the study (to give written informed consent).

You may not qualify if:

• Trainees refusing to participate (refusing to give written informed consent).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, department of obstetrics and gynaecology

Leuven, 3000, Belgium

RECRUITING

Study Officials

• Jute Richter, MD, PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

• Jan Deprest, MD, PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Packet, MD

CONTACT

00321648824; bram.packet@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 19, 2022
• Study Start: July 7, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)