Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05463536 |
| Other study ID # |
S66486 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Bram Packet, MD |
| Phone |
00321648824 |
| Email |
bram.packet[@]kuleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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. 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. Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG
and watching the corresponding teaching video.
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. 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).
Description:
1. Participant recruitment: Relevant caregivers will be invited to participate in this
trial during their regular daytime shifts on the labor ward. One of the study
investigators will explain the goal of the study and they will be given the opportunity
to ask questions. Trainees willing to participate will be asked to sign the informed
consent form.
All women admitted on the labor ward in spontaneous labor or for planned induction of
labor will be informed about the scope and purpose of this study by either the attending
clinicians (obstetric caregivers, trial participants) or study investigators. An
information leaflet was designed for this purpose and will be made available to the
patients at the time of admission on the labor ward.
2. Trial Procedures:
2.1 Observational Phase: Ultrasound is considered a more reliable tool for assessing labor
progress compared to clinical examination. We first want to conduct an internal audit to
measure the accuracy of clinical assessments of fetal head position/station throughout labor
by caregivers working in our department. For each trainee, 20 observations will be carried
out where they will be asked to clinically assess fetal head position and station at
different time points in labor. These observations will be carried out in different subjects
and only on fetuses > 37 weeks of gestation, in cephalic presentation and with ruptured
membranes.
Immediately after their examination, an experienced sonographer will verify their findings by
means of an ultrasound scan (=reference standard). Both examinations will be carried out
under the same conditions (absence of uterine contractions or maternal pushing efforts) to
ensure comparability of findings. Fetal head position will be classified into three
categories: occiput anterior, occiput transverse of occiput posterior (similarly for clinical
and ultrasound assessment). The distance from the ischial spines (in centimeters) will be
used to assess fetal head station clinically. The Angle of Progression (AoP) will be used to
assess station by (trans-perineal) ultrasound.
2.2 Training
The goal is to improve ultrasound skills among caregivers working in our department by
implementing a standardized training course. This will have the following components:
2.2.1 Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG
and watching the corresponding teaching video.
2.2.2 Supervised implementation: during the next round of observations, trainees will be
asked to perform ultrasound scans during labor to assess fetal head position and station
under direct supervision of an expert sonographer, providing immediate feedback on scanning
technique and acquisitioning (probe placement, probe handling, machine settings, etc.).
Supervised observations will be carried out until the trainee is deemed "fit" for independent
acquisitioning, I.e., a pass/fail system will be used, and the number of supervised
observations needed to obtain a pass will be recorded for every trainee.
2.3 Proficiency testing: Similar to the observational phase, where trainees will now be asked
to assess fetal head position and station both clinically and by ultrasound. Scans will be
repeated by the supervising sonographer and findings will either by concordant or discordant
(binary outcome). Cumulative Sum (CUSUM) analysis will be used to monitor the learning curve.
We estimate roughly 20 observations will be needed for trainees with prior (obstetrical)
ultrasound experience to reach proficiency. In trainees without any previous ultrasound
experience (first year residents with no previous exposure), we estimate about 50
observations will be needed.
The following criteria will be taken into consideration for quality assessment of the
trainee's performance:
- Fetal head station: AoP acquisition is acceptable when all the following conditions are
met:
1. Correct midsagittal plane: central nucleus of the symphysis joint visible, pubic
rami not visible, symphysis pubis as horizontal as possible.
2. Leading part of the fetal skull visible (with parts of the anterior and posterior
tabula).
3. Caliper placement with the 3-point technique to measure the AoP.
The following variables will also be recorded:
- AoP acquisition time: time between probe placement on the skin and obtaining
the best image for quantitative assessment (trainee's call to freeze the image
for analysis) (seconds).
- Delta-AoP: absolute difference in the AoP measurement obtained by the trainee
and the supervising sonographer (°)
- Assessment of engagement (yes/no): either concordant or discordant with the
supervisor's opinion.
- Fetal head position: sonographic assessment of the trainee will either be concordant or
discordant with the expert opinion.
2.4 Kap assessment:
A purposely designed questionnaire will be used to objectify knowledge, attitude and
practices regarding intrapartum ultrasound use throughout the different stages of the
training program. These KAP assessments will be conducted at the following time points:
1. Prior to the self-study
2. After the self-study and in-person teaching (supervised implementation)
3. When competency/proficiency is declared.
2.5 The following clinical variables will be recorded at every observation throughout the
different stages of the training program: Pre-pregnancy BMI, Gestational weight gain (kg),
Gestational age (weeks), Epidural Analgesia, Parity (Nulliparous / Multiparous), Delivery
mode (first stage cesarean section, 2nd stage cesarean section, spontaneous vaginal delivery,
assisted vaginal delivery), Neonatal birth weight (grams), Neonatal head circumference (cm),
Stage of labor (first (latent, active) or second), Examination to delivery interval
(minutes), Cervical dilatation (cm), Angle of Progression (°), Occiput-Spine-Angle or
Chin-Chest-Angle (OSA or CCA) (°), Presence of fetal caput (mm), Presence of fetal skull
molding (yes/no).
3. Statistics
3.1 Sample size: This is a pilot study with no previously published data on this topic. We
aim to achieve a total sample size of about 20 participants. Previous studies on teaching
strategies for point of care ultrasound in obstetrics (not intrapartum ultrasound) were able
to demonstrate good efficacy of training programs in similar sample sizes (Shah S, et al.
PLoS One. 2020;15(6) - Wanjiku GW, et al. BMJ Health Serv Res. 2018;18(1)).
We aim for the first round of inclusions to take place in 10/2022 with inclusion of
approximately 10 trainees. In 02/2022, a second round of inclusions will take place with
another estimate of 10 trainees. This will allow us to reach our full sample size by the end
of 2023. Observations/Proficiency testing will take place during office hours, 5 days a week.
The expected total duration of participation of a subject (trainee) will be approximately 6
months.
3.2 Statistical Analysis
3.2.1 Primary endpoint: Cumulative Sum analysis (CUSUM) was originally developed as a tool
for quality control assessment of production pipelines in industry. However, as described by
Bolsin and Noyez, it can also be used as an instrument to assess competency among trainees
learning a new skill (Bolsin S, Colson M. Int J Qual Heal care. 2000;12(5):433-8. - Noyez L.
Heal Care Curr Rev. 2014;02(01):2-4). It allows for an objective assessment of performance
accuracy on a case-by-case basis.
A cumulative performance score is typically plotted against the number of observations, so
that trends in sequential measurements can be evaluated over time. CUSUM analysis can only be
performed with a binary outcome (operation success or failure). In our study, operation
success is typically defined as diagnostic agreement with the expert, whereas operation
failure is defined as the opposite. Both types of events are assigned a certain value, and
the CUSUM score is the running sum of a mixture of increments (with each failure) and
decrements (with each success). These values can be plotted on the y-axis against the number
of attempts on the x- axis. Horizontal lines are then plotted at regular intervals on the
y-axis, defining h1 (the spacing between unacceptable boundary lines) and h0 (the spacing
between acceptable boundary lines).
The gradient and overall height of the plot derived provides feedback on performance on a
case-by case basis. If the reference value is specified in terms of an acceptable failure
rate (see below), the CUSUM score will increase and create a positive slope when operation
failure is higher than the target value, whereas operation success will decrease the score
and create a negative slope.
Competence can be declared when the graph falls below the lower boundary of h0, i.e.,
dropping below two consecutive boundary lines; loss of competence is declared when the graph
ascends above the upper boundary of h1, i.e. rising above two consecutive boundary lines.
The acceptable and unacceptable failure rate (p0 and p1) should typically be set according to
the gold standard (i.e., determined by previous cohort studies or specified by recognized
governing bodies).Type 1 and type 2 error rates are typically set at the same value of 0.1 by
common convention. This has the advantage of producing identical positive and negative
performance thresholds, simplifying CUSUM charts and making interpretation easier.
In our study, we will set the acceptable failure rate for the sonographic assessment of fetal
head position and descent at 0.02, based on previous studies by Hassan WA, et al (Ultrasound
Obstet Gynecol. 2014;43(2):189-94) and Tang H, et al (Int J Gynecol Obstet. 2021;(0):1-6).
The unacceptable failure rate typically ranges between 2 to 5 times the acceptable failure
rate (by consensus) and will be set at 0,10 in our study.
3.2.2 Secondary endpoints: Differences in learning curves according to the trainee's
experience level (for both primary endpoints), will be assessed by visual inspection of the
CUSUM charts.
Failure rates of the clinical assessments during the baseline observational phase will be
calculated for every trainee. Descriptive statistics (frequencies, proportions) will be used
for this purpose We will try and identify confounding factors associated with
correct/incorrect clinical assessment by comparing patient related, neonatal related and
obstetrical variables among these groups (as outlined above). The Mann-Whitney U test,
unpaired T test, McNemar's test or Chi-square test will be used when relevant. We will use
logistic regression to assess associations between demographical and obstetrical parameters
and accuracy of clinical examination. Variables associated with accuracy of assessment on
univariate analysis will be considered for a multivariable logistic regression model.
For all trainees, Delta-AoP will be plotted against the round of observation to plot for an
alternative "learning curve". The same will be done for acquisitioning times. Mean
acquisition time between the first and last ten blocks of observations will be compared for
each trainee using the Mann-Whitney U test. P values < 0.05 will be considered statistically
significant.
4. Ethics and regulatory approvals: The trial will be conducted in compliance with the
principles of the Declaration of Helsinki (2013), the principles of GCP and in accordance
with all applicable regulatory requirements. This protocol and related documents will be
submitted for review to Ethics Committee of the University Hospital Leuven.
The study is conducted only on the basis of prior informed consent by the subjects to
participate in the study. The investigator shall obtain a signed informed consent form (ICF)
for all patients prior to their enrolment and participation in the study in compliance with
all applicable laws, regulations and the approval of the Ethics Committee. The investigator
shall retain such ICFs in accordance with the requirements of all applicable regulatory
agencies and laws.
The Investigators shall treat all information and data relating to the study disclosed to
them on this study as confidential and shall not disclose such information to any third
parties or use such information for any purpose other than the performance of the study. The
collection, processing and disclosure of personal data, such as patient health and medical
information are subject to compliance with applicable personal data protection and the
processing of personal data (The General Data Protection Regulation (EU) 2016/679 (GDPR)).
5. Data Handling and Management: The recording system used to collect the data has limited
access measures by usernames and passwords. Data will be collected electronically and the
saved data will be hosted at UZ Leuven, in the domain allocated to the PI. This is a
password-protected domain and access will be only possible to the personnel involved in the
study (PI, sub-investigator, administrator). Published results will not contain any personal
data that could allow the identification of individual participants.
