Improvings: Implementing a Protocol to Improve Intrapartum Sonography Skills.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proficiency for the sonographic assessment of fetal head station during labor.
研究概览
简要总结
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:
- 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.
- Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG and watching the corresponding teaching video.
- 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.
- 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).
详细描述
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obstetric caregivers, willing to participate in the study (to give written informed consent).
排除标准
- •Trainees refusing to participate (refusing to give written informed consent).
结局指标
主要结局
Proficiency for the sonographic assessment of fetal head station during labor.
时间窗: Through study completion, estimated at 12 months.
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.
Proficiency for the sonographic assessment of fetal head position during labor.
时间窗: Through study completion, estimated at 12 months.
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.
次要结局
- Determinants of accuracy clinical assessment fetal head position/station(On completion of the observational phases by all recruited trainees, 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.)
- 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).)
- Delta-AoP (Angle of Progression)(On study completion, estimated at 12 months.)