Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound
Study Overview
Brief Summary
The aim of this study is to investigate the inter- and intra-observer variability of first-trimester Uterine Artery Doppler ultrasound measurements in pregnancies between 11+0 and 13+0 weeks of gestation. Participants will undergo a measurement protocol (six sets of Doppler ultrasounds measurements of right and left uterine artery) performed alternately by two observers (sonographers or physicians who perform these ultrasounds frequently in clinical practice at the outpatient clinic).
Detailed Description
Doppler ultrasound measurements are increasingly performed in clinical practice to detect high-risk pregnancies. First-trimester uterine artery Doppler measurement might be a potential predictor for the development of maternal hypertensive disorders later on in pregnancy. However, before implementing this measurement into clinical practice and prediction models, the test characteristics of this first-trimester Doppler measurements should be adequately studied. The objective is to assess the inter- and intra-observer variability of first-trimester uterine Doppler ultrasound measurements.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancy
- •Gestational age from 11+0 weeks to 13+6 weeks
Exclusion Criteria
- •Maternal age <18 years
- •Inability to give informed consent
- •Multiple pregnancy
- •Abnormal fetal heart tracings
- •Non-viable pregnancy
Outcomes
Primary Outcomes
Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound
Time Frame: Between 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutes
The aim of this study is to investigate the inter- and intra-observer variability of first-trimester Uterine Artery Doppler ultrasound measurements, according to the TRUST-study criteria for reproducibility assessment and analysis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Wessel Ganzevoort
MD, PhD, Associate Professor, Gynaecologist-Perinatologist
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)