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Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.

Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06036550
Enrollment
58
Registered
2023-09-14
Start date
2021-11-11
Completion date
2022-04-06
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doppler Measurement of Uterine Artery

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.

Interventions

DIAGNOSTIC_TESTDoppler ultrasound measurement

Doppler sonographic assessment of the uterine artery was performed transabdominally. Patients underwent six sets of Doppler ultrasounds measurements of both right and left uterine artery.

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasoundBetween 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutesThe 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026