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

Completed

• Conditions: Doppler Measurement of Uterine Artery

• Registration Number: NCT06036550
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 Timeline

• Study Start: 2021-11-11
• Primary Completion: 2022-04-06
• Study Completion: 2022-04-06
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound	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.

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands