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

September 7, 2023 updated by: Wessel Ganzevoort, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Amsterdam University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All women with a first-trimester singleton pregnancy receiving a Doppler ultrasound at the outpatient clinic are eligible.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

April 6, 2022

Study Completion (Actual)

April 6, 2022

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • uterine artery doppler

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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