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

NCT ID: NCT06036550

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-04-06

Brief Summary

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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

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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.

Conditions

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Doppler Measurement of Uterine Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Doppler 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Philips Ultrasound Inc. Bothell, WA, USA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Wessel Ganzevoort

MD, PhD, Associate Professor, Gynaecologist-Perinatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4.

Reference Type BACKGROUND
PMID: 25175693 (View on PubMed)

Khalil A, Nicolaides KH. How to record uterine artery Doppler in the first trimester. Ultrasound Obstet Gynecol. 2013 Oct;42(4):478-9. doi: 10.1002/uog.12366. Epub 2013 May 8. No abstract available.

Reference Type BACKGROUND
PMID: 23658028 (View on PubMed)

Marchi L, Zwertbroek E, Snelder J, Kloosterman M, Bilardo CM. Intra- and inter-observer reproducibility and generalizability of first trimester uterine artery pulsatility index by transabdominal and transvaginal ultrasound. Prenat Diagn. 2016 Dec;36(13):1261-1269. doi: 10.1002/pd.4970. Epub 2016 Dec 6.

Reference Type RESULT
PMID: 27862084 (View on PubMed)

Other Identifiers

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uterine artery doppler

Identifier Type: -

Identifier Source: org_study_id

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