Clinical trial NCT06036550: Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.
Official title: Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Doppler Measurement of Uterine Artery
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women with a first-trimester singleton pregnancy receiving a Doppler ultrasound at the outpatient clinic are eligible.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound
timeFrame: Between 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord-Holland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.