Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-04 @ 6:12 PM
Study NCT ID:
NCT06036550
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2023-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Doppler Measurement of Uterine Artery']}, 'referencesModule': {'references': [{'pmid': '25175693', 'type': 'BACKGROUND', '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.'}, {'pmid': '23658028', 'type': 'BACKGROUND', '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.'}, {'pmid': '27862084', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women with a first-trimester singleton pregnancy receiving a Doppler ultrasound at the outpatient clinic are eligible.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy\n* Gestational age from 11+0 weeks to 13+6 weeks\n\nExclusion Criteria:\n\n* Maternal age \\<18 years\n\n * Inability to give informed consent\n * Multiple pregnancy\n * Abnormal fetal heart tracings\n * Non-viable pregnancy'}, 'identificationModule': {'nctId': 'NCT06036550', 'briefTitle': 'Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.', 'orgStudyIdInfo': {'id': 'uterine artery doppler'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Doppler ultrasound measurement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Philips Ultrasound Inc. Bothell, WA, USA'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor, Gynaecologist-Perinatologist', 'investigatorFullName': 'Wessel Ganzevoort', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}