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Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy: International Ovarian Tumour Analysis in pregnancy study (p-IOTA)
Official title: Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-06-05
Completion Date
2026-07
Last Updated
2023-08-03
Healthy Volunteers
Not specified
Interventions
Ultrasound
A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.
Locations (1)
UZ Leuven
Leuven, Vlaams-Brabant, Belgium