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)

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Adnexal MassAdnexal TumorAdnexal CystPregnancy Related
Interventions
DIAGNOSTIC_TEST

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."

Trial Locations (1)

3000

RECRUITING

UZ Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER