RecruitingNCT05974618

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)

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).

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,000 participants

Start Date

Jun 5, 2023

Study Type

OBSERVATIONAL

Conditions

Adnexal Cyst Adnexal Mass Adnexal Tumor Pregnancy Related

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)

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

• Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension;
In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound;
Previously recruited patient presenting with a different mass in subsequent pregnancy;
Age 18 years and above.

Exclusion Criteria5

• Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);
Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;
The denial or withdrawal of written informed consent;
Same cyst already recruited for p-IOTA in a previous pregnancy.
Age \< 18 years

Interventions

DIAGNOSTIC_TESTUltrasound

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.