About this trial
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 criteria
Qualifiers
• 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.
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- Ultrasound