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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)

NCT05974618 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-08-03

No results posted yet for this study

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)

Conditions

  • Adnexal Mass
  • Adnexal Tumor
  • Adnexal Cyst
  • Pregnancy 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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974618 on ClinicalTrials.gov