- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07587580
Fetal Ovarian Cysts and IOTA Terminology for Perinatal Management (F-IOTA)
Fetal Ovarian Cysts: Application of the International Ovarian Tumor Analysis (IOTA) Terminology and Implications for Perinatal Management
Fetal ovarian cysts are common prenatal findings with a highly variable clinical course, ranging from spontaneous resolution to complications such as torsion, hemorrhage, or rupture requiring surgery. Current prenatal classification is mainly based on the distinction between "simple" and "complex" cysts; however, this approach may be insufficient to accurately predict outcomes and guide perinatal management.
This multicenter prospective observational study aims to validate a management model based on the International Ovarian Tumor Analysis (IOTA) terminology for ultrasound characterization of fetal ovarian cysts. Pregnant women carrying a fetus with an ovarian cyst will be enrolled and followed with serial ultrasound examinations during pregnancy and after birth. Cysts will be classified according to morphology and cyst content (anechoic, low-level, ground-glass, hemorrhagic, mixed, and others) and managed according to a predefined protocol based on cyst size and ultrasound features.
The primary objective is to assess the rate of complications requiring postnatal surgery in conservatively managed fetal ovarian cysts with anechoic or low-level cystic content smaller than 4 cm. Secondary objectives include evaluation of complication rates in larger cysts managed with aspiration procedures, rates of spontaneous cyst resolution, rates of ovarian torsion, and the presence of normal ovarian parenchyma at histology in surgically treated cases.
The study aims to improve prenatal risk stratification and optimize perinatal management in order to reduce unnecessary surgery and preserve ovarian function.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Antonia Carla Testa
- Numéro de téléphone: +390630156399
- E-mail: antoniacarla.testa@policlinicogemelli.it
Lieux d'étude
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Roma, Italie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Chercheur principal:
- Antonia Carla Testa, prof
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Contact:
- ANTONIA CARLA TESTA, Professor
- Numéro de téléphone: +390630156399
- E-mail: antoniacarla.testa@policlinicogemelli.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Pregnant women aged ≥18 years Singleton or multiple pregnancies with fetal ovarian cyst diagnosed by prenatal ultrasound at any gestational age Signed informed consent
Exclusion Criteria:
Refusal to provide informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Conservative Management
Fetal ovarian cysts with unilocular anechoic or low-level cystic content measuring less than 4 cm at enrollment, managed conservatively with serial ultrasound follow-up every two weeks during pregnancy and after birth unless changes in morphology or increase in size occur.
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Aspiration Management
Fetal ovarian cysts with unilocular anechoic or low-level cystic content measuring more than 4 cm, managed either by intrauterine aspiration or postnatal laparoscopic aspiration, with serial ultrasound follow-up every two weeks.
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Surgical Management
Fetal ovarian cysts with ground-glass appearance, hemorrhagic content, mixed echogenicity, or other complex ultrasound features, monitored during pregnancy and surgically managed after birth according to clinical evaluation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Complication Rate in Conservatively Managed Fetal Ovarian Cysts
Délai: From enrollment through 2 weeks postnatal follow-up
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Proportion of fetal ovarian cysts with anechoic or low-level content and diameter <4 cm at enrollment that develop complications requiring postnatal surgical intervention, including changes in cyst morphology during pregnancy or after birth.
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From enrollment through 2 weeks postnatal follow-up
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Antonia Carla Testa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 27206
Informations sur les médicaments et les dispositifs, documents d'étude
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