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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Antonia Carla Testa
- Número de teléfono: +390630156399
- Correo electrónico: antoniacarla.testa@policlinicogemelli.it
Ubicaciones de estudio
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Investigador principal:
- Antonia Carla Testa, prof
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Contacto:
- ANTONIA CARLA TESTA, Professor
- Número de teléfono: +390630156399
- Correo electrónico: antoniacarla.testa@policlinicogemelli.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Complication Rate in Conservatively Managed Fetal Ovarian Cysts
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Antonia Carla Testa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 27206
Información sobre medicamentos y dispositivos, documentos del estudio
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