- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Antonia Carla Testa
- Telefonnummer: +390630156399
- E-post: antoniacarla.testa@policlinicogemelli.it
Studieorter
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Huvudutredare:
- Antonia Carla Testa, prof
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Kontakt:
- ANTONIA CARLA TESTA, Professor
- Telefonnummer: +390630156399
- E-post: antoniacarla.testa@policlinicogemelli.it
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Complication Rate in Conservatively Managed Fetal Ovarian Cysts
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Antonia Carla Testa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 27206
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