NCT06795685

The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to investigate whether there are any prenatal ultrasound features that may predict the need for postnatal surgery versus spontaneous regression of such formations, so that better counseling can be provided to parents even in the prenatal period.

Detailed description

The rationale of the study is to define the role of prenatal ultrasonography in diagnostic framing and prognostic guidance in cases of suspected fetal ovarian cyst detection. Prenatal ultrasonography in such cases detects the presence of a pelvic formation in female fetuses, although the differential diagnosis is not always straightforward and can only be placed with certainty in the postnatal period. The investigators will therefore retrospectively assess postnatal outcomes in newborns prenatally diagnosed with ovarian cysts and investigate the presence of any prenatal ultrasound findings most associated with an unfavorable postnatal prognosis in terms of need for surgery and fetal complications. This will allow the investigators to more precisely delineate the timing of serious prenatal ultrasound checks once the diagnosis of fetal ovarian cyst is established. Ultrasound follow-up has been performed in all infants with prenatal ultrasound suspicion of ovarian cyst and continues until the cyst disappears, which occurs on average within the first six to 12 months of life. Follow-up therefore is generally 12 months, but may be discontinued early in case of earlier resolution of the cyst.

Conditions

• Fetal Ovarian Cyst

Timeline

• Start date: 2023-05-29
• Primary completion: 2023-07-29
• Completion: 2023-07-29
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: Italy