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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06795685
Acronym
OVARY22
Enrollment
32
Registered
2025-01-28
Start date
2023-05-29
Completion date
2023-07-29
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Ovarian Cyst

Keywords

ultrasound

Brief 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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years

Inclusion criteria

* Single pregnancy * Age greater than or equal to 18 years * Detection of suspected fetal ovarian cyst on ultrasonography * Performance of delivery at the division of Obstetrics and Prenatal Age Medicine

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn.Up to 100 weeksThe outcome of the primary aim will be the percentage of infants who underwent surgery vs those in whom the formation went into spontaneous regression

Secondary

MeasureTime frameDescription
Postnatal OutcomesUp to 100 weeksDescription of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Changes in the ultrasonographic features of the cyst in the prenatal periodup to 100 weeksDescription of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Type of cyst on histologic examination in case of surgeryUp to 100 weeks\- mode and type of surgery Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Mode and type of surgeryUp to 100 weeksDescription of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026