Clinical trial NCT06795685: The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts
Official title: The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Ovarian Cyst
Keywords: ultrasound
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were evaluated with serial ultrasound checks at the outpatient clinics of the division of Obstetrics and Prenatal Age Medicine of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di Sant'Orsola for the presence of suspected fetal ovarian cyst diagnosis between 2008 and 2021 will be included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn.
timeFrame: Up to 100 weeks
Secondary outcomes:
measure: Postnatal Outcomes
timeFrame: Up to 100 weeks
measure: Changes in the ultrasonographic features of the cyst in the prenatal period
timeFrame: up to 100 weeks
measure: Type of cyst on histologic examination in case of surgery
timeFrame: Up to 100 weeks
measure: Mode and type of surgery
timeFrame: Up to 100 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Elisa Montaguti, MD
role: PRINCIPAL_INVESTIGATOR
References: