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

Completed

• Conditions: Fetal Ovarian Cyst

• Registration Number: NCT06795685
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2023-05-29
• Primary Completion: 2023-07-29
• Study Completion: 2023-07-29
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn.	Up to 100 weeks	The 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 Outcome Measures

Name	Time	Method
Postnatal Outcomes	Up to 100 weeks	Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Changes in the ultrasonographic features of the cyst in the prenatal period	up to 100 weeks	Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Type of cyst on histologic examination in case of surgery	Up to 100 weeks	- mode and type of surgery; Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Mode and type of surgery	Up to 100 weeks	Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy