The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts (OVARY22)

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.

Study Overview

• Status: Completed
• Conditions: Fetal Ovarian Cyst

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn.	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	Up to 100 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Elisa Montaguti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): July 29, 2023
• Study Completion (Actual): July 29, 2023

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts
• Other Study ID Numbers: OVARY 22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No