Fetal Ovarian CystOVARY22NCT06795685
The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts
An observational study of Fetal Ovarian Cyst, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Ovarian Cyst
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2023to 29 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- ultrasound
- Medical subject headings
- Neonatal ovarian cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 100 weeks
Secondary outcomes (4)
Postnatal Outcomes
Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Measured: 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
Measured: 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
Measured: Up to 100 weeks
Mode and type of surgery
Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst
Measured: Up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start29 May 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Ovarian CystStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Montaguti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795685
- Sponsor's protocol ID
- OVARY 22
- Acronym
- OVARY22
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pre-natal Ultrasound in Predicting Outcomes of Fetal Ovarian Cysts
- ClinicalTrials.gov ID
- NCT06795685
- Acronym / sponsor ID
- OVARY22 / OVARY 22
- Conditions
- Fetal Ovarian Cyst
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn.
Time frame: 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
4 secondary outcomes
Postnatal Outcomes
Time frame: Up to 100 weeks
Changes in the ultrasonographic features of the cyst in the prenatal period
Time frame: up to 100 weeks
Type of cyst on histologic examination in case of surgery
Time frame: Up to 100 weeks
Mode and type of surgery
Time frame: Up to 100 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Fetal Ovarian Cysts and IOTA Terminology for Perinatal Management
Fetal Ovarian Cyst, Neonatal Ovarian Cyst
RecruitingObservational study
PEPPI Study: Identification of Women at Risk for Placental Dysfunction
Pre-Eclampsia, Intrauterine Growth Restriction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Montaguti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Ovarian Cyst, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between ovarian cyst characteristics and the performance of cyst excision surgery on the newborn. (time frame: Up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.