NCT06795685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

December 3, 2024

Last Update Submit

January 24, 2025

Conditions

Fetal Ovarian Cyst

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Postnatal Outcomes

    Up to 100 weeks

  • Changes in the ultrasonographic features of the cyst in the prenatal period

    up to 100 weeks

  • Type of cyst on histologic examination in case of surgery

    Up to 100 weeks

  • Mode and type of surgery

    Up to 100 weeks

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Neonatal ovarian cyst

Study Officials

  • Elisa Montaguti, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 28, 2025

Study Start

May 29, 2023

Primary Completion

July 29, 2023

Study Completion

July 29, 2023

Last Updated

January 28, 2025

Record last verified: 2024-10

Locations

IT(1)