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OpenTrials
Completed

NCT Number: NCT06795685

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

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Postnatal Outcomes

    Time frame: Up to 100 weeks

    Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

  2. Changes in the ultrasonographic features of the cyst in the prenatal period

    Time frame: up to 100 weeks

    Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

  3. Type of cyst on histologic examination in case of surgery

    Time frame: Up to 100 weeks

    • mode and type of surgery

    Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

  4. Mode and type of surgery

    Time frame: Up to 100 weeks

    Description of the cohort of fetuses prenatally diagnosed with suspected ovarian cyst

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: OVARY22

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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