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Completed

NCT Number: NCT00222066

Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

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Key information

Conditions

Ovarian Cyst Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neonatal ovarian cyst Neoplasms Ovarian Cysts Ovarian Diseases Ovarian Torsion Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Torsion Abnormality Ultrasonography Prenatal Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Olympe de Gouges Women Health Centre, Bretonneau University Hospital, Tours, Centre-Val de Loire, France

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About this study

With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)

Exclusion criteria

  • Multiple pregnancy
  • Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
  • Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
  • Unability to give informed consent

Treatment and study plan

Fetal ovarian cyst aspiration

Procedure

Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia

Primary outcomes

  1. To avoid neonatal surgery

    Time frame: 3 months after birth

Secondary outcomes

  1. Ultrasound pattern of neonatal ovarian cyst

    Time frame: 3 months after birth

  2. Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration

    Time frame: 3 months after birth

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Feb 3, 2010

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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