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Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Not Applicable
Completed
Conditions
Ovarian Cyst
Ultrasonography Prenatal
Interventions
Procedure: Fetal ovarian cyst aspiration
Registration Number
NCT00222066
Lead Sponsor
University Hospital, Tours
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
61
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Fetal ovarian cyst aspirationFetal ovarian cyst aspiration performed as soon as possible
Primary Outcome Measures
NameTimeMethod
To avoid neonatal surgery3 months after birth
Secondary Outcome Measures
NameTimeMethod
Ultrasound pattern of neonatal ovarian cyst3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration3 months after birth

Trial Locations

Locations (3)

CHU de Nantes

🇫🇷

Nantes, Loire Atl, France

CHU de Caen

🇫🇷

Caen, France

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

🇫🇷

Tours, Centre, France

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