Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Not Applicable

Completed

• Conditions: Ovarian Cyst; Ultrasonography Prenatal

• 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

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Status Verified: 2006-09
• Primary Completion: 2007-01
• Study Completion: 2007-09
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

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

Primary Outcome Measures

Name	Time	Method
To avoid neonatal surgery	3 months after birth

Secondary Outcome Measures

Name	Time	Method
Ultrasound pattern of neonatal ovarian cyst	3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration	3 months after birth

Trial Locations

Locations (3)

Olympe de Gouges Women Health Centre, Bretonneau University Hospital; 🇫🇷 Tours, Centre, France

CHU de Nantes; 🇫🇷 Nantes, Loire Atl, France

CHU de Caen; 🇫🇷 Caen, France