Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
1 other identifier
interventional
61
1 country
3
Brief Summary
The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2001
Longer than P75 for not_applicable
3 active sites
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
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 3, 2010
September 1, 2006
5.6 years
September 19, 2005
February 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To avoid neonatal surgery
3 months after birth
Secondary Outcomes (2)
Ultrasound pattern of neonatal ovarian cyst
3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration
3 months after birth
Study Arms (2)
1
EXPERIMENTALFetal ovarian cyst aspiration performed as soon as possible
2
NO INTERVENTIONExpectative
Interventions
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
Eligibility Criteria
You may qualify if:
- Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)
You may not qualify if:
- Multiple pregnancy
- Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
- Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
- Unability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, Centre-Val de Loire, 37044, France
CHU de Nantes
Nantes, Loire Atl, 44000, France
CHU de Caen
Caen, France
Related Publications (2)
Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. doi: 10.1046/j.1469-0705.2000.00247.x.
PMID: 11169374BACKGROUNDPerrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.
PMID: 10790628BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck Perrotin, MD--PhD
Tours University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
June 1, 2001
Primary Completion
January 1, 2007
Study Completion
September 1, 2007
Last Updated
February 3, 2010
Record last verified: 2006-09