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Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Primary Purpose

Ovarian Cyst, Ultrasonography Prenatal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fetal ovarian cyst aspiration
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cyst focused on measuring Aspiration, Fetal ovarian cyst, Ovarian torsion

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Olympe de Gouges Women Health Centre, Bretonneau University Hospital
  • CHU de Nantes
  • CHU de Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Fetal ovarian cyst aspiration performed as soon as possible

Expectative

Outcomes

Primary Outcome Measures

To avoid neonatal surgery

Secondary Outcome Measures

Ultrasound pattern of neonatal ovarian cyst
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration

Full Information

First Posted
September 19, 2005
Last Updated
February 2, 2010
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT00222066
Brief Title
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
Official Title
Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst, Ultrasonography Prenatal
Keywords
Aspiration, Fetal ovarian cyst, Ovarian torsion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fetal ovarian cyst aspiration performed as soon as possible
Arm Title
2
Arm Type
No Intervention
Arm Description
Expectative
Intervention Type
Procedure
Intervention Name(s)
Fetal ovarian cyst aspiration
Intervention Description
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
Primary Outcome Measure Information:
Title
To avoid neonatal surgery
Time Frame
3 months after birth
Secondary Outcome Measure Information:
Title
Ultrasound pattern of neonatal ovarian cyst
Time Frame
3 months after birth
Title
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration
Time Frame
3 months after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Perrotin, MD--PhD
Organizational Affiliation
Tours University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
City
Tours
State/Province
Centre
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Nantes
City
Nantes
State/Province
Loire Atl
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11169374
Citation
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.
Results Reference
background
PubMed Identifier
10790628
Citation
Perrotin 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.
Results Reference
background

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Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

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