Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion | NCT00222066

Studies
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

NCT00222066

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Feb 3, 2010Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Ovarian Cyst
Ultrasonography Prenatal

Interventions

Fetal ovarian cyst aspiration

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Jan 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 19, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2010

Last Update Posted Date

Feb 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fetal ovarian cyst aspiration performed as soon as possible	Procedure: Fetal ovarian cyst aspiration
2	No Intervention	Expectative

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal ovarian cyst aspiration	Procedure	Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To avoid neonatal surgery		3 months after birth

Secondary Outcomes

Measure	Description	Time Frame
Ultrasound pattern of neonatal ovarian cyst		3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration		3 months after birth

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franck Perrotin, MD--PhD	Tours University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olympe de Gouges Women Health Centre, Bretonneau University Hospital		Tours	Centre-Val de Loire	37044	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11169374	Background	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.
10790628	Background	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.

ID	Term
D010048	Ovarian Cysts
C536396	Neonatal ovarian cyst
D000082843	Ovarian Torsion

ID	Term
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases