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Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00222066
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 3, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cyst Ultrasonography Prenatal Procedure: Fetal ovarian cyst aspiration Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
Study Start Date : June 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
Experimental: 1
Fetal ovarian cyst aspiration performed as soon as possible
Procedure: Fetal ovarian cyst aspiration
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia

No Intervention: 2

Primary Outcome Measures :
  1. To avoid neonatal surgery [ Time Frame: 3 months after birth ]

Secondary Outcome Measures :
  1. Ultrasound pattern of neonatal ovarian cyst [ Time Frame: 3 months after birth ]
  2. Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration [ Time Frame: 3 months after birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00222066

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Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, Centre, France, 37044
CHU de Nantes
Nantes, Loire Atl, France, 44000
CHU de Caen
Caen, France
Sponsors and Collaborators
University Hospital, Tours
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Principal Investigator: Franck Perrotin, MD--PhD Tours University Hospital
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Responsible Party: Pr Franck Perrotin, CHRU de Tours Identifier: NCT00222066    
Other Study ID Numbers: OV-UTERO 2000
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: September 2006
Keywords provided by University Hospital, Tours:
Fetal ovarian cyst
Ovarian torsion
Additional relevant MeSH terms:
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Ovarian Cysts
Pathological Conditions, Anatomical
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases