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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.
ClinicalTrials.gov Identifier: NCT00222066
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 3, 2010
Sponsor:
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
Ovarian Cyst Ultrasonography Prenatal Procedure: Fetal ovarian cyst aspiration

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 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
Primary Completion Date : January 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts
U.S. FDA Resources

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
Expectative



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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00222066


Locations
France
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
Investigators
Principal Investigator: Franck Perrotin, MD--PhD Tours University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier: NCT00222066     History of Changes
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:
Aspiration
Fetal ovarian cyst
Ovarian torsion

Additional relevant MeSH terms:
Cysts
Ovarian Cysts
Torsion Abnormality
Neoplasms
Pathological Conditions, Anatomical
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases