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Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00222066
First received: September 19, 2005
Last updated: February 2, 2010
Last verified: September 2006
  Purpose

The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.


Condition Intervention
Ovarian Cyst
Ultrasonography Prenatal
Procedure: Fetal ovarian cyst aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • To avoid neonatal surgery [ Time Frame: 3 months after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ultrasound pattern of neonatal ovarian cyst [ Time Frame: 3 months after birth ] [ Designated as safety issue: No ]
  • Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration [ Time Frame: 3 months after birth ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: June 2001
Study Completion Date: September 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier: NCT00222066     History of Changes
Other Study ID Numbers: OV-UTERO 2000
Study First Received: September 19, 2005
Last Updated: February 2, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Tours:
Aspiration
Fetal ovarian cyst
Ovarian torsion

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

ClinicalTrials.gov processed this record on July 29, 2014