Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

February 2, 2010 updated by: University Hospital, Tours

Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • CHU de Caen
    • Centre
      • Tours, Centre, France, 37044
        • Olympe de Gouges Women Health Centre, Bretonneau University Hospital
    • Loire Atl
      • Nantes, Loire Atl, France, 44000
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To avoid neonatal surgery
Time Frame: 3 months after birth
3 months after birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Franck Perrotin, MD--PhD, Tours University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OV-UTERO 2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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