Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

This study is currently recruiting participants.

Verified by University Hospital, Tours, June 2005

First Received: September 19, 2005 Last Updated: February 2, 2006 History of Changes

Sponsor:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00222066

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	Phase
Ovarian Cyst Ultrasonography Prenatal	Procedure: Fetal ovarian cyst aspiration	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Ovarian Cysts Prenatal Care Ultrasound

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:

To avoid neonatal surgery

Secondary Outcome Measures:

Ultrasound pattern of neonatal ovarian cyst
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration

Estimated Enrollment:	60
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2006

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 uneventfull 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222066

Contacts

Contact: Franck Perrotin, MD-PhD

+33 2 47 47 47 39

franck.perrotin@med.univ-tours.fr

Locations

France
CHU de Caen	Recruiting
Caen, France
Contact: Michel Herlicoviez, MD-PhD
France, Centre
Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Recruiting
Tours, Centre, France, 37044
Contact: Franck Perrotin, MD-PhD +33 2 47 47 47 39 franck.perrotin@med.univ-tours.fr
Principal Investigator: Franck Perrotin, MD-PhD
France, Loire Atl
CHU de Nantes	Recruiting
Nantes, Loire Atl, France, 44000
Contact: Norbert Winer, MD +33 (2) 40 08 31 90 norbert.winer@chu-nantes.fr
Principal Investigator: Norbert Winer, MD

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

Franck Perrotin, MD--PhD

Tours University Hospital

More Information

Publications:

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. Review.

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.

Study ID Numbers:	OV-UTERO 2000
Study First Received:	September 19, 2005
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00222066 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Tours:

Aspiration
Fetal ovarian cyst
Ovarian torsion

Additional relevant MeSH terms:

Genital Diseases, Female
Pathological Conditions, Anatomical
Neoplasms
Gonadal Disorders
Endocrine System Diseases

Ovarian Diseases
Cysts
Ovarian Cysts
Adnexal Diseases

ClinicalTrials.gov processed this record on November 27, 2009