Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion - Full Text View

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
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:

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 [ 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

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:

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.

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 February 13, 2012