Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion - Tabular View

Tracking Information

First Received Date ^ICMJE

September 19, 2005

Last Updated Date

February 2, 2006

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To avoid neonatal surgery

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00222066 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ovarian Cyst
Ultrasonography Prenatal

Intervention ^ICMJE

Procedure: Fetal ovarian cyst aspiration

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Franck Perrotin, MD-PhD

+33 2 47 47 47 39

franck.perrotin@med.univ-tours.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00222066

Responsible Party

Study ID Numbers ^ICMJE

OV-UTERO 2000

Study Sponsor ^ICMJE

University Hospital, Tours

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Franck Perrotin, MD--PhD

Tours University Hospital

Information Provided By

University Hospital, Tours

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP