Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Ovarian Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222066
• Other study ID #: OV-UTERO 2000
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: February 2, 2010
• Start date: June 2001
• Est. completion date: September 2007

Study information

• Verified date: September 2006
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cysts
• Ovarian Cyst
• Ovarian Cysts
• Ultrasonography Prenatal

Intervention

Procedure:
• Fetal ovarian cyst aspiration
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia

Locations

Country	Name	City	State
France	CHU de Caen	Caen
France	CHU de Nantes	Nantes	Loire Atl
France	Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Tours	Centre

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To avoid neonatal surgery		3 months after birth	No
Secondary	Ultrasound pattern of neonatal ovarian cyst		3 months after birth	No
Secondary	Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration		3 months after birth	Yes