Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Ultrasonography Prenatal; Ovarian Cyst

Treatments: Procedure: Fetal ovarian cyst aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT00222066

OV-UTERO 2000

Details and patient eligibility

About

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

Full 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

Enrollment: 61 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

1

Experimental group

Description:

Fetal ovarian cyst aspiration performed as soon as possible

Treatment:

Procedure: Fetal ovarian cyst aspiration

2

No Intervention group

Description:

Expectative