Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

N/ACompletedNCT00222066

University Hospital, Tours61 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cyst Ultrasonography Prenatal

Interventions

Fetal ovarian cyst aspirationPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Tours, Centre-Val de Loire, France

CHU de Nantes

Nantes, Loire Atl, France

CHU de Caen

Caen, France

Outcomes

Primary Outcomes

To avoid neonatal surgery

Time frame: 3 months after birth

Secondary Outcomes

Ultrasound pattern of neonatal ovarian cyst

Time frame: 3 months after birth

Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration

Time frame: 3 months after birth

Data from ClinicalTrials.gov

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