Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Ovarian Cyst Ultrasonography Prenatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Fetal ovarian cyst aspiration performed as soon as possible

Group Type EXPERIMENTAL

Fetal ovarian cyst aspiration

Intervention Type PROCEDURE

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

2

Expectative

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fetal ovarian cyst aspiration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No