Clinical trial of thoracoamniotic shunting for fetal pleural effusion

UMIN ID: UMIN000001095

Registered date:28/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Fetal pleural effusion
• Date of first enrollment: 2008/04/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A shunt catheter (double bascket) is placed percutaneously between the fetal thorax and the amniotic fluid space under ultrasound guidance. For bilateral pleural effusions, shunt catheters are placed in both sides. In case of failure or reaccumulation of effusion, two more attempts are allowed to place the catheter in each side.

Outcome(s)

• Primary Outcome: Infant survival over 28 days of age
• Secondary Outcome: Reversal of hydrops, adverse events, complications of shunting

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 45years-old
• Gender: Female
• Exclude criteria: 1) Following ultrasound findings of the fetus detected within four days a. Anomaly except bronchopulmonary sequestration, cleft lip and palate, minor anomaly of fingers b. Tachycardia more than 200 bpm c. Bradycardia below 60 bpm d. Brain calcification e. Fetal anemia suspected by increased peak flow velocity of middle cerebral artery 2) Prior treatment for fetal pleural effusion except thoracocentesis 3) Positive indirect Coombs test 4) Chromosomal abnormality except Down syndrome 5) Mirror syndrome 6) Pregnancy induced hypertension 7) Genital bleeding 8) Short cervical length (<10mm)

Related Information

• Primary Sponsor: Japan Fetal Therapy Group (Fetusjapan)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare