NIPH Clinical Trials Search

UMIN ID: UMIN000001095

Registered date:28/03/2008

Clinical trial of thoracoamniotic shunting for fetal pleural effusion

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedFetal pleural effusion
Date of first enrollment2008/04/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeInfant survival over 28 days of age
Secondary OutcomeReversal of hydrops, adverse events, complications of shunting

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum45years-old
Include criteria
Exclude criteria1) 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


public contact
Address Japan
Telephone 03-5297-6258
Affiliation Japan Clinical Research Support Unit Department of Pediatric Research
scientific contact
Name Haruhiko Sago MD PhD
Address 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan Japan
Telephone 03-3416-0181
Affiliation National Center for Child Health and Development Department of Perinatal Medicine and Maternal Care