Fetal pleural effusion
Conditions
Interventions
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
Sponsors
Japan Fetal Therapy Group (Fetusjapan)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Between 18 weeks and 33 weeks 6 days gestation 2) Singletone pregnancy 3) Massive unilateral/bilateral pleural effusion of the fetus detected ultrasound within four days 4) Reaccumulation of fetal pleural effusion after thoracocentesis in seven days 5) Written consents to the trial from the mother and her husband
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant survival over 28 days of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Reversal of hydrops, adverse events, complications of shunting | — |
Countries
Japan
Outcome results
None listed