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Trial of fetoscopic laser surgery for twin amniotic fluid discordance

Not Applicable
Conditions
Twin Amniotic Fluid Discordance
TAFD
Registration Number
JPRN-UMIN000004165
Lead Sponsor
Japan Fetal Therapy Group (Fetusjapan)
Brief Summary

A total of 11 cases were enrolled. FLP was completed in all cases. There were no severe FLP-related maternal complications. Among 11 donor twins, 3 survived, 7 died in utero, and 1 died in the neonatal period (survival rate: 27.3%). All of the recipient twins survived (survival rate: 100%).

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

1) Distance between expected insertion site of fetoscopy and the edge of placenta is below 1 cm. 2) Pregnant woman needs treatment for infectious disease. 3) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women 4) Pregnant woman needs treatment for psychological problems 5) American Society of Anesthesiology (ASA) Physical Status Classification: Class 3, 4, 5, or 6

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Completion of laser surgery and safety for pregnant women
Secondary Outcome Measures
NameTimeMethod
Improvement of TAFD at 14 days after surgery, incidence of TTTS at 14 days after surgery, Complications of laser surgery until 14days after laser surgery
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