Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restrictio

Phase 1

• Conditions: Monochorionic twin pregnancy with severe selective intarauterine growth restriction; SIUGR

• Registration Number: JPRN-UMIN000007000
• Lead Sponsor: Japan Fetal Therapy Group (Fetus Japan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-01
• Study Completion: 2014-12-31
• Last Update Posted: 17 October 2023

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

Name	Time	Method
Completion of laser surgery and safety for pregnant women

Secondary Outcome Measures

Name	Time	Method
Improvement of SIUGR at 14 days after surgery, incidence of TTTS or 14 days after surgery, Complications of laser surgery until 14 days after laser surgery