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

Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction - Fetoscopic laser surgery for SIUGR

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007000

Enrollment

Registered

2012-01-01

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monochorionic twin pregnancy with severe selective intarauterine growth restriction

Interventions

Fetsocopic laser surgery is performed according to the procedure for twin to twin transfusion syndrome. The anastomoses between the twins are coagulated by laser under fetoscopy through the maternal

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Between 20 weeks and 24 weeks gestation 2) Monochorionic diamniotic twin pregnancy 3) Ultrasound findings within four days before surgery meet the criteria as described following I) Estimated fetal weight is less than -1.5SD in one twin II) not TTTS (MVP>2cm in one twin, and MVP<8cm in another twin and not TAFD(MVP<3cm in one twin and MVP>7cm in another twin) III) The presence of severe oligohydramnios defined by less than 1cm of MVP in a smaller twin IV) Presence of abnormal Doppler study in a smaller twin 4) No history of amnioreduction 5) No presence of fetal anomalies 6) No sign of pregnancy induced hypertension 7) No genital bleeding 8) No premature rupture of membrane 9) Greater than or equal to 20mm of Cervical length

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Completion of laser surgery and safety for pregnant women	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKeisuke Ishii MD Ph D

Osaka Medical Center and Research Institute for Maternal and Child Health Department of Maternal-Fetal Medicine

keisui@mch.pref.osaka.jp81725561220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026