Trial of fetoscopic laser surgery for twin amniotic fluid discordance

Trial of fetoscopic laser surgery for twin amniotic fluid discordance - Fetoscopic laser surgery for TAFD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004165

Enrollment

Registered

2010-09-09

Start date

2010-09-01

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

Twin Amniotic Fluid Discordance

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 6 days gestation 2) Monochorionic diamniotic twin pregnancy 3) Ultrasound findings within four days before surgery meet the criteria as following a) not TTTS (Maximal vertical pocket (MVP) between 2cm and 8cm) b) MVP blow 3cm in one twin, and MVP more than 7cm in the other twin c) Presence of abnormal Doppler study in either 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) Cervical length more than 20mm

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 TAFD at 14 days after surgery, incidence of TTTS at 14 days after surgery, Complications of laser surgery until 14days after laser surgery	—

Countries

Japan

Contacts

Public ContactHaruhiko Sago MD PhD

National Center for Child Health and Development Division of Fetal Medicine, Department of Maternal-Fetal and Neonatal Medicine

sagou-h@ncchd.go.jp03-3416-0181

Outcome results

None listed

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