UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial of fetoscopic laser surgery for twin amniotic fluid discordance
Title of the study (Brief title)	Fetoscopic laser surgery for TAFD
Region	Japan

Condition
Condition	Twin Amniotic Fluid Discordance; TAFD
Classification by specialty	Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of fetoscopic laser surgery for the monochorionic twin pregnancy with both the discordance of amniotic fluid between the twins and abnormal Doppler findings.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Completion of laser surgery and safety for pregnant women
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	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 abdomen. The lactolinger is infused into the amniotic cavity if necessary. The amniotic fluid is aspirated at the end of the surgery.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	45 years-old >
Gender	Female
Key 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
Key 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
Target sample size	10

Research contact person
Name of lead principal investigator	Haruhiko Sago MD PhD
Organization	National Center for Child Health and Development
Division name	Department of Maternal-Fetal and Neonatal Medicine
Address	2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL	03-3416-0181
Email	sagou-h@ncchd.go.jp

Public contact
Name of contact person	Haruhiko Sago MD PhD
Organization	National Center for Child Health and Development
Division name	Division of Fetal Medicine, Department of Maternal-Fetal and Neonatal Medicine
Address	2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL	03-3416-0181
Homepage URL
Email	sagou-h@ncchd.go.jp

Sponsor
Institute	Japan Fetal Therapy Group (Fetusjapan)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 05 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2014 Year 10 Month 06 Day
Date of closure to data entry	2014 Year 10 Month 06 Day
Date trial data considered complete	2014 Year 10 Month 14 Day
Date analysis concluded	2016 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	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%).
Other related information

Management information
Registered date	2010 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005002