UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trials of fetoscopic laser surgery for twin twin transfusion during 26 to 27 weeks of gestation
Title of the study (Brief title)	Fetoscopic laser surgery for TTTS at 26 and 27 weeks
Region	Japan

Condition
Condition	Twin twin transfusion syndrome
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 twin twin transfusion during 26 to 27 weeks of gestation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Completion of laser surgery and surgery for pregnant women
Key secondary outcomes	Improvement of TTTS at 14 days after surgery, Complications of laser surgery until 14 days 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	Device,equipment 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 26 and 27 weeks of gestation 2) Monochorionic diamniotic twin pregnancy 3) Ultrasound findings before surgery meet the criteria as described following i. TTTS (MVP > 10 cm in one twin, and MVP < 2 cm in another twin) ii. No presence of fetal anomaies 4) No sign of pregnancy induced hypertension 5) No genital bleeding 6) No premature rupture of membrane 7) Greater than or equal to 20 mm of cervical length
Key exclusion criteria	1) Pregnant woman needs treatment for infectious disease. 2) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women 3) Pregnant woman needs treatment for psychological problems 4) 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	Masahiko Nakata MD PhD
Organization	Kawasaki Medical School
Division name	Department of Obstetrics and Gynecology2
Address	2-1-80 Nakasange, Okayama-city
TEL	086-225-2111
Homepage URL
Email	nakata@med.kawasaki-m.ac.jp

Sponsor
Institute	Japan Fetal Therapy Group (Fetus Japan)
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	国立成育医療研究センター（東京都）、聖隷浜松病院（静岡県）、国立病院機構長良医療センター（岐阜県）、大阪府立母子保健総合医療センター（大阪府）、徳山中央病院（山口県）

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 14 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2013 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 03 Month 01 Day
Date analysis concluded	2014 Year 03 Month 01 Day

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

Management information
Registered date	2012 Year 02 Month 02 Day
Last modified on	2017 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008486