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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007208
Receipt No. R000008486
Scientific Title Trials of fetoscopic laser surgery for twin twin transfusion during 26 to 27 weeks of gestation
Date of disclosure of the study information 2012/02/10
Last modified on 2017/04/20

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Basic information
Public title Trials of fetoscopic laser surgery for twin twin transfusion during 26 to 27 weeks of gestation
Acronym Fetoscopic laser surgery for TTTS at 26 and 27 weeks
Scientific Title Trials of fetoscopic laser surgery for twin twin transfusion during 26 to 27 weeks of gestation
Scientific Title:Acronym 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
1st name
Middle name
Last name Haruhiko Sago MD PhD
Organization National Center for Child Health and Development
Division name Department of Maternal-Fetal and Neonatal Medicine
Zip code
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
1st name
Middle name
Last name Masahiko Nakata MD PhD
Organization Kawasaki Medical School
Division name Department of Obstetrics and Gynecology2
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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