UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007208 |
|---|---|
| Receipt number | 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 09:12:48 |
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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
| Obstetrics 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
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
nakata@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Japan Fetal Therapy Group (Fetus Japan)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008486
