UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004165 |
|---|---|
| Receipt number | R000005002 |
| Scientific Title | Trial of fetoscopic laser surgery for twin amniotic fluid discordance |
| Date of disclosure of the study information | 2010/09/09 |
| Last modified on | 2017/09/11 10:59:15 |
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Basic information
Public title
Trial of fetoscopic laser surgery for twin amniotic fluid discordance
Acronym
Fetoscopic laser surgery for TAFD
Scientific Title
Trial of fetoscopic laser surgery for twin amniotic fluid discordance
Scientific Title:Acronym
Fetoscopic laser surgery for TAFD
Region
| Japan |
Condition
Condition
Twin Amniotic Fluid Discordance; TAFD
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 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
| 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 | 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
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL
03-3416-0181
Homepage URL
sagou-h@ncchd.go.jp
Sponsor or person
Institute
Japan Fetal Therapy Group (Fetusjapan)
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 09 | 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
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%).
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
| 2010 | Year | 04 | Month | 05 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005002
