UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004165
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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 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
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)

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.