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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007000
Receipt No. R000008260
Scientific Title Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction
Date of disclosure of the study information 2012/01/01
Last modified on 2015/01/01

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Basic information
Public title Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction
Acronym Fetoscopic laser surgery for SIUGR
Scientific Title Trials of fetoscopic laser surgery for Monochorionic twin pregnancy with severe selective intarauterine growth restriction
Scientific Title:Acronym Fetoscopic laser surgery for SIUGR
Region
Japan

Condition
Condition Monochorionic twin pregnancy with severe selective intarauterine growth restriction; SIUGR
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 severe selective intarauterine growth restriction.
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 safety for pregnant women
Key secondary outcomes Improvement of SIUGR at 14 days after surgery, incidence of TTTS or 14 days after surgery, Complications of laser surgery until 14 days 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
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 20 weeks and 24 weeks gestation
2) Monochorionic diamniotic twin pregnancy
3) Ultrasound findings within four days before surgery meet the criteria as described following
I) Estimated fetal weight is less than -1.5SD in one twin
II) not TTTS (MVP>2cm in one twin, and MVP<8cm in another twin and not TAFD(MVP<3cm in one twin and MVP>7cm in another twin)
III) The presence of severe oligohydramnios defined by less than 1cm of MVP in a smaller twin
IV) Presence of abnormal Doppler study in a smaller 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) Greater than or equal to 20mm of Cervical length
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 813334160181
Email sagou-h@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Ishii MD Ph D
Organization Osaka Medical Center and Research Institute for Maternal and Child Health
Division name Department of Maternal-Fetal Medicine
Zip code
Address 840 Murodo, Izumi, Osaka, 5941101, Japan
TEL 81725561220
Homepage URL
Email keisui@mch.pref.osaka.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
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 01 Month 01 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
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 01 Day
Last modified on
2015 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008260

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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