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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040088
Receipt No. R000040383
Scientific Title Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/07

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Basic information
Public title Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Acronym Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Scientific Title Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Scientific Title:Acronym Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Region
Japan

Condition
Condition Myelomeningocele
Classification by specialty
Obsterics and gynecology Pediatrics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to confirm the feasibility of fetal MMC surgery in Japan.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hindbrain herniation at the age of 12 months
Key secondary outcomes the need for placement of a cerebrospinal fluid shunt by the age of 12 months
Accomplishments of the fetal surgery
Maternal Adverse Events
Fetal Adverse Events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 MMC(Myelomeningocele) open fetal 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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Myelomeningocele at level T1 through S1
With evidence of hindbrain herniation
at least 20 years old of maternal age
19+0 to 25+6 weeks of gestational age
Singleton pregnancy
Key exclusion criteria Additional fetal anomalies not related with MMC
HIV or Hepatitis B/C positive
Increased risk for preterm delivery:
short cervix,
cervical incompetency,
uterine anomaly,
previa,
prior spontaneous preterm delivery
Multifetal pregnancy
Previous hysterotomy
Prior abruptio placentae
Kyphosis in the fetus of 30 degrees or more
Insulin dependent pregestational diabetes
Rh isoimmunization
Body mass index > 35
Patient does not have a support person.
Psychosocial issues preventing compliance
Other contraindications to elective surgery
Target sample size 15

Research contact person
Name of lead principal investigator
1st name MASAYUKI
Middle name
Last name ENDO
Organization Osaka University
Division name Division of Medicine, Obstetrics and Gynecology
Zip code 565-0871
Address 2-2 Yamada-oka, Suita, Osaka
TEL 81668793351
Email mendoh@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name MASAYUKI
Middle name
Last name ENDO
Organization Osaka University
Division name Division of Medicine, Obstetrics and Gynecology
Zip code 565-0871
Address 2-2 Yamada-oka, Suita, Osaka
TEL 81668793351
Homepage URL
Email mendoh@sahs.med.osaka-u.ac.jp

Sponsor
Institute OSAKA University

Department of Medicine
Division of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University
Address 2-2 Yamada-oka, Suita, Osaka
Tel +81 6 6210 8290
Email mendoh@sahs.med.osaka-u.ac.jp

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
2020 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 26 Day
Date of IRB
2019 Year 07 Month 01 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 07 Day
Last modified on
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040383

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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