UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055338 |
|---|---|
| Receipt number | R000063211 |
| Scientific Title | Efficacy and Safety of Fetal Spinal Cord Meningocele Surgery |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2025/04/28 11:29:31 |
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Basic information
Public title
Promoting Clinical Application of Fetal Myelomeningocele Surgery through Advanced Medical Treatment
Acronym
Advanced Medical Treatment of Fetal Myelomeningocele Surgery
Scientific Title
Efficacy and Safety of Fetal Spinal Cord Meningocele Surgery
Scientific Title:Acronym
J-FOMS
Region
| Japan |
Condition
Condition
Myelomeningocele
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Meningocele(MMC) is a congenital malformation of the spinal cord that exposes the spinal cord to the outside world, and occurs frequently. Until recently, the standard of care has been to perform MMC ( neonatal surgery), in which the MMC is covered with skin or other tissue on the first day or two after birth. Recent studies have shown that if MMC closure surgery, which is conventionally performed in the neonatal period, is performed in the second trimester of pregnancy (fetal spinal meningocele surgery: closure of the fetal meningocele via maternal laparotomy and uterine incision, followed by return of the fetus into the uterus for full-term delivery) and the stimulation of the meningocele by amniotic fluid is interrupted early, the extent of spinal nerve damage can be reduced and the nerve prognosis improved and improve the neurological prognosis. Fetal MMC surgery has already shown efficacy in a prospective randomized controlled trial compared to neonatal MMC surgery, and has become one of the treatment options overseas. The purpose of this study was to gather more information on the efficacy and safety of fetal MMC closure in mid-pregnancy (fetal MMC surgery) for MMC, which is performed overseas, with the aim of obtaining future insurance coverage in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of hindbrain herniation at 12 months after birth
Key secondary outcomes
1, Efficacy endpoints
(1) Intraventriculo-abdominal shunt at 12 months of age
(2) Infant mortality up to 12 months after birth
(3) Completion of surgery
Safety endpoints
(1) Maternal adverse events
(2) Fetal/infant adverse events
Other endpoints
(1) Maternal endpoints
Preterm delivery within 4 weeks after surgery
Weeks of gestation at delivery
(2) Fetal/infant endpoints
Chiari malformation length of the hypoplasia
Presence of hydrocephalus
Presence/absence of lower extremity deformity
Lower extremity motor function
(3) Laboratory tests (blood and urine tests)
Hematological tests (WBC, RBC, Hb, Ht, Plt, WBC fraction)
Biochemical tests (AST, ALT, TP, CRP, creatinine)
Urinalysis (protein qualitative, sugar qualitative)
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
| 18 | 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 18 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
10
Research contact person
Name of lead principal investigator
| 1st name | MASAYUKI |
| Middle name | |
| Last name | ENDO |
Organization
THE UNIVERSITY OF OSAKA
Division name
Division of Medicine, Obstetrics and Gynecology
Zip code
565-0871
Address
Yamada-oka 2-2, Suita, Osaka
TEL
81668793351
endo@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | MASAYUKI |
| Middle name | |
| Last name | ENDO |
Organization
THE UNIVERSITY OF OSAKA
Division name
Division of Medicine, Obstetrics and Gynecology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita, Osaka
TEL
816068793351
Homepage URL
endo@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of OSAKA
Institute
Department
Personal name
MASAYUKI ENDO
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
Yamadaoka 2-2, Suita, Osaka
Tel
0662108296
rinri@hp-crc.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
大阪大学医学部附属病院（大阪府）、国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 26 | 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
| 2024 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2024 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063211
