Unique ID issued by UMIN | UMIN000040088 |
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Receipt number | 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 | 2024/03/13 13:33:20 |
Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele
Japan |
Myelomeningocele
Obstetrics and Gynecology | Pediatrics | Neurosurgery |
Others
NO
The purpose of this study is to confirm the feasibility of fetal MMC surgery in Japan.
Safety
Confirmatory
Hindbrain herniation at the age of 12 months
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
MMC(Myelomeningocele) open fetal surgery
20 | years-old | <= |
Not applicable |
Female
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
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
15
1st name | MASAYUKI |
Middle name | |
Last name | ENDO |
Osaka University
Division of Medicine, Obstetrics and Gynecology
565-0871
2-2 Yamada-oka, Suita, Osaka
81668793351
mendoh@sahs.med.osaka-u.ac.jp
1st name | MASAYUKI |
Middle name | |
Last name | ENDO |
Osaka University
Division of Medicine, Obstetrics and Gynecology
565-0871
2-2 Yamada-oka, Suita, Osaka
81668793351
mendoh@sahs.med.osaka-u.ac.jp
OSAKA University
Department of Medicine
Division of Obstetrics and Gynecology
Osaka University
Self funding
National Center for Child Health and Development
Japan Agency for Medical Research and development, AMED (Practical Research Project for Rare/Intractable Diseases)
Osaka University
2-2 Yamada-oka, Suita, Osaka
+81 6 6210 8290
mendoh@sahs.med.osaka-u.ac.jp
NO
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)
2020 | Year | 04 | Month | 07 | Day |
Unpublished
Open public recruiting
2018 | Year | 12 | Month | 26 | Day |
2019 | Year | 07 | Month | 01 | Day |
2021 | Year | 04 | Month | 13 | Day |
2026 | Year | 09 | Month | 30 | Day |
2020 | Year | 04 | Month | 07 | Day |
2024 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040383
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