UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040088
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

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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

Obstetrics 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 or person

Institute

OSAKA University

Department of Medicine
Division of Obstetrics and Gynecology

Institute

Department

Personal name



Funding Source

Organization

Osaka University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Center for Child Health and Development

Name of secondary funder(s)

Japan Agency for Medical Research and development, AMED (Practical Research Project for Rare/Intractable Diseases)


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

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

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

2021 Year 04 Month 13 Day

Last follow-up date

2026 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

2024 Year 03 Month 13 Day



Link to view the page

Value
https://center6.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