UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019819 |
|---|---|
| Receipt number | R000022883 |
| Scientific Title | Babies' outcome of mothers with overt Hyper-/Hypo-thyroidism |
| Date of disclosure of the study information | 2015/11/19 |
| Last modified on | 2023/11/28 12:14:22 |
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Basic information
Public title
Babies' outcome of mothers with overt Hyper-/Hypo-thyroidism
Acronym
BOMOH2T
Scientific Title
Babies' outcome of mothers with overt Hyper-/Hypo-thyroidism
Scientific Title:Acronym
BOMOH2T
Region
| Japan |
Condition
Condition
Grave's disease,
autonomously functioning thyroid nodules,
hypothyroidism by TSH-receptor blocking antibodies
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify factors related to thyroid dysfunction of babies who were born from mothers with Graves' disease or with autonomously functioning thyroid nodule or with hypothyroidism by TSH-receptor blocking antibodies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preterm,
Low birth weight or macrosomia,
Fetal thyroid dysfunction,
Neonatal thyroid dysfunction,
Neuropsychological development at 1,3,6 years of age
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women with Graves' disease (untreated, oral medicine, post radioactive iodine therapy, post operation, remission),
Pregnant women with autonomously functioning thyroid nodules,
Pregnant women with hypothyroidism by TSH-receptor blocking antibodies
Key exclusion criteria
1)planning to delivery at other institutions
2)primary outcome'Neuropsychological development'only:
born from mothers with Graves' diasese keeping remission,
multiple malformation,
chromosomal abnormality,
born before 34 completed weeks of gestation
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiori Sato |
Organization
National Center for Child Health and Development, Tokyo, Japan
Division name
Maternal Medicine
Zip code
Address
10-1,Okura,2 chome,Setagaya,Tokyo,157-8535,JAPAN
TEL
03-3416-0181
boseinaika@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiori Sato |
Organization
National Center for Child Health and Development, Tokyo, Japan
Division name
Maternal Medicine
Zip code
Address
10-1,Okura,2 chome,Setagaya,Tokyo,157-8535,JAPAN
TEL
03-3416-0181
Homepage URL
boseinaika@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development, Tokyo, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design;Prospective cohort study
Subjects;Pregnant women with Graves' disease or with autonomously functioning thyroid nodules or with hypothyroidism by TSH-receptor blocking antibodies who are managed at this research facilities
The duration of the registration;from November 19, 2015 to December 31, 2027
This study is comprised of two stages.
The methods of first stage;To investigate perinatal complications and babies' (fetal and neonatal) thyroid dysfunction until one month after delivery
The methods of second stage;To investigate the growth and neuropsychological development of children who were born from mothers, who participated in the first stage, during periods from one month after birth to 6 years old
Management information
Registered date
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022883
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
