UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041966 |
|---|---|
| Receipt number | R000047900 |
| Scientific Title | Retrospective study about the effect of maternal periodontal disease on child's growth and development |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/05/09 15:22:30 |
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Basic information
Public title
Study on the effect of periodontal disease during pregnancy on child's growth
Acronym
Study on relationship between periodontal disease during pregnancy and child's growth
Scientific Title
Retrospective study about the effect of maternal periodontal disease on child's growth and development
Scientific Title:Acronym
Retrospective study on relationship between maternal periodontal disease and child's growth and development
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of maternal periodontal disease on child's growth.
Basic objectives2
Others
Basic objectives -Others
Evaluation of child's growth and development
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Child's weight and height
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
Male and Female
Key inclusion criteria
Participants of the research about the effect of maternal periodontitis on threatened preterm labor and low birth weight which was conducted from 2009 to 2011.
Key exclusion criteria
Not applicable
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Maternal and Women's clinic
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-5322
a-kacrm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Maternal and Women's clinic
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
TEL
03-5803-5322
Homepage URL
a-kacrm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Institution Ethics committee of Tokyo Medical and Dental University Medical School
Address
1-5-45 Yushima, Bunkyo-ku Tokyo
Tel
03-5803-5096
soumu1.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M2020-179
Org. issuing International ID_1
Institution Ethics committee of Tokyo Medical and Dental University Medical School
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 | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 01 | Day |
Other
Other related information
Investigation of maternal periodontal disease: using data from previous research about the effect of maternal periodontitis on threatened preterm labor and low birth weight.
Investigation of outcome: questionnaire about child's present weight and height, weight, height and head circumference at medical examination for 1 year and 6 months-old and 3-year-old.
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047900
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
