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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041966
Receipt No. 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 2020/10/01

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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
Email 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
Email a-kacrm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 31 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

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
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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