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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017665
Receipt No. R000020473
Scientific Title Effects of socioeconomic status on maternal lifestyle patterns and birth outcomes: An observational single center study
Date of disclosure of the study information 2015/05/25
Last modified on 2019/03/14

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Basic information
Public title Effects of socioeconomic status on maternal lifestyle patterns and birth outcomes: An observational single center study
Acronym Effects of socioeconomic status on maternal lifestyle patterns and birth outcomes: An observational single center study
Scientific Title Effects of socioeconomic status on maternal lifestyle patterns and birth outcomes: An observational single center study
Scientific Title:Acronym Effects of socioeconomic status on maternal lifestyle patterns and birth outcomes: An observational single center study
Region
Japan

Condition
Condition Pregnancy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effects of socioeconomic status on maternal dietary food intake, lifestyle patterns, and birth outcome
Basic objectives2 Others
Basic objectives -Others To investigate the effects of socioeconomic status on maternal dietary food intake, lifestyle patterns, and birth outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Birth outcome: Low birh weight ( < 2,500 g )
Key secondary outcomes Maternal:
1) Pregnancy induced hypertention (PIH)
2) Gestational diabetes mellitus (GDM)
Birth outcome:
3) Small for gestational age (SGA)
4) Pre-term birth (before 37 weeks gestation)
5) Stillbirth (after 22 weeks gestation)
6) Gestational age
Neonatal:
7) DNA methylation (umbilical cord blood)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Pregnant women
2) Received prenatal care before 16 weeks gestation
3) More than 20 years old when informed consent was given
4) Receive their entire prenatal care and delivery at our Center
5) Permission to participate in this study by their obstetricians
6) Written informed consent
Key exclusion criteria 1) Inability to read/write Japanese
2) Limited prenatal care before delivery at our Center
3) Women judged by their obstetricians to be ineligible
4) Women with other reasons that would prevent protocol completion
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Abiko
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Obstetrics and Gynecology
Zip code 6128555
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL +81-75-641-9161
Email abiko.kaoru.hf@mail.hosp.go.jp

Public contact
Name of contact person
1st name Ikuyo
Middle name
Last name Hayashi
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Preventive Medicine, Clinical Research Institute
Zip code 6128555
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL +81-75-641-9161
Homepage URL
Email suganuma.akiko.wh@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center (Kyoto, Japan)
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of National Hospital Organization Kyoto Medical Center
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
Tel +81-75-641-9161
Email naoki.sakane.zn@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 25 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 04 Month 20 Day
Date of IRB
2015 Year 04 Month 20 Day
Anticipated trial start date
2015 Year 05 Month 26 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2015 Year 05 Month 25 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020473

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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