UMIN-CTR Clinical Trial

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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