UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019419 |
|---|---|
| Receipt number | R000022463 |
| Scientific Title | Effects of socioeconomic status on maternal lifestyle, pregnant outcome and birth outcome: An observational single center study |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2019/03/14 13:48:07 |
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Basic information
Public title
Effects of socioeconomic status on maternal lifestyle, pregnant outcome and birth outcome: An observational single center study
Acronym
Effects of socioeconomic status on maternal lifestyle, pregnant outcome and birth outcome: An observational single center study
Scientific Title
Effects of socioeconomic status on maternal lifestyle, pregnant outcome and birth outcome: An observational single center study
Scientific Title:Acronym
Effects of socioeconomic status on maternal lifestyle, pregnant outcome and birth outcome: An observational single center study
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of socioeconomic status on maternal lifestyle patterns, pregnant outcome and birth outcome
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of socioeconomic status on maternal lifestyle patterns, pregnant outcome 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)
3) Hospital stay days
Birth outcome:
4) Small for gestational age (SGA)
5) Pre-term birth (before 37 weeks gestation)
6) Birth weight
7) Gestational age
Neonatal:
8) NICU use
9) 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) More than 20 years old when informed consent was given
3) Ability to read/write Japanese
4) Written informed consent
Key exclusion criteria
1) Limited prenatal care before delivery at our Center
2) Women judged by their obstetricians to be ineligible
3) 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
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
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
+81-75-641-9161
Homepage URL
suganuma.akiko.wh@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
独立行政法人国立病院機構 京都医療センター (京都府)
National Hospital Organization Kyoto Medical Center (Kyoto, Japan)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 20 | 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 | 10 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2020 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022463
| Research Plan | |
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| 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 |
