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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Pregnancy | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |