UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017680 |
|---|---|
| Receipt number | R000020403 |
| Scientific Title | Impact of physical activity on perinatal complications |
| Date of disclosure of the study information | 2015/05/30 |
| Last modified on | 2019/09/04 10:07:48 |
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Basic information
Public title
Impact of physical activity on perinatal complications
Acronym
Impact of physical activity on perinatal complications
Scientific Title
Impact of physical activity on perinatal complications
Scientific Title:Acronym
Impact of physical activity on perinatal complications
Region
| Japan |
Condition
Condition
Pregnant Women
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of physical activity on prevention of prenatal complications such as gestational diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of gestational diabetes mellitus
Key secondary outcomes
Incidence of difficult parturition
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
Adult pregnant women who agree to participate in the study and answer a questionnaire.
Key exclusion criteria
Subjects who do not agree to participate in the study answer a questionnaire.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Matsumoto |
Organization
Keio University
Division name
Institute for Integrated Sports Medicine, School of Medicine
Zip code
Address
Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
m-hideo@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Tabata |
Organization
Keio University
Division name
Institute for Integrated Sports Medicine, School of Medicine
Zip code
Address
Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
sky_walker_590718@yahoo.co.jp
Sponsor or person
Institute
Shogo Tabata
Institute
Department
Personal name
Funding Source
Organization
Institute for Integrated Sports Medicine, School of Medicine, Keio University
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
Address
Tel
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 | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we will carry out a questionnaire about physical activity 3 times in first and third trimester and puerperal period.
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020403
