UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030997 |
|---|---|
| Receipt number | R000035387 |
| Scientific Title | The natural history and risk factors of low back and pelvic pain for 12 months after child delivery in Japanese postpartum women |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2019/01/26 17:34:43 |
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Basic information
Public title
The natural history and risk factors of low back and pelvic pain for 12 months after child delivery in Japanese postpartum women
Acronym
The natural history and risk factors of low back and pelvic pain for 12 months after child delivery in Japanese postpartum women
Scientific Title
The natural history and risk factors of low back and pelvic pain for 12 months after child delivery in Japanese postpartum women
Scientific Title:Acronym
The natural history and risk factors of low back and pelvic pain for 12 months after child delivery in Japanese postpartum women
Region
| Japan |
Condition
Condition
pregnant and postpartum women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the natural course and risk factors of low back and pelvic pain for the 12 months after delivery.
Basic objectives2
Others
Basic objectives -Others
to identify risk factors of stained low back pain and pelvic pain for the 12 months after child delivery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain condition VAS(visual analog scale)
PGQ
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
having unmedicated vaginal delivery
healthiness of the child and mother who could start to care her new baby from the next day after the delivery
Key exclusion criteria
caesarean section
health problems excepting pelvic girdle pain difficulty in daily living
communication disorders
mental and physical disabilities
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyohi Gamada |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
Address
555-36 kurosegakuendai higashihiroshima hiroshima Japan
TEL
0823-70-4510
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Sakamoto |
Organization
Seirei Christopher University
Division name
Department of physical therapy, school of rehabilitation sciences
Zip code
Address
3453 mikatahara kita-ku hamamatsu shizuoka
TEL
053534391998
Homepage URL
asuka-s@seirei.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 05 | Month | 12 | Day |
Other
Other related information
longitudinalstudy
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035387
