UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030530 |
|---|---|
| Receipt number | R000034854 |
| Scientific Title | Text messaging for maternal health |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/06/25 09:39:07 |
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Basic information
Public title
Text messaging for maternal health
Acronym
Text messaging for maternal health
Scientific Title
Text messaging for maternal health
Scientific Title:Acronym
Text messaging for maternal health
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to evaluate the effects of text messaging intervention to improve mental health of pregnant woman
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State-Trait Anxiety Inventory
Key secondary outcomes
Birth weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Providing information about pregnancy via text messaging(6 months)
Interventions/Control_2
Providing information about childcare via text messaging(4 months)
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Primigravid woman
Have normal health
Key exclusion criteria
Have any disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toyohiko |
| Middle name | |
| Last name | KODAMA |
Organization
University of Occupational and Environmental Health, Japan
Division name
School of Health Sciences
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL
093-603-1611
t-kodama@health.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyohiko |
| Middle name | |
| Last name | KODAMA |
Organization
University of Occupational and Environmental Health, Japan
Division name
School of Health Sciences
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL
093-603-1611
Homepage URL
t-kodama@health.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan
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
University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
Tel
059-231-5246
daigakukanri@mbox.pub.uoeh-u.ac.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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
40
Results
No significant difference between group characteristics was noted at baseline. The percentage of cesarean births in the intervention group was significantly lower. Additionally, in the intervention group, the average value for the response "I have been stretching" was significantly high, and the average value for the response "regular bowel movements" was significantly low. Most participants reported that the intervention was at least somewhat useful.
Results date posted
| 2020 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Primigravid woman
Have normal health
Participant flow
Text messages were sent twice weekly to the intervention group from week 13 of pregnancy until childbirth.
Adverse events
None
Outcome measures
State-Trait Anxiety Inventory
Birth weight
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | 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
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034854
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
