UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032241 |
|---|---|
| Receipt number | R000036731 |
| Scientific Title | Evaluation of home visiting by midwifes to women with threatened preterm labor after leaving a hospital |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2018/04/13 15:51:06 |
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Basic information
Public title
Evaluation of home visiting by midwifes to women with threatened preterm labor after leaving a hospital
Acronym
Evaluation of home visiting by midwifes to women with TPL after leaving a hospital
Scientific Title
Evaluation of home visiting by midwifes to women with threatened preterm labor after leaving a hospital
Scientific Title:Acronym
Evaluation of home visiting by midwifes to women with TPL after leaving a hospital
Region
| Japan |
Condition
Condition
threatened premature labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a home visiting by midwives to women with threatened preterm labor before 37 weeks after leaving a hospital
Basic objectives2
Others
Basic objectives -Others
To evaluate the contents of the visiting manual
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The feasibility of a home visiting by midwives to women with threatened preterm labor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
home visiting by midwives
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women with threatened preterm labor who are in the hospital from 34 weeks to less than 37 weeks, but are scheduled to be discharged
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yaeko Kataoka |
Organization
St.Luke's International University
Division name
College of Nursing
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, JAPAN
TEL
03-3543-6391
yaeko-kataoka@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yaeko Kataoka |
Organization
St.Luke's International University
Division name
College of Nursing
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, JAPAN
TEL
03-3543-6391
Homepage URL
yaeko-kataoka@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Kanhoren
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
| 2018 | Year | 04 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036731
