UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032241
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email yaeko-kataoka@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.