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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008074
Receipt No. R000009509
Scientific Title A study of stress in pregnancy and post-delivery.
Date of disclosure of the study information 2012/06/01
Last modified on 2020/04/29

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Basic information
Public title A study of stress in pregnancy and post-delivery.
Acronym Measurements of stress-related salivary substances and autonomic nervous tone in pregnancy and post-delivery.
Scientific Title A study of stress in pregnancy and post-delivery.
Scientific Title:Acronym Measurements of stress-related salivary substances and autonomic nervous tone in pregnancy and post-delivery.
Region
Japan

Condition
Condition Women in pregnancy and post-delivery
Classification by specialty
Obsterics and gynecology Pediatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measurements of stress-related substances and autonomic nervous tone in pregnancy and post-delivery.
Basic objectives2 Others
Basic objectives -Others Physiological changes
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Phase in pregnancy and post-delivery.
Key secondary outcomes The early-, middle-, and late-pregnancy and just, 1 month, 3-4 months and 1 year after delivery.

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women in pregnancy and post-delivery.
Key exclusion criteria Women with complicating disease in pregnancy and post-delivery.
Target sample size 78

Research contact person
Name of lead principal investigator
1st name Hiroe
Middle name
Last name Washio
Organization Kansai University of International Studies
Division name School of Health Sciences
Zip code 673-0521
Address 1-18 Aoyama, Shijimi-cho, Miki, Hyogo 673-0521 Japan
TEL 0794-84-3513
Email h-washio@kuins.ac.jp

Public contact
Name of contact person
1st name Hiroe
Middle name
Last name Washio
Organization Kansai University of International Studies
Division name School of Health Sciences
Zip code 673-0521
Address 1-18 Aoyama, Shijimi-cho, Miki 673-0521 Japan
TEL 0794-84-3513
Homepage URL
Email h-washio@kuins.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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 Kansai Uniniversity of International Studies
Address 1-18 Aoyama, Shijimi-cho, Miki, Hyogo 673-0521 Japan
Tel 0794-84-3513
Email h-washio@kuins.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
2012 Year 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2012 Year 05 Month 23 Day
Date of IRB
2012 Year 07 Month 17 Day
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine a relationship between feeling assessed by a questionnaire and stress-related substances/autonomic nervous tone in pregnancy and post-delivery. To do this study as a forward research. To perform this study in 78 pregnant women who agree to become the subjects of the study.

Management information
Registered date
2012 Year 05 Month 31 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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