UMIN-CTR Clinical Trial

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