UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008074
Receipt number 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 18:12:18

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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

Obstetrics 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 or person

Institute

Kio University

Institute

Department

Personal name



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

Value
https://center6.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