UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034418
Receipt number R000039245
Scientific Title The state of birth preparation and its impact on physical and mental health after giving birth
Date of disclosure of the study information 2018/11/01
Last modified on 2021/04/14 16:31:11

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Basic information

Public title

The state of birth preparation and
its impact on physical and mental health after giving birth

Acronym

Development for evaluation measures about the state of birth preparation

Scientific Title

The state of birth preparation and
its impact on physical and mental health after giving birth

Scientific Title:Acronym

Development for evaluation measures about the state of birth preparation

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The birth preparation state scale to prove its reliability and validity

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The factor affects the birth preparation state

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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Saliva collection

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

18 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

low risk pregnant and parturient women

Key exclusion criteria

High risk pregnant and parturient women

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Fujiko
Middle name
Last name Omine

Organization

University of The Ryukyus Faculty of Medicine

Division name

Department of Health science

Zip code

903-0215

Address

207 Uehara Nishihara-Town Okinawa

TEL

098-895-3331

Email

Omine-f@med.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name Rika
Middle name
Last name Takemoto

Organization

University of The Ryukyus Faculty of Medicine

Division name

Department of Health science

Zip code

903-0215

Address

207 Uehara Nishihara-Town Okinawa

TEL

098-895-3331

Homepage URL


Email

K168872@eve.u-ryukyu.ac.jp


Sponsor or person

Institute

University of The Ryukyus Faculty of Medicine Department of Health science

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of The Ryukyus Faculty of Medicine Department of Health science

Address

207 Uehara Nishihara-Town Okinawa

Tel

098-895-3331

Email

Omine-f@med.u-ryukyu.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

2018 Year 11 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

0

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

Terminated

Date of protocol fixation

2017 Year 06 Month 25 Day

Date of IRB

2020 Year 05 Month 15 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 09 Day

Last modified on

2021 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name