UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046270
Receipt number R000052801
Scientific Title Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples
Date of disclosure of the study information 2021/12/03
Last modified on 2023/06/05 09:11:43

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Basic information

Public title

Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples

Acronym

Co-parenting program for Iranian Couples

Scientific Title

Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples

Scientific Title:Acronym

Co-parenting program for Iranian Couples

Region

Asia(except Japan)


Condition

Condition

pregnancy

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

coparenting relationship

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

coparenting promote program

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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

(1)a couple who will have their first child
(2) Those who can read and write Farsi.
(3) A couple lives together.
(4) Have an Internet connection such as a smartphone or PC (necessary for registration and questionnaire responses and attend at classes).

Key exclusion criteria

(1) Not living with a couple or children at the time of recruitment
(2) Those who are unable to read and write Farsi.
(3) Same-sex couples
(4) Other cases in which the researcher deems participation in the study to be inappropriate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Toyoko
Middle name
Last name YOSHIZAWA

Organization

Tohoku University,Graduate School of Medicine

Division name

Women's health nursing & midwifery

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku,sendai

TEL

+81227177915

Email

toyoko@nursing.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Yasuka
Middle name
Last name NAKAMURA

Organization

Tohoku University,Graduate School of Medicine

Division name

Women's health nursing & midwifery

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku,sendai

TEL

+81227177957

Homepage URL


Email

ynaka@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku 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

Tohoku University Graduate school of Med

Address

2-1,Seiryomachi, aobaku, sendai

Tel

022-717-7957

Email

ynaka@tohoku.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

2021 Year 12 Month 03 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

100

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

No longer recruiting

Date of protocol fixation

2021 Year 12 Month 03 Day

Date of IRB

2022 Year 02 Month 28 Day

Anticipated trial start date

2022 Year 02 Month 28 Day

Last follow-up date

2023 Year 05 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

2021 Year 12 Month 03 Day

Last modified on

2023 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name