UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021980
Receipt number R000025279
Scientific Title Study on development of coparenting intervention program for Japanese couple during pregnancy
Date of disclosure of the study information 2016/06/02
Last modified on 2018/04/24 10:19:58

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Basic information

Public title

Study on development of coparenting intervention program for Japanese couple during pregnancy

Acronym

Study on development of coparenting intervention program during pregnancy

Scientific Title

Study on development of coparenting intervention program for Japanese couple during pregnancy

Scientific Title:Acronym

Study on development of coparenting intervention program during pregnancy

Region

Japan


Condition

Condition

pregnancy

Classification by specialty

Obstetrics and Gynecology Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of coparenting intervention program during pregnancy for Japanese couple who is expected to have a first child

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

High score of Coparenting relationship Scale 1month and 3 months after having a first child

Key secondary outcomes

Marital Love, Marital Adjustment, Prenatal Comfort, Depression, parent to infant bonding


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention Group
4 session of antenatal intervention program based on Family Foundation Program(R)
Managed by midwives who are trained and have more than 3 years clinical experience.
1st [Building a family]
2nd [Feelings & conflict]
3rd [Teamwork]
4th [Working it out]

Interventions/Control_2

Control group
Normal antenatal education program at clinic or hospital

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

Male and Female

Key inclusion criteria

Japanese
Couple who are expected to have a first child
be able to read and write Japanese

Key exclusion criteria

severe psychological illness
poor prognosis in a fetus

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuka NAKAMURA

Organization

Tohoku University

Division name

Graduate school of Medicine Womens health nirsing

Zip code


Address

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

TEL

022-171-7957

Email

ynaka@tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuka NAKAMURA

Organization

Tohoku University

Division name

Graduate school of Medicine Womens health nirsing

Zip code


Address

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

TEL

022-171-7957

Homepage URL


Email

ynaka@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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


Address


Tel


Email



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

2016 Year 06 Month 02 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

Completed

Date of protocol fixation

2016 Year 06 Month 02 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 19 Day

Last modified on

2018 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name