UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012575
Receipt number R000014708
Scientific Title A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period
Date of disclosure of the study information 2013/12/18
Last modified on 2019/07/07 11:34:44

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Basic information

Public title

A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period

Acronym

Investigation of the Effectiveness of Childhood Immunization Education Program for Parents

Scientific Title

A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period

Scientific Title:Acronym

Investigation of the Effectiveness of Childhood Immunization Education Program for Parents

Region

Japan


Condition

Condition

women during perinatal period

Classification by specialty

Obstetrics and Gynecology Pediatrics Nursing
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the efficacy of the education program for parents on childhood immunization devised to fit the situation of Japan where voluntary vaccines exist.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

An immunization up-to-date status when the infant is at three months of age for HBV vaccine

Key secondary outcomes

An immunization up-to-date status when the infant is at three months of age for Rotavirus vaccine, Hib vaccine, and PCV13
Parental discussion about vaccinations
Looking for the primary physician for receiving vaccinations
A change in maternal intention to receive immunization, knowledge, attitudes and beliefs, and health literacy between the pre-study evaluation and post-study evaluation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention
In addition to the usual perinatal checkups and health education, the participants in an intervention group receive both (1) and (2). If possible, participant's husband (partner) or family would also be present in the sessions.
(1) During late pregnancy, pregnant women who visit prenatal check-up receive individual immunization education for 10 min.
(2) At one-month postpartum checkup, postpartum women are supposed to check whether being prepared to receive immunization for 3-5 min.

Interventions/Control_2

Control
The participants in a control group receive the usual perinatal checkups and health education.

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


Not applicable

Gender

Female

Key inclusion criteria

Correspond to all of the following in recruitment of participants at 29-33 weeks of gestation
(1) Pregnant women 18 years or older
(2) Pregnant women have a good command of written and spoken Japanese.
(3) Pregnant women can receive two interventions (late pregnancy and one month after the delivery).

Key exclusion criteria

Correspond to any of the following
(1) It is predicted that birth weight is estimated at less than 2000g due to intrauterine growth restriction (IUGR), or others.
(2) It is predicted that there is need for newborn hospitalization for more than one month.
(3) Those who are judged not capable of participating in the study by the obstetrician or midwife and nurse

Target sample size

175


Research contact person

Name of lead principal investigator

1st name Kiyoko
Middle name
Last name Kamibeppu

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Family Nursing, Division of Health Sciences & Nursing

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN

TEL

03-5841-3556

Email

kkamibeppu-tky@umin.ac.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Otsuka-Ono

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Family Nursing, Division of Health Sciences & Nursing

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN

TEL

03-5841-3399

Homepage URL


Email

hirokoo-tky@umin.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Pfizer Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Institutional Ethics Review Board of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2013 Year 12 Month 18 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

2013 Year 11 Month 28 Day

Date of IRB

2013 Year 12 Month 16 Day

Anticipated trial start date

2013 Year 12 Month 18 Day

Last follow-up date

2014 Year 09 Month 03 Day

Date of closure to data entry

2014 Year 09 Month 03 Day

Date trial data considered complete

2014 Year 09 Month 03 Day

Date analysis concluded

2015 Year 01 Month 28 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 14 Day

Last modified on

2019 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014708


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name