UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035423
Receipt number R000040357
Scientific Title Effectiveness of Preventing Second-hand Smoke for Pregnant Women at Home Using an Educational Comic Booklet in Indonesia: A Randomized Controlled Trial
Date of disclosure of the study information 2019/02/01
Last modified on 2024/01/09 11:14:18

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Basic information

Public title

Effectiveness of Preventing Second-hand Smoke for Pregnant Women at Home Using an Educational Comic Booklet in Indonesia: A Randomized Controlled Trial

Acronym

Effectiveness of Preventing Second-hand Smoke for Pregnant Women at Home Using an Educational Comic Booklet in Indonesia: A Randomized Controlled Trial

Scientific Title

Effectiveness of Preventing Second-hand Smoke for Pregnant Women at Home Using an Educational Comic Booklet in Indonesia: A Randomized Controlled Trial

Scientific Title:Acronym

Effectiveness of Preventing Second-hand Smoke for Pregnant Women at Home Using an Educational Comic Booklet in Indonesia: A Randomized Controlled Trial

Region

Asia(except Japan)


Condition

Condition

Second-hand smoke among pregnant women

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine the effectiveness of preventing second-hand smoke for pregnant women at home in order to reduce SHS exposure in pregnancy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Three months post-intervention:Behavior responses of pregnant women and their husband will be used three months later from implementation.For pregnant women,Avoidance of Environmental Tobacco Scale(19 items)and partner's behavior changes which will be evaluated by (9 items). For their husband, husband's behavior change(9 items)and wife's behavior change(3 items) which will be evaluated by husband.
After delivery:Birth weight,height,baby's gender and gestational age at delivery

Key secondary outcomes

Three month post-intervention:(1)Pregnant women:knowledge on secondhand smoke(8 items),health believes and self-efficacy(38 items), (2)Husband:knowledge on secondhand smoke(8 items),health believes and self-efficacy(32 items)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Educational material,Reminder

Interventions/Control_2

Usual care

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

Male and Female

Key inclusion criteria

Targets will be married couples who are 18 years old over and live in Menado or Tomohon city in Indonesia.

Inclusion criteria for married pregnant women,
(1)non-smoking pregnant women in their first-trimester pregnancy: up to 12 weeks gestation,
(2)having Second-hand smoke exposure from their husband(19 years of age or older).

Inclusion criteria for married their husbands,
(1)Smoking at least six cigarettes per week or more within two months before or since pregnancy that is one of inclusion criteria for their husband.
(2)Their husbands living in the same household will be eligible for inclusion in the trial.

Key exclusion criteria

The criteria for exclusion include termination of pregnancy after the second trimester pregnancy, active smoking pregnant women, high risk pregnant women having clinical diseases, gestational diabetes, pregnancy-induced hypertension or suffering from mental disorders

Target sample size

404


Research contact person

Name of lead principal investigator

1st name Kimiko
Middle name
Last name Inaoka

Organization

International University of Health and Welfare Narita

Division name

Graduate school of nursing science, Global Health Nursing

Zip code

286-8686

Address

4-3,Kozunomori,Narita-shi,Chiba 286-8686 Japan

TEL

81-476-20-7701

Email

k-inaoka@iuhw.ac.jp


Public contact

Name of contact person

1st name Kimiko
Middle name
Last name Inaoka

Organization

International University of Health and Welfare Narita

Division name

Graduate school of nursing science, Global Health Nursing

Zip code

286-8686

Address

4-3,Kozunomori,Narita-shi,Chiba 286-8686 Japan

TEL

81-476-20-7701

Homepage URL


Email

k-inaoka@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare Narita

Institute

Department

Personal name



Funding Source

Organization

Japanese Governmental office

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sam Ratulangi University,Indonesia

Name of secondary funder(s)



IRB Contact (For public release)

Organization

International University of Health and Welfare Narita

Address

4-3,Kozunomori,Narita-shi,Chiba 286-8686 Japan

Tel

0476-35-5613

Email

rinri_md@iuhw.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

2019 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

https://www.mdpi.com/2227-9032/11/23/3061

Number of participants that the trial has enrolled

286

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data collection was delayed because of COVID-19.
Main results have been published.
We are currently preparing to publish the results of analysis of baby's data(birth height, birth weight, weeks at birth).

Date of the first journal publication of results

2023 Year 11 Month 28 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 01 Month 30 Day

Date of IRB

2019 Year 01 Month 25 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 01 Day

Last modified on

2024 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040357


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name