UMIN-ICDS Clinical Trial

Public title

Impact of mHealth Education in Improving Maternal Knowledge and Psychosocial Well-being for the Prevention of Pregnancy Complications with Caregiver Involvement in Rural Bangladesh

Acronym

mHealth Supporter Study Bangladesh

Scientific Title

Impact of mHealth Education in Improving Maternal Knowledge and Psychosocial Well-being for the Prevention of Pregnancy Complications with Caregiver Involvement in Rural Bangladesh

Scientific Title:Acronym

mHealth Education with Supporter Participation for Pregnant Women in Bangladesh

Region

Asia(except Japan)

Condition

Pregnancy-related complications

Classification by specialty

Obstetrics and Gynecology

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of an mHealth-based maternal and child health education intervention involving a primary supporter on maternal knowledge of antenatal care (ANC) and danger signs during pregnancy, birth preparedness, perceived social support, psychological well-being, maternal health service utilization, and maternal and neonatal outcomes among pregnant women in rural Bangladesh.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change from baseline to the end of the 6-month intervention in maternal knowledge scores regarding antenatal care (ANC) and danger signs during pregnancy, assessed using a 13-item structured questionnaire.

Key secondary outcomes

1) Change in Birth Preparedness Questionnaire (BPQ) scores from baseline to the end of the intervention. 2) Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to the end of the intervention. 3) Change in maternal psychological well-being assessed using the Edinburgh Postnatal Depression Scale (EPDS) from baseline to the end of the intervention. 4) Utilization of antenatal care at the end of the intervention, including timing of initiation and number of ANC visits. 5) Maternal and neonatal outcomes assessed at the end of the intervention, including gestational age at delivery, mode and place of delivery, occurrence of danger signs during pregnancy, initiation of breastfeeding, neonatal condition and complications, birth weight, and vaccination status.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Other

Interventions/Control_1

In addition to usual care, participants will receive a 6-month mHealth-based maternal and child health education intervention. During the first 4 months, participants will receive educational SMS messages twice per month and voice calls twice per month (weeks 1 and 3), lasting at least 5 minutes per call. During months 5 and 6, participants will receive four SMS messages per month and weekly voice calls lasting at least 5 minutes. Reminders will be provided before each antenatal care (ANC) visit, and a monthly self-assessment checklist will be used to assess ANC attendance, danger signs during pregnancy, birth preparedness, and health concerns. During the final 2 months, quizzes on the educational content will be conducted by voice call. In addition, one primary supporter selected by each participant will receive education and counseling regarding ANC, danger signs during pregnancy, birth preparedness, nutrition, and psychosocial support.

Interventions/Control_2

Participants will receive usual care only. No additional study-specific mHealth education, SMS messages, voice calls, ANC visit reminders, self-assessment checklists, or education and counseling for the primary supporter will be provided.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1.Pregnant women aged 18 years or older who are in early pregnancy.
2.Women with a confirmed ongoing pregnancy.
3.Women classified as having insufficient or moderate knowledge of antenatal care (ANC) and danger signs during pregnancy at the baseline assessment.
4.Women who have access to and are able to use a mobile phone.
5.Women who are willing to participate in the study and are able to provide written informed consent after receiving an adequate explanation of the study.

Key exclusion criteria

1.Women with a confirmed molar pregnancy or ectopic pregnancy.
2.Women whose pregnancy was achieved through in vitro fertilization (IVF).
3.Women with chronic diseases such as cancer, heart disease, or kidney disease.

Target sample size

152

Name of lead principal investigator

1st name	Yoko
Middle name
Last name	Shimpuku

Organization

Hiroshima University

Division name

Graduate School of Biomedical and Health Sciences Program of Health Sciences

Zip code

734-8553

Address

1 Chome-2-3- Kasumi, Minami Ward, Hiroshima, Japan

TEL

082-257-5555

Email

yokoshim@hiroshima-u.ac.jp

Name of contact person

1st name	Bilkis
Middle name
Last name	Banu

Organization

Independent University, Bangladesh

Division name

Department of Public Health, School of Pharmacy and Public Health

Zip code

1245

Address

Plot 16, Block B, Aftabuddin Ahmed Road, Bashundhara Residential Area, Bangladesh

TEL

8801716245245

Homepage URL

Email

bilkis@iub.edu.bd

Institute

Independent University, Bangladesh

Institute

Department

Personal name

Bilkis Banu

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

Kasumi 1-2-3 Minami-Ku, Hiroshima

Tel

082-257-1947

Email

iryo-sinsa@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2026

Year

08

Month

17

Day

Date of IRB

2026

Year

10

Month

28

Day

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2027

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

29

Day

Last modified on

2026

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071714