NCT07310680

Brief Summary

Anemia in pregnancy can result in negative pregnancy outcomes, which are higher among pregnant women of rural Bangladesh. A cost-effective health education program is urgently needed to introduce, which will help to improve their hemoglobin level by changing their lifestyle. In many rural settings, mobile-based health (mHealth) education programs have been shown to improve hemoglobin levels effectively during the antenatal period. So, we aim to assess the impact of a mHealth education program on improving hemoglobin levels among anemic pregnant women of rural Bangladesh. The study will be carried out in the rural settings of a district of Bangladesh named Chandpur. This study timeline is from December 2025 to May 2026. After this survey, a randomized controlled trial study will be conducted where 160 pregnant women who are diagnosed with mild and moderate anemia will be offered to participate. Pregnant women who will give informed consent will be randomly assigned to two arms: intervention and control. Every arm will have an equal number of anemic pregnant women. Pregnant women in the intervention arm will receive anemia management-related health education through mobile messages and calls. This intervention program will educate pregnant women about the causes, risks, and symptoms of anemia, with the prevention strategies like dietary improvement, supplementation, parasitic disease control, safe motherhood, family planning, and iron-rich food production. Additionally, they will get regular care, a booklet and reminders of ANC visits during the study period. In contrast, the pregnant women of the control arm will receive regular care during this period, but after the end-line assessment, they will also get the booklet. After 4 months of the intervention program, the end-line assessment will be done, where the hemoglobin, nutritional status, and literacy about anemia will be assessed. Multiple comparisons will be performed by two-way analysis of variance tests for the evaluation of the outcome variables. Additionally, a Generalized Estimating Equations (GEE) model will be used to analyze the effect of the mHealth education program on related factors. A p-value less than 0.5 will be considered significant in this study. If this mHealth-based education program shows improvement in hemoglobin level, this can be utilized in low-resource settings widely to ensure safe pregnancy outcomes in the future.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 24, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

AnemiaPregnant womenmHealthBangladesh

Outcome Measures

Primary Outcomes (1)

  • Correlation of mHealth education intervention with changes in blood hemoglobin level

    Individual pregnant women will have their anemia status assessed (non-anemic, mild, moderate, and severe anemia) based on blood hemoglobin measurement using an automated hematology analyzer. According to the World Health Organization (WHO), hemoglobin levels \<11.0 g/dL will be considered indicative of anemia among pregnant women. Hemoglobin concentrations of 10.0-10.9 g/dL, 7.0-9.9 g/dL, and \<7.0 g/dL will be classified as mild, moderate, and severe anemia, respectively, while hemoglobin levels ≥11.0 g/dL will be considered non-anemic. Following the mHealth education intervention, changes in anemia status will be assessed from baseline to endline among pregnant women, including transitions from anemic to non-anemic, severe to moderate/mild/non-anemic, moderate to mild/non-anemic, and mild to non-anemic, in both the intervention and control groups.

    4 months

Study Arms (2)

Mobile health education intervention

EXPERIMENTAL

mHealth education intervention to increase hemoglobin level in pregnancy

Other: mHealth education

Usual care: Control group

NO INTERVENTION

No mHealth education: Usual care

Interventions

Mobile health education to increase hemoglobin level among pregnant women

Mobile health education intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 1. Pregnant women who will be diagnosed with mild and moderate anemia (Blood hemoglobin levels are between 7g/dL and 10.9 g/dL).
  • \. Have at least one active mobile phone in the family. 3. Those who will give written informed consent to participate in the intervention study at the time of enrollment

You may not qualify if:

  • \- 1. Hospitalized at the time of the study period. 2. Women with any known or suspected chronic or congenital disease, such as blood inflammation, diabetic mellitus, thalassemia, hypertension, and psychiatric illness.
  • \. Those who have severe anemia. 4. Having the possibility of leaving the study area during this study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upazilla Health Complex and Community Clinic

Chāndpur, Bangladesh

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yoko Shimpuku, RN PhD

    Graduate School of Biomedical and Health Sciences, Hiroshima university

    STUDY DIRECTOR

Central Study Contacts

Taiyaba Tabassum Ananta, Doctoral Student

CONTACT

Md Moshiur Rahman, MD, MPH, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student (PhD)

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 30, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Due to ethical constraints, the IPD will be securely stored and will not be shared with researchers outside the primary research team.

Locations