An interventional study of mHealth education in Anemia and Pregnant Women, sponsored by Hiroshima University. Not yet recruiting at 1 site in Bangladesh. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Hiroshima University · Not applicable, Interventional, and Prevention
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.
Anemia is a public health problem in which the hemoglobin level becomes lower than the recommended value of 11.0 grams per deciliter (gm/dl) in blood. Generally, pregnant women are more vulnerable to developing anemia due to increased physiological demand for their growing fetus. In pregnancy, a low iron store is the most common cause of low hemoglobin levels, and therefore, 27 milligrams (mg) of oral iron needs to be taken daily during this period. A pregnant woman with anemia can experience fatigue, cold, shortness of breath, dizziness, headache, a fast heartbeat, restless leg syndrome, and so on. If this condition is untreated, adverse events can occur, such as preeclampsia, fatigue, hypertensive disorders, intrauterine growth restriction, placental abnormalities, threatened abortion, emotional disturbances, increased susceptibility to infections, poor weight gain, and preterm labor, which usually later lead to maternal or neonatal death.
Anemia during pregnancy is responsible for about 20% of maternal deaths per year, and globally its prevalence is 40.05%, including 42.7% in low- and middle-income countries (LMICs). The prevalence of anemia in South Asian countries is also alarming, and the rate of decline has been notably slow. Since the majority of the population in this region resides in rural areas, low literacy levels and poor financial conditions have led to limited access to proper healthcare. The long-term effect of gestational anemia is a loss of human productivity, which is one actual reason for the slow economic development in these regions. Like Nepal (43.1%), Pakistan (57.7%), and India (52.2%), Bangladesh is also noted to have a high prevalence (50%) of anemia among rural pregnant women. Unawareness about anemia, poverty, inadequate nutrition, early marriage, improper dietary practice, low educational qualification, women's unemployment, women's inequality, low access to health care facilities, low supplement compliance, and not visiting antenatal care (ANC) are the underlying factors of anemia among Bangladeshi pregnant women.
To control this issue, an effective intervention program is urgently needed to be implemented in this region. There are numerous programs available; however, educational intervention programs have been proven effective in these types of rural and low-resource settings. Usually, in these educational intervention programs, rural pregnant women are introduced to anemia, its symptoms, cause, consequences, when to see a doctor, how to manage this, effective preventive measures including Iron and Folic Acid (IFA) supplements, proper hygiene, dietary knowledge, and other things related to anemia reduction. By improving their lifestyle and awareness of anemia, this information ultimately helps them raise their hemoglobin level during pregnancy.
In Bangladesh, several educational intervention programs have been implemented previously; however, the national prevalence rate remains higher, with a target of being controlled under 25% by 2025. Until now, education programs in Bangladesh have been carried out at the community level or through a handbook. However, in these programs, factors such as forgetfulness, transportation issues, feeling weak, bad weather, inability to read, and being preoccupied with family are reported as causes of participant loss and program failure. Furthermore, the majority of them seek to reduce maternal risks among pregnant women by providing general maternal-related health information, but an educational intervention study solely focused on anemia in pregnancy has not been identified in Bangladesh.
In this digital technology era, using the telecommunication method to provide education-based intervention programs is expected to improve not only the accessibility of proper information on anemia management at the individual level but also affordability for the participants. Mobile-based Health (mHealth) education programs on anemia in pregnancy have been introduced in many other countries like Malaysia, Saudi Arabia, Ethiopia, and Nepal as an intervention. In these programs, voice calls, text, and/or audio messages through personal mobile phones have been used to deliver educational information to pregnant women. Moreover, in those studies, mHealth has given better results in increasing hemoglobin levels in pregnant women than many other conventional treatments. According to the Bangladesh Demographic Health Survey (BDHS) 2022 report, approximately 98% of the total population and 68% of rural married women aged between 15-49 years own at least one mobile phone in Bangladesh. In addition, a previous study confirmed that using a mobile phone for pregnancy-related purposes has a positive relation with mothers' receipt of antenatal care in Bangladesh. Therefore, we should seize this opportunity to strengthen maternal healthcare and evaluate mHealth-based education for improving hemoglobin levels in anemic pregnant women, an area yet to be studied. Due to this existing gap and need, this study aims to evaluate the impact of mHealth education on anemia, specifically focusing on its effectiveness in increasing hemoglobin levels among anemic pregnant women in rural areas of Bangladesh.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 132 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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- 1. Pregnant women who will be diagnosed with mild and moderate anemia (Blood levels are between 7g/dL and 10.9 g/dL).
2. Have at least one active mobile phone in the family. 3. Those who will give written to participate in the intervention study at the time of enrollment
Exclusion Criteria:
- 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.
3. Those who have severe anemia. 4. Having the possibility of leaving the study area during this study period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
mHealth education intervention to increase hemoglobin level in pregnancy
Other: mHealth education
No mHealth education: Usual care
Mobile health education to increase hemoglobin level among pregnant women
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.
Time frame: 4 months
Plan to share: No — Due to ethical constraints, the IPD will be securely stored and will not be shared with researchers outside the primary research team.
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Hiroshima University