Effectiveness of MMS Compared With IFS Among Pregnant Women in Bangladesh: an Experimental Study (NCT07540130) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Effectiveness of MMS Compared With IFS Among Pregnant Women in Bangladesh: an Experimental Study
Bangladesh667 participantsStarted 2025-02-11
Plain-language summary
Background Maternal undernutrition and micronutrient deficiencies remain highly prevalent in Bangladesh and contribute to maternal anaemia, low birth weight, preterm birth, and adverse neonatal outcomes. Although iron-folic acid supplementation (IFAS) is routinely provided through antenatal care services, it does not address the full spectrum of micronutrient deficiencies. Multiple micronutrient supplementation (MMS) has demonstrated superior outcomes in clinical trials; however, evidence from real-world programmatic settings in Bangladesh is limited.
Methods and analysis This experimental study will be conducted from March 2025 to March 2026 through antenatal care platforms coordinated by the Institute of Public Health Nutrition (IPHN), with centralised laboratory analysis at the National Institute of Neurosciences \& Hospital (NINS\&H), Dhaka. Pregnant women will receive either MMS or IFAS according to routine service delivery. The primary outcome is infant birth weight. Secondary outcomes include maternal haemoglobin and micronutrient biomarkers, preterm birth, dietary diversity, and supplementation adherence. Quantitative data will be analysed using multivariable regression models in SPSS with adjustments for confounders and geographic clustering. A concurrent process evaluation will assess implementation, fidelity and acceptability.
Ethics and dissemination Ethical approval has been obtained from the Institutional Review Board of NINS\&H. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, policy briefs, and stakeholder engagement workshops.
Who can participate
Age range15 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Confirmed pregnancy, preferably in the first trimester, with singleton pregnancy where feasible.
✓. Permanent residence within the selected study catchment areas and ability to remain in the study area throughout follow-up.
✓. Enrollment in IPHN-supported antenatal care or supplementation programs.
✓. Nutritional vulnerability identified through screening indicators (eg, MUAC, BMI, or hemoglobin).
✓. Willingness to receive MMS or IFAS supplementation as assigned by routine service delivery platforms.
✓. Provision of written informed consent (thumbprint with witness for illiterate participants).
✓. Planned facility-based delivery or verifiable delivery location.
Exclusion criteria
✕. Withdrawal of informed consent at any stage.
✕. Diagnosed chronic medical conditions likely to influence pregnancy outcomes or nutritional biomarkers (eg, diabetes, hypertension, thyroid disorders, thalassemia).
What they're measuring
1
infant birth weight
Timeframe: within 24 hours of delivery
Trial details
NCT IDNCT07540130
SponsorNational Institute of Neurosciences and Hospital, Dhaka