Multiple Micronutrient Supplementation (MMS) Evaluation Among Bangladeshi Pregnant Women
Evaluation of a Business Model of Multiple Micronutrient Supplementations (MMS) Project for Bangladeshi Pregnant Women
1 other identifier
observational
4,500
1 country
1
Brief Summary
Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy and later childhood. A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) recommended MMS during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh. The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 8, 2022
March 1, 2022
2.5 years
October 25, 2021
March 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Low birth weight babies
Babies born with birth weight less than 2500 grams
November 2021 to June 2024
Secondary Outcomes (4)
Percentage of Preterm children
November 2021 to June 2024
Number of pregnant women with MMS side effects, compliance, & adverse perinatal outcomes
November 2021 to June 2024
Percentages of contact and effective coverage for the intervention group
November 2021 to June 2024
Number of pregnant women with their duration of gestation
November 2021 to June 2024
Study Arms (2)
Intervention group
Pregnant women who received MMS from the SMC program
Comparison
Pregnant women who did not receive MMS
Interventions
Multiple Micronutrient Supplements (MMS) is a nutritional supplement for use during pregnancy based on United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation following WHO specification. It contains 15 micronutrients including Iron and Folic Acid (IFA) at dosages that approximate the recommended dietary allowances for pregnancy.
Eligibility Criteria
Pregnant mothers live in either intervention or control areas in any trimester of pregnancy.
You may qualify if:
- Singleton pregnancy identified/reported through ultrasonogram during ANC or other available medical proof
- Absence of severe malnourishment/known chronic diseases- respiratory illness, hypertension, diabetes, TB, haemoglobinopathy, etc. through self-reporting and available documents
- Participant willingness to participate
- Provide at least two mobile numbers to contact
- The place of delivery has been decided
You may not qualify if:
- Non-pregnant
- Declined to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212, Bangladesh
Related Publications (1)
Hossain M, Sanin KI, Haque MA, Mbuya MNN, Ghosh S, Aksari S, Gibson S, Neufeld L, Bipul M, Matubbar S, Rahman MM, Khondker R, Salasibew M, Ahmed T. Evaluating the impact of a countrywide, market-based roll-out of multiple micronutrient supplementation on low birth weight in Bangladesh: protocol for a two-arm, quasi-experimental and mixed-methods evaluation study. BMJ Open. 2022 May 30;12(5):e060230. doi: 10.1136/bmjopen-2021-060230.
PMID: 35636782DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Muttaquina Hossain, MPH
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Study Contacts
Kazi Istiaque Sanin, MPH
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 5, 2021
Study Start
December 15, 2021
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After the study completes.
- Access Criteria
- icddr,b study investigators.
We will strictly follow the icddr,b's ethical guideline and practice to ensure the confidentiality of information collected through this study. The name and phone number(s) of the respondent will not be included in the data set. All data will be stored in a password-protected PC having access to only selected individual(s) using STATA software in a specified drive. After a specific time, data be backed up in three places such as another drive in the same computer, in a PI's computer, and in an additional hard drive which will be placed in a secured location. The information collected from this study may be shared with other researchers if needed only for research purposes, however, it will be strictly followed to maintain confidentiality and privacy and as per the icddr,b's data access policy.