Infant, Low Birth WeightNCT05108454
Multiple Micronutrient Supplementation (MMS) Evaluation Among Bangladeshi Pregnant Women
An observational study of Infant, Low Birth Weight, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Infant, Low Birth Weight
- What is being tested?
- Multiple micronutrient supplementation
- How many people
- 4,500 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Dec 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant mothers live in either intervention or control areas in any trimester of pregnancy.
Who may be able to join
- 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
Who cannot join
- Non-pregnant
- Declined to participate
Trial locations and contacts
1 site in 1 country.
Kazi Istiaque Sanin, MPH contact
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
Muttaquina Hossain, MPH, muttaquina@icddrb.org
Kazi Istiaque Sanin, MPH, sanin@icddrb.org
About this study
Official title: Evaluation of a Business Model of Multiple Micronutrient Supplementations (MMS) Project for Bangladeshi Pregnant Women
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.
Read the detailed description
Background: a. Burden: 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. Furthermore, these babies have a higher risk of stunting or linear growth failure and slower mental development in childhood. b. Knowledge gap: 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) has updated the antenatal nutrition recommendations. Now, MMS is recommended 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. Furthermore, the MMS tablets are expensive compared to the IFA, which might hinder the uptake of the MMS by the people. c. Relevance: 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.
Hypothesis: The prevalence of LBW will be reduced by 5% point in the intervention group compared to the control group by the end of the 5-year program.
Objectives: Outcome evaluation- To evaluate the effectiveness of market-based distribution of MMS intervention on the prevalence of low birth weight (less than 2500 g) in the infants born to women in the intervention area who received the intervention compared to control areas Process evaluation- To measure the fidelity, reach and mechanism of impact of the intervention
Methods: 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: Barishal, Chattogram, Dhaka, Rajshahi, and Sylhet. For outcome evaluation: Eligible pregnant women will be approached for recruitment with proper consent. Right after recruitment, a baseline data collection will be conducted using a structured questionnaire along with anthropometric measurements. The recruited participants will be followed up until the end of their pregnancy. After successful delivery of a baby, an endpoint data collection will be done along with birth weight measurement of the baby. Data from the control areas will be collected following the same guideline to maintain consistency. The process evaluation will be carried out concurrently to monitor the program activities. This will follow a mixed-method design, including both quantitative and qualitative components. The participants will be recruited from the same area where activity for outcome evaluation will be ongoing. The investigators will focus on the fundamental aspects of process evaluation that includes- (a) understanding the health promotion program and how it is supposed to work, (b) defining the purposes for the process evaluation, and (c) considering program characteristics and context and how these may affect implementation.
Outcome measures/variables: The key variable for outcome evaluation is the measurement of birth weight. Key variables for process evaluation are fidelity, reach, and mechanism of impact of the intervention (MMS).
- Conditions
- Infant, Low Birth Weight
- Being tested
- Multiple micronutrient supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplementationDrug
Also called MMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Pregnant women who received MMS from the SMC program Receives: Drug: Multiple micronutrient supplementation | |
| Comparison | Pregnant women who did not receive MMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Low birth weight babies
Babies born with birth weight less than 2500 grams
Measured: November 2021 to June 2024
Secondary outcomes (4)
Percentage of Preterm children
Babies born less than 37 weeks of gestation
Measured: November 2021 to June 2024
Number of pregnant women with MMS side effects, compliance, & adverse perinatal outcomes
MMS side effects: Any side effects of MMS reported by the pregnant mothers. MMS compliance: Pregnant mothers intake of 180 MMS tablets once a day for 6 months.
Adverse perinatal outcomes: Any maternal and child health complication before and after child delivery.
Measured: November 2021 to June 2024
Percentages of contact and effective coverage for the intervention group
Reach and utilization of MMS and compliance of pregnant women who consumed MMS
Measured: November 2021 to June 2024
Number of pregnant women with their duration of gestation
Duration of pregnancy in months among the pregnant women at both intervention and control group
Measured: November 2021 to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start15 Dec 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Investment Fund Foundation
- Responsible party
- Sponsor
- Investigators
- Muttaquina Hossain, MPH, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108454
- Sponsor's protocol ID
- PR-21001
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35636782
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Business Model of Multiple Micronutrient Supplementations (MMS) Project for Bangladeshi Pregnant Women
- ClinicalTrials.gov ID
- NCT05108454
- Acronym / sponsor ID
- PR-21001
- Conditions
- Infant, Low Birth Weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Children's Investment Fund Foundation
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: a. Burden: 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. Furthermore, these babies have a higher risk of stunting or linear growth failure and slower mental development in childhood. b. Knowledge gap: 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) has updated the antenatal nutrition recommendations. Now, MMS is recommended 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. Furthermore, the MMS tablets are expensive compared to the IFA, which might hinder the uptake of the MMS by the people. c. Relevance: 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.
Hypothesis: The prevalence of LBW will be reduced by 5% point in the intervention group compared to the control group by the end of the 5-year program.
Objectives: Outcome evaluation- To evaluate the effectiveness of market-based distribution of MMS intervention on the prevalence of low birth weight (less than 2500 g) in the infants born to women in the intervention area who received the intervention compared to control areas Process evaluation- To measure the fidelity, reach and mechanism of impact of the intervention
Methods: 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: Barishal, Chattogram, Dhaka, Rajshahi, and Sylhet. For outcome evaluation: Eligible pregnant women will be approached for recruitment with proper consent. Right after recruitment, a baseline data collection will be conducted using a structured questionnaire along with anthropometric measurements. The recruited participants will be followed up until the end of their pregnancy. After successful delivery of a baby, an endpoint data collection will be done along with birth weight measurement of the baby. Data from the control areas will be collected following the same guideline to maintain consistency. The process evaluation will be carried out concurrently to monitor the program activities. This will follow a mixed-method design, including both quantitative and qualitative components. The participants will be recruited from the same area where activity for outcome evaluation will be ongoing. The investigators will focus on the fundamental aspects of process evaluation that includes- (a) understanding the health promotion program and how it is supposed to work, (b) defining the purposes for the process evaluation, and (c) considering program characteristics and context and how these may affect implementation.
Outcome measures/variables: The key variable for outcome evaluation is the measurement of birth weight. Key variables for process evaluation are fidelity, reach, and mechanism of impact of the intervention (MMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Drug: Multiple micronutrient supplementationPregnant women who received MMS from the SMC program |
| Comparison | – | –Pregnant women who did not receive MMS |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant mothers live in either intervention or control areas in any trimester of pregnancy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Non-pregnant
- Declined to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient supplementationAlso: MMSMultiple 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. | Drug | Intervention group |
Primary outcome
Percentage of Low birth weight babies
Time frame: November 2021 to June 2024
Babies born with birth weight less than 2500 grams
4 secondary outcomes
Percentage of Preterm children
Time frame: November 2021 to June 2024
Number of pregnant women with MMS side effects, compliance, & adverse perinatal outcomes
Time frame: November 2021 to June 2024
Percentages of contact and effective coverage for the intervention group
Time frame: November 2021 to June 2024
Number of pregnant women with their duration of gestation
Time frame: November 2021 to June 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 35636782Hossain 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazi Istiaque Sanin, MPH contact
Muttaquina Hossain, MPH principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Low Birth Weight, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muttaquina Hossain, MPH (+88-01923758956, muttaquina@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Low birth weight babies (time frame: November 2021 to June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.