AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Muttaquina Hossain, MPH contact

+88-01923758956

muttaquina@icddrb.org

Kazi Istiaque Sanin, MPH contact

Bangladesh1 site, 1 recruiting
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka, 1212

    Muttaquina Hossain, MPH, muttaquina@icddrb.org

    Kazi Istiaque Sanin, MPH, sanin@icddrb.org

    Recruiting

Other trials in Bangladesh

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).

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 groups in NCT05108454
Study groupRoleWhat they receive
Intervention groupPregnant women who received MMS from the SMC program
Receives: Drug: Multiple micronutrient supplementation
ComparisonPregnant women who did not receive MMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Low birth weight babies

    Babies born with birth weight less than 2500 grams

    Measured: November 2021 to June 2024

Secondary outcomes (4)
  1. Percentage of Preterm children

    Babies born less than 37 weeks of gestation

    Measured: November 2021 to June 2024

  2. 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

  3. 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

  4. 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.

  1. First posted5 Nov 2021
  2. Study start15 Dec 2021
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in