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Maternal Nutritional Deficiency During ChildbirthNCT04559711

cRCT to Improve Maternal Nutrition Service Delivery During ANC

A study testing Strengthening coverage and quality of nutrition services during ANC in people with Maternal Nutritional Deficiency During Childbirth, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Malnutrition among women of reproductive age is a significant public health problem in Bangladesh, with major implications for a woman's own health and that of her newborn child. The principal drivers for maternal malnutrition in Bangladesh are poor-quality diets, care seeking practices and access to health care. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
What is being tested?
Strengthening coverage and quality of nutrition services during ANC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,520 participants
Where
1 siteBangladesh
Study dates
1 Oct 2020to 31 Dec 2022
Phase
Interventional
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 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women coming for ANC in the public health facilities
  • Provide consent to participate in the study

Who cannot join

  • pregnant women who will not provide consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Sk Masum Billah, MPH contact

+61484192204

billah@icddrb.org

Nazia Binte Ali, MPH, MBBS contact

+8801751789769

nazia.ali@icddrb.org

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

    Bogura

    Nazia Binte Ali, MPH, MBBS, +88029827001-10, nazia.ali@icddrb.org

    Recruiting

Other trials in Bangladesh

About this study

Official title: Demonstration Programme to Improve Maternal Nutrition Service Delivery Including Multiple Micronutrient Supplementation (MMS) Through Public Health ANC Platforms: A Community Based Cluster Randomized Control Trial

Malnutrition among women of reproductive age is a significant public health problem in Bangladesh, with major implications for a woman's own health and that of her newborn child. The principal drivers for maternal malnutrition in Bangladesh are poor-quality diets, care seeking practices and access to health care. An ideal contact point for pregnant women are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate with just 29% of pregnant women attending all 4 ANC visits and 18% of women consuming at least 100 IFA tablets. Moreover, WHO made a context specific recommendation that countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB, Sight \& Life, Pennsylvania State University (PSU) and icddr, b to design and assess outcome of a community based randomized control trial to improve coverage and quality of maternal nutrition service delivery through ANC platform. The investigators hypothesize that implementation of demonstration programme will result in 60% relative improvement in the coverage of 100+ MMS among women who received 4+ANC in the intervention areas compared to the coverage of 100+ IFA among women who received 4+ANC in comparison areas.

Read the detailed description
  1. Burden: Globally, it is recognized that pre-conception and during pregnancy malnutrition among women is an underlying cause of maternal morbidity, mortality, and poor birth outcomes including low birth weight babies. In Bangladesh, the poor pre-conception and pregnancy nutritional status of women contributes to the prevailing high rates of low birth weight among newborns. Each year, approximately 860,000 or 28% of babies are born with low birth weight (<2500g) greatly increasing their risk of stunting and wasting, and diet-related non-communicable diseases in adult life.
  2. Knowledge gap: An ideal contact point for pregnant women for delivering nutrition services are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate in terms of coverage and quality. Overall 29% of pregnant women in Bangladesh receive 4 ANC and 18% of women consume at least 100 IFA tablets. Moreover recent WHO context specific recommendation suggest countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB and icddr, b to build a comprehensive understanding of where gaps in ANC and nutritional care delivery currently exist, how to bridge these gaps, strengthen both the supply and service system, engage with a larger number of pregnant women, and finally encourage the adoption of the programme across Bangladesh.
  3. Relevance:

The most recent State of Food Security and Nutrition in Bangladesh Report found that 66% of women did not consume adequately diversified diets, indicating micronutrient deficiencies. A growing body of evidence has found that multiple micronutrient supplementation (MMS) may result in better neonatal outcomes for undernourished pregnant women. MMS has been associated with reductions in the number of LBW and small for gestational age (SGA) births, as well as a reduction in the number of preterm births among mothers who were underweight in both meta-analysis and a randomized control trial in Bangladesh. Recently in Dhaka, Bangladesh national anaemia consultation workshop was held, which also recommended changing the formulation from IFA only to a multi-micronutrient supplement for pregnant women and to scale up providing children with MNPs.

Objectives:

The study will be conducted in two phases. The specific objectives are;

Phase I:

  1. To conduct a comprehensive situation analysis to identify gaps in the existing maternal nutrition service delivery and coverage of maternal nutrition interventions
  2. To conduct a formative research to inform design of a demonstration programme improving maternal nutrition service delivery through public health ANC platforms Phase II:
  3. To implement a two parallel arm superiority community based cluster randomized controlled trial (cRCT) to assess whether implementation of the demonstration programme improves coverage and quality of nutrition service delivery through public health ANC platforms

Methods:

During phase I,a comprehensive situation analysis and a formative research will be conducted to inform the design of a demonstration programme improving maternal nutrition service delivery through public health ANC platforms. The study will employ a quantitative approach for comprehensive situation analysis involving health facility assessment, health care provider interviews, ANC observation, exit interviews of the women receiving ANC and household hold survey. The situation analysis will enable the investigators to identify the gaps of in terms of coverage and quality of maternal nutrition services through public health ANC platforms, knowledge, attitude and practices of the health care providers and pregnant women regarding maternal nutrition. A formative research will be conducted to inform the design of the demonstration programme. Demonstration programme will be designed based on the findings from the baseline situation analysis and formative research. During Phase II, a two parallel arm superiority community based cluster randomized control trial (cRCT) will be implemented to assess whether implementation of the demonstration programme improves coverage and quality of Nutrition services through public health ANC platforms. Unit of randomization will be unions. A total of 40 unions will be selected from two districts and paired based on principle component analysis (PCA) score. PCA will take into consideration coverage of ANC and IFA and socio-demographics characteristics (literacy rate, provision of pure drinking water, sanitation facilities). Later each of the pair will be randomized into either intervention or comparison arm. Cross sectional surveys will be conducted to assess coverage of key maternal health and nutrition indicators. Additionally a cohort of pregnant women from intervention and comparison facilities will be followed to measure the change in quality of nutrition service delivery and consumption of 100+ MMS tablets during pregnancy.

Being tested
Strengthening coverage and quality of nutrition services during ANC
Keywords
Maternal nutrition, Antenatal care, Randomized control trial, Multiple micro-nutrient supplementation, Bangladesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strengthening coverage and quality of nutrition services during ANCOther

    Intervention clusters will receive inputs both at facility level and community level. The supply side inputs will include efforts for improving facility readiness, quality of nutrition services during ANC, multiple micronutrient supplementation(MMS) and strengthening monitoring and supervision for ANC. On the other hand, community mobilization interventions will be carried out for demand creation. All public health facilities providing ANC services in the intervention area will be included; Union Health \& Family Welfare Center, Community Clinic and Satellite Clinic.

Study groups in NCT04559711
Study groupRoleWhat they receive
Intervention armExperimentalStrengthening coverage and quality of nutrition services including MMS during ANC
Receives: Other: Strengthening coverage and quality of nutrition services during ANC
Comparison armNo interventionExisting provision of nutrition services during ANC.

What is being measured

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

  1. Changes in the coverage of 100+ MMS supplementation among recently delivered women who received 4 ANC from the baseline to the end of the project in the intervention and the comparison areas

    Change in the proportion of pregnant women received at least 4 ANCs and consumed 100+ MMS supplementation in their last pregnancy from baseline to the end of the project in intervention and comparison areas

    Measured: Baseline (0 months) and end of project (18 months)

Secondary outcomes (4)
  1. Change in the quality of nutrition services during ANC (4 ANC MMS/IFA, weight gain monitoring and dietary counseling) from the baseline to the end of the project in the intervention and the comparison areas

    Change in the proportion of recently delivered women attended at least 4 ANCs and received three maternal nutrition services (MMS/IFA, weight gain monitoring and dietary counseling) from the baseline to the end of the project in the intervention and the comparison areas

    Measured: Baseline (0 months) and end of project(18 months)

  2. Change in the coverage of 4+ ANC from the baseline to the end of the project in the intervention and the comparison areas

    Change in the proportion of recently delivered women who received at least 4 ANC in their last pregnancy from the baseline to the end of the project in the intervention and the comparison areas

    Measured: Baseline (0 months) and end of project(18 months)

  3. Change in the coverage of nutrition counselling from the baseline to the end of the project in the intervention and the comparison areas

    Change in the proportion of recently delivered women who received nutrition counselling (diet, supplement \& lifestyle) in their last pregnancy from the baseline to the end of the project in the intervention and the comparison areas

    Measured: Baseline (0 months) and end of project(18 months)

  4. Change in the coverage of weight monitoring from the baseline to the end of the project in the intervention and the comparison areas

    Change in the proportion of recently delivered women who received at least 4 ANC and whose weight was recorded in the ANC card/ register for all four ANCs in their last pregnancy from the baseline to the end of the project in the intervention and the comparison areas

    Measured: Baseline (0 months) and end of project(18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel arm superiority community based cluster randomized controlled trial
Masking
None (open label)
Enrolment
2,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559711
Sponsor's protocol ID
PR-19124
Status last verified
Feb 2022
First submitted
6 Sep 2020
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Strengthening coverage and quality of nutrition services during ANC in people with Maternal Nutritional Deficiency During Childbirth, 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 2 inclusion and 1 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 7 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 Sk Masum Billah, MPH (+61484192204, billah@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the coverage of 100+ MMS supplementation among recently delivered women who received 4 ANC from the baseline to the end of the project in the intervention and the comparison areas (time frame: Baseline (0 months) and end of project (18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Apr 2022.

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