cRCT to Improve Maternal Nutrition Service Delivery During ANC

NCT04559711 | Unknown

• 1 other identifier: PR-19124
• Study Type: interventional
• Target: 2,520
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Maternal Nutritional Deficiency During Childbirth

Keywords

Maternal nutrition; Antenatal care; Randomized control trial; Multiple micro-nutrient supplementation; Bangladesh

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (4)

• 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

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

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

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

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

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

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

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

Study Arms (2)

Intervention arm

EXPERIMENTAL

Strengthening coverage and quality of nutrition services including MMS during ANC

Other: Strengthening coverage and quality of nutrition services during ANC

Comparison arm

NO INTERVENTION

Existing provision of nutrition services during ANC.

Interventions

Strengthening coverage and quality of nutrition services during ANC OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• UNICEF: collaborator
• Penn State University: collaborator
• Government of Bangladesh: collaborator
• World Bank: collaborator
• Sight and Life, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Bogra, Bangladesh

RECRUITING

Study Officials

• Sk Masum Billah, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sk Masum Billah, MPH

CONTACT

+61484192204; billah@icddrb.org

Nazia Binte Ali, MPH, MBBS

CONTACT

+8801751789769; nazia.ali@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arm superiority community based cluster randomized controlled trial

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 23, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-02

Locations

BA (1)