Introduction of MMS to Antenatal Care in Bamako, Mali

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2023-04-15

Brief Summary

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The aim of this implementation research is to compare how different implementation strategies influence the acceptability and adherence to antenatal supplement use in pregnancy.

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Detailed Description

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In the past several decades, the République du Mali (Mali) has achieved reductions in both maternal mortality ratio and neonatal mortality rate. However, with an estimated 562 maternal deaths per 100,000 live births and 65.8 infant deaths per 1,000 births, substantial changes to maternal child health services will likely need to be implemented to realize the benefits of universal healthcare for mothers and children and recover from the damaging impacts of colonialism and conflict. The prevalence of low birth weight (\<2.5 kg) among children whose birth weights are known is estimated to be approximately 16%, but is likely underestimated. The Malian decentralized health system places antenatal care (ANC) at Centre de Santé Communautaire (CSCOM), a type of community-based health center. Approximately 36% of women in Mali access ANC in the first trimester. Within the context of ANC, the current national policy in Mali recommends that pregnant women take daily IFA supplements that contain 60 mg of iron and 400 μg of folic acid starting at the first ANC contact and ending three months after delivery. However, recent DHS data indicates that coverage of iron for pregnant women for at least 90 days has remained sub-optimal, and may be decreasing, with only 28% of women taking iron tablets for at least 90 days during their last pregnancy.

While IFA supplements have been a component of the "gold standard" of antenatal nutritional care for decades, there is clear and consistent evidence from clinical trials that MMS provide additional benefits over IFA in reducing adverse pregnancy outcomes. As compared to IFA, MMS performs better in reducing the occurrence of small for gestational age (SGA), low birth weight (LBW), preterm birth, and stillbirth. MMS performs even better than IFA with respect to pregnancy outcomes and infant survival when used by pregnant women who are anemic or underweight. Further, MMS has been demonstrated to be safe, cost-effective, and possible to produce at price parity with IFA. In 2020, the WHO released updated ANC guidelines recommending the use of MMS containing iron and folic acid in the context of rigorous research, including implementation research (IR) to establish the impact of switching from IFA supplements to MMS, including evaluation of uptake, acceptability, adherence, and cost-effectiveness.

This implementation research study design will facilitate answering the following questions, all of which were deemed to be of importance when considering the potential switch from supplementation with iron and folic acid (IFA) to multiple micronutrient supplementation (MMS) in the Malian context:

1. How does adherence to antenatal supplement use compare across study arms?
2. How does acceptability of antenatal supplements compare across study arms for both ANC clients and midwives?
3. What level of acceptability is associated with a novel counseling package for MMS?
4. What is the cost-effectiveness of switching from IFA to MMS in the Malian context?

Conditions

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Adherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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IFA + Standard of Care

Iron and Folic Acid (IFA) tablets dispensed 30 tablets at a time + standard of care \[Represents standard of care comparison\]

Group Type ACTIVE_COMPARATOR