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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.
Full description
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:
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Inclusion criteria
Sample Group 1: Pregnant Women
Potential supplementation trial participants must meet all the following criteria to be eligible for inclusion in the study:
Age 18 years or older at screening.
At time of enrollment, able and willing to comply with all study requirements and complete all study procedures.
Able and willing to provide verbal informed consent to be screened for and to take part in the study.
Intention to stay within study catchment area for study duration and willingness to give adequate locator information, as defined in site standard operating procedures (SOPs).
Presenting for first ANC visit.
Pregnant, as confirmed by at least one of the following:
Sample Group 2: Midwives
Midwives who participated in delivery of the intervention will be recruited from the six health center study sites. Inclusion criteria includes the provision of verbal informed consent.
Sample Group 3: Pharmacists
Pharmacists who participated in delivery of the intervention will be recruited from the six health center study sites. Inclusion criteria includes the provision of verbal informed consent.
Sample Group 4: Family Members
Family members (e.g., male partners and mothers/mothers-in-law) will be recruited based on participation of their female family member in the study protocol. Inclusion criteria includes the provision of verbal informed consent.
Exclusion criteria
Sample Group 1: Pregnant Women
Potential supplementation trial participants who meet any of the following criteria will be excluded from the study:
Sample Group 2: Midwives
Potential participants who do not provide verbal informed consent will not be included.
Sample Group 3: Pharmacists
Potential participants who do not provide verbal informed consent will not be included.
Sample Group 4: Family Members
Potential participants who do not provide verbal informed consent will not be included.
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486 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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