Adherence, MedicationMAMANNCT05312242

Introduction of MMS to Antenatal Care in Bamako, Mali

A study testing United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS and Iron Folic Acid Supplement in people with Adherence, Medication, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Adherence, Medication
What is being tested?: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS and Iron Folic Acid Supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 486 participants
Where: 1 siteMali
Study dates: 10 Feb 2022to 15 Apr 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

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Presenting for first ANC visit.
Pregnant, as confirmed by at least one of the following:
Uterine examination
Urine human chorionic gonadotropin (HCG)
Ultrasound
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.

Who cannot join

Sample Group 1: Pregnant Women
Potential supplementation trial participants who meet any of the following criteria will be excluded from the study:
At time of enrollment, evidence of gestational age greater than 26 0/7 weeks, using one or more of the following methods: a) Uterine examination, b) First day of last normal menstrual period, and c) Ultrasound
As determined by the site investigator, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder, or infectious disease. Note: examples of uncontrolled conditions include but are not limited to the following: HIV not virally suppressed, COVID-19 infection, symptomatic malaria infection.
Has any other condition that, in the opinion of the site investigator, would preclude verbal informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
At time of enrollment, any known condition requiring routine antenatal care to take place at a location other than the study site CSCOM, e.g., Rh- negative status.

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At enrollment, reports either of the following: a) Participation in any research study involving drugs, vaccines, or medical devices during the current pregnancy, b) Expected to participate in other research studies involving drugs, vaccines, or medical devices for the duration of study participation
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.

Trial locations and contacts

1 site in 1 country.

Mali1 site

JPIEGO Mali
Bamako

Other trials in Mali

About this study

Official title: Introduction of Multiple Micronutrient Supplementation to Antenatal Care in Bamako, Mali

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

Read the detailed 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:

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

Conditions: Adherence, Medication
Being tested: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS, Iron Folic Acid Supplement
Keywords: Multiple Micronutrient Supplements (MMS), Adherence, Acceptability, Implementation Research, Antenatal Care
Medical subject headings: Medication Adherence

What participants receive

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

United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMSDietary supplement
Also called novel counseling strategies
Introduction of UNIMMAP MMS along with novel counseling strategies to increase acceptability and adherence to prenatal supplementation
Iron Folic Acid SupplementDietary supplement
Standard of Care Intervention

Study groups in NCT05312242
Study group	Role	What they receive
IFA + Standard of Care	Active comparator	Iron and Folic Acid (IFA) tablets dispensed 30 tablets at a time + standard of care [Represents standard of care comparison] Receives: Dietary Supplement: Iron Folic Acid Supplement
MMS 30 + novel counseling	Experimental	MMS dispensed 30 tablets at a time (MMS 30) with novel counseling Receives: Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS
MMS 180 + novel counseling	Experimental	MMS dispensed 180 tablets at a time (MMS 30) with novel counseling Receives: Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS

What is being measured

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

Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: 4 weeks post-enrollment (ANC-2)
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Adherence to the Antenatal Supplement Intervention (pill count)
Adherence assessment (pill count report)
Measured: Postnatal visit (6 weeks after delivery of infant)
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: 4 weeks post-enrollment (ANC-2)
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Adherence to Antenatal Supplement Intervention (self report)
Interviewer administered retrospective self report
Measured: Postnatal visit (6 weeks after delivery of infant)

Secondary outcomes (22)

Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: At 4 weeks post-enrollment (ANC-2)
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Acceptability of Antenatal Supplement (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal supplement to be acceptable.
Measured: Postnatal visit (6 weeks after delivery of infant)
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable.
Measured: At 4 weeks post-enrollment (ANC-2)
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable. Perceptions of midwives, pharmacists, and family members on counseling acceptability.
Measured: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Acceptability of Antenatal Counseling (i.e., pregnant women)
Proportion of ANC clients (i.e., pregnant women) who find the antenatal counseling to be acceptable.
Measured: Postnatal visit (6 weeks after delivery of infant)
Acceptability of Antenatal Supplement (i.e., midwives) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Proportion of midwives who find the antenatal supplement to be acceptable.
Measured: Within 2 months of study completion
Acceptability of Antenatal Supplement (i.e., pharmacists) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Proportion of pharmacists who find the antenatal supplement to be acceptable.
Measured: Within 2 months of study completion
Acceptability of Antenatal Supplement (i.e., family members) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Proportion of family members of ANC clients who find the antenatal supplement to be acceptable.
Measured: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., midwives) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Proportion of midwives who find the antenatal counseling to be acceptable.
Measured: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., pharmacists) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Proportion of pharmacists who find the antenatal counseling to be acceptable.
Measured: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., family members) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Proportion of family members of ANC clients who find the antenatal counseling to be acceptable.
Measured: Within 2 months of study completion

Timeline

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

10 Feb 202215 Apr 2023

First posted5 Apr 2022
Study start10 Feb 2022
Primary completion15 Apr 2023
Study completion15 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Adherence, MedicationStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC
Masking: None (open label)
Enrolment: 486 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05312242
Sponsor's protocol ID: IRB00017475
Acronym: MAMAN
Status last verified: Feb 2023
First submitted: 27 Jan 2022
Last updated: 1 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After data collection and analysis, Johns Hopkins Biostatistics Center (JHBC) and Johns Hopkins University (JHU) investigators will de-identify the data. The de-identified data will be shared with Research Triangle Institute (RTI) who is responsible for managing access to the shared data from all partners across the Gates ANC-PNC research collaborative, of which Jhpiego is a partner. This data will be collected and stored through the Synapse platform. The data will not be individually identifiable. The investigators will also adhere to JHBC's data sharing policies.

Publications

Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.
PubMed 31134643
Engle-Stone R, Kumordzie SM, Meinzen-Dick L, Vosti SA. Replacing iron-folic acid with multiple micronutrient supplements among pregnant women in Bangladesh and Burkina Faso: costs, impacts, and cost-effectiveness. Ann N Y Acad Sci. 2019 May;1444(1):35-51. doi: 10.1111/nyas.14132. Epub 2019 May 27.
PubMed 31134641
Demographic Health Survey Mali 2018. https://link.edgepilot.com/s/58ae5387/4L1KP3pdmU6VyyFqGxSdsQ?u=https://dhsprogram.com/methodology/survey/survey-display-517.cfm
Institut National de la Statistique - INSTAT, Cellule de Planification et de Statistique Secteur Santé-Développement Social et Promotion de la Famille CPS/SS-DS-PF et ICF. 2019. Enquête Démographique et de Santé au Mali 2018.Bamako, Mali et Rockville, Maryland, USA : INSTAT, CPS/SS-DS-PF et ICF.
Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.
PubMed 30873598
Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.
PubMed 29025632
WHO antenatal care recommendations for a positive pregnancy experience: Nutritional interventions update: Multiple micronutrient supplements during pregnancy [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK560384/
PubMed 32783435
United Nations Interagency Group for Child Mortality Estimation. Level and trend in child mortality report. 2017
Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.
PubMed 26584737

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Introduction of Multiple Micronutrient Supplementation to Antenatal Care in Bamako, Mali
ClinicalTrials.gov ID: NCT05312242
Acronym / sponsor ID: MAMAN / IRB00017475
Conditions: Adherence, Medication
Keywords: Multiple Micronutrient Supplements (MMS), Adherence, Acceptability, Implementation Research, Antenatal Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 486 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: Jhpiego, Bill and Melinda Gates Foundation, Center for Vaccine Development - Mali
Study start: 10 Feb 2022 (actual)
Primary completion: 15 Apr 2023 (actual)
Study completion: 15 Apr 2023 (actual)
First posted: 5 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC

Arm	Type	Receives
IFA + Standard of Care	Active comparator	Dietary Supplement: Iron Folic Acid SupplementIron and Folic Acid (IFA) tablets dispensed 30 tablets at a time + standard of care [Represents standard of care comparison]
MMS 30 + novel counseling	Experimental	Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMSMMS dispensed 30 tablets at a time (MMS 30) with novel counseling
MMS 180 + novel counseling	Experimental	Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMSMMS dispensed 180 tablets at a time (MMS 30) with novel counseling

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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.

Key exclusion criteria (13 listed)

Sample Group 1: Pregnant Women
Potential supplementation trial participants who meet any of the following criteria will be excluded from the study:
At time of enrollment, evidence of gestational age greater than 26 0/7 weeks, using one or more of the following methods: a) Uterine examination, b) First day of last normal menstrual period, and c) Ultrasound
As determined by the site investigator, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder, or infectious disease. Note: examples of uncontrolled conditions include but are not limited to the following: HIV not virally suppressed, COVID-19 infection, symptomatic malaria infection.
Has any other condition that, in the opinion of the site investigator, would preclude verbal informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMSAlso: novel counseling strategiesIntroduction of UNIMMAP MMS along with novel counseling strategies to increase acceptability and adherence to prenatal supplementation	Dietary supplement	MMS 180 + novel counseling, MMS 30 + novel counseling
Iron Folic Acid SupplementStandard of Care Intervention	Dietary supplement	IFA + Standard of Care

Primary outcome

Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: 4 weeks post-enrollment (ANC-2)
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Adherence assessment (pill count report)
Adherence to the Antenatal Supplement Intervention (pill count)
Time frame: Postnatal visit (6 weeks after delivery of infant)
Adherence assessment (pill count report)
Adherence to Antenatal Supplement Intervention (self report)
Time frame: 4 weeks post-enrollment (ANC-2)
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Interviewer administered retrospective self report
Adherence to Antenatal Supplement Intervention (self report)
Time frame: Postnatal visit (6 weeks after delivery of infant)
Interviewer administered retrospective self report

22 secondary outcomes

Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: At 4 weeks post-enrollment (ANC-2)
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Acceptability of Antenatal Supplement (i.e., pregnant women)
Time frame: Postnatal visit (6 weeks after delivery of infant)
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: At 4 weeks post-enrollment (ANC-2)
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
Acceptability of Antenatal Counseling (i.e., pregnant women)
Time frame: Postnatal visit (6 weeks after delivery of infant)
Acceptability of Antenatal Supplement (i.e., midwives) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion
Acceptability of Antenatal Supplement (i.e., pharmacists) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion
Acceptability of Antenatal Supplement (i.e., family members) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., midwives) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., pharmacists) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion
Acceptability of Antenatal Counseling (i.e., family members) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
Time frame: Within 2 months of study completion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Background: PubMed 31134643Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.
Background: PubMed 31134641Engle-Stone R, Kumordzie SM, Meinzen-Dick L, Vosti SA. Replacing iron-folic acid with multiple micronutrient supplements among pregnant women in Bangladesh and Burkina Faso: costs, impacts, and cost-effectiveness. Ann N Y Acad Sci. 2019 May;1444(1):35-51. doi: 10.1111/nyas.14132. Epub 2019 May 27.
BackgroundDemographic Health Survey Mali 2018. https://link.edgepilot.com/s/58ae5387/4L1KP3pdmU6VyyFqGxSdsQ?u=https://dhsprogram.com/methodology/survey/survey-display-517.cfm
BackgroundInstitut National de la Statistique - INSTAT, Cellule de Planification et de Statistique Secteur Santé-Développement Social et Promotion de la Famille CPS/SS-DS-PF et ICF. 2019. Enquête Démographique et de Santé au Mali 2018.Bamako, Mali et Rockville, Maryland, USA : INSTAT, CPS/SS-DS-PF et ICF.
Background: PubMed 30873598Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.
Background: PubMed 29025632Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.
Background: PubMed 32783435WHO antenatal care recommendations for a positive pregnancy experience: Nutritional interventions update: Multiple micronutrient supplements during pregnancy [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK560384/
BackgroundUnited Nations Interagency Group for Child Mortality Estimation. Level and trend in child mortality report. 2017
Background: PubMed 26584737Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.
Individual participant dataSharing planned: Yes. After data collection and analysis, Johns Hopkins Biostatistics Center (JHBC) and Johns Hopkins University (JHU) investigators will de-identify the data. The de-identified data will be shared with Research Triangle Institute (RTI) who is responsible for managing access to the shared data from all partners across the Gates ANC-PNC research collaborative, of which Jhpiego is a partner. This data will be collected and stored through the Synapse platform. The data will not be individually identifiable. The investigators will also adhere to JHBC's data sharing policies.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristen M Hurley, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

Lisa Noguchi, PhD study director

Jhpiego

Samba Sow, MD study director

Center for Vaccine Development - Mali

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 inclusion and 13 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: finished, as of the sponsor's last update on 1 May 2023. 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 Mali. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to the Antenatal Supplement Intervention (pill count) (time frame: 4 weeks post-enrollment (ANC-2)). The study lists 16 primary outcomes in all. 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 NCT05312242, which also lists 9 linked publications.

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 1 May 2023.