Status:
COMPLETED
Introduction of MMS to Antenatal Care in Bamako, Mali
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Jhpiego
Bill and Melinda Gates Foundation
Conditions:
Adherence, Medication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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,...
Eligibility Criteria
Inclusion
- 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:
- 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.
- EXCLUSION CRITERIA:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2023
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT05312242
Start Date
February 10 2022
End Date
April 15 2023
Last Update
May 1 2023
Active Locations (1)
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1
JPIEGO Mali
Bamako, Mali