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Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) to improve maternal and neonatal health outcomes. MMS likely provides additional antenatal benefits over IFA supplementation alone. The Cambodian government, in partnership with Helen Keller International, is piloting MMS implementation in Takeo Province, which will inform nationwide scale-up of MMS.
Study Purpose: The Takeo implementation must be evaluated to understand context-specific implementation of MMS and health system readiness for scale-up. This study assesses system readiness through four domains from the Intervention Scalability Assessment Tool (ISAT): (1) fidelity and adaptation, (2) reach and acceptability, (3) delivery setting and workforce capacity, and (4) implementation infrastructure.
Population: The pilot involves transitioning to MMS from IFA across all 86 health centers, all 6 referral hospitals, and the provincial hospital in Takeo province. This study includes pregnant women receiving antenatal care, antenatal healthcare providers and facilities, and hospital managers in Takeo. The study also includes national governing bodies for MMS delivery.
Methods: This mixed-methods study uses ISAT as a framework for developing data collection methods. Sampling strategies emphasize urban and rural representation across all operational districts in Takeo and diverse stakeholder perspectives at multiple levels of the health system. Data collection includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focus group discussions (FGD) with health centre providers | 15 FGD (5 individuals each) | ||
| Key informant interviews with hospital managers | 17 hospital managers | ||
| Surveys with pregnant individuals who are consuming MMS | 630 pregnant individuals consuming MMS |
| |
| Focus group discussion (FGD) with national-level stakeholders in Cambodia | 1 FGD with 5 national-level stakeholders in Cambodia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple micronutrient supplement (MMS) for pregnancy | Dietary Supplement | Standard of care MMS during pregnancy (180 tablets total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perspectives on the transition to MMS | 12 FGD with health care providers | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Additional resources needed for successful MMS delivery | 12 FGD with health care providers | 4 months |
| Provider adherence to MMS delivery guidelines | 12 FGD with health care providers |
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For the cohort of pregnant individuals consuming MMS:
Inclusion Criteria:
Exclusion Criteria:
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A total of 630 individuals will be enrolled in the pregnancy cohort regardless of gestational age to evaluate acceptability and adherence patterns across different pregnancy stages and reflect the real-world setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Sokchea Program Manager, Helen Keller International, MD | Contact | +855 023 213 217 | MSokchea@hki.org | |
| Vannary Hun, MPH | Contact | +855 12 612 912 | vhun@hki.org |
| Name | Affiliation | Role |
|---|---|---|
| Hou Kroeun, MPH | Helen Keller International | Study Director |
| Crystal Karakochuk, PHD | University of British Columbia | Principal Investigator |
| Mai Hoang, MPH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeo province | Recruiting | Phnom Penh | Cambodia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2026 | Feb 3, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 4 months |
| Adherence of pregnant individuals to MMS supplementation | Adherence, %, of the total 180 tablets prescribed | 6 months |
| Perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery | FGD with hospital managers (key informant interviews) | 4 months |
| National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up | FGD with national-level stakeholders | 4 months |
| Quantification of any burden on providers and resource gaps to deliver MMS | Workload assessment surveys among the 15 FGD with health center providers | 4 months |
| Helen Keller International |
| Study Director |