Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia (NCT06225791) | Clinical Trial Compass
CompletedNot Applicable
Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia
Indonesia5,384 participantsStarted 2023-12-25
Plain-language summary
The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:
* Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence.
* Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
* Enrolled in ANC 1 through government health facilities.
* Received MMS at ANC 1
* Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
* Consent provided to participate in the study.
Exclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
* PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,)
* PW planning to move outside study district during study period.
Inclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
* Enrolled in ANC 1 through government health facilities.
* Received MMS at ANC 1
* Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
* Consent provided to participate in qualitative component of study.
* Received MMS for at least 3 months.
* Attended \> 2 ANC visits.
* \< 4 weeks post-partum
Exclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
* Enrolled in Sample 1
* Women who are more than 4 weeks postpartum.
Inclusion Criteria for 180 healthcare providers participating in focus group discussions (FGDs) (sample group 3)
* Government health workers who provide ANC services (e.g., midwives, general practitioners, and nutritionists)
* Government health facility management staff (e.g.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MMS Adherence (amount)
Timeframe: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
2
MMS Adherence (frequency)
Timeframe: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
Trial details
NCT IDNCT06225791
SponsorJohns Hopkins Bloomberg School of Public Health