An interventional study of Multiple Micronutrient Supplement in Pregnancy Related, sponsored by University of Pennsylvania. Completed at 13 sites in Botswana. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.
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Exclusion Criteria:
Dietary Supplement: Multiple Micronutrient Supplement
Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,
Proportion with first supplement filled by MMS
Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom the first supplement filled during pregnancy is MMS. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
Time frame: 6-month intervention period
Implementation: Proportion for which MMS is filled
This outcome will be evaluated using data from clinic logbooks and by subtracting the number of supplements remaining in the clinic at the end of the study from the number of supplements provided to the clinic
Time frame: 6-month intervention period
Implementation: Proportion for which first and second supplement filled by MMS
Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom MMS is filled at the first and second antenatal visit. This outcome will be evaluated through linkage with the Tsepamo Study. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
Time frame: 6-month intervention period
Implementation: Feasibility
Feasibility of the intervention will be measured via qualitative pre- and post- intervention surveys among staff at the intervention clinics. Questions will be asked using a Likert scale ranging from completely disagree to completely agree. We will report the mean/median response for each question as well as the mean/median change in score between the pre and post surveys. As this is a qualitative measure there is no predefined minimum or maximum value.
Time frame: 8 months
Clinical: Number of Pregnant Women with an Adverse Birth Outcome
1\) Any adverse birth outcome, consisting of stillbirth, preterm birth, SGA, neonatal death (as well as individual birth outcomes) among those who deliver at one of the Tsepamo sites. . As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
Time frame: 6-months
Clinical: Weight Gain in Pregnancy
Weight gain in pregnancy among those who deliver at one of the Tsepamo sites. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
Time frame: 6-months
Clinical: Number of mothers diagnosed with Maternal Anemia
Number of mothers diagnosed with Anemia during the six month intervention or percentage of mothers diagnosed with anemia during 6 months of intervention compared to the percentage of mothers diagnosed with anemia in the 6 months prior to the intervention or 6 months after the interventions was completed.
Time frame: 6-months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Jan 2026, 18 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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