Assessing the Adherence to Iron and Folic Acid vs. Multiple Micronutrient Supplements During Pregnancy: A Cluster Randomized Non-Inferiority Trial in Cambodia
Notice bibliographique
Résumé
Objectives: Guidelines in Cambodia recommend iron and folic acid (IFA) supplementation during pregnancy. However, recent research has proven the superiority of multiple micronutrient supplementation (MMS) over IFA to reduce the risk of maternal anemia and adverse birth outcomes. The Cambodian Ministry of Health has expressed strong interest to transition from IFA to MMS during pregnancy but are seeking evidence in the Cambodian context to rigorously inform this policy change. Our primary objective was to assess adherence to MMS vs. IFA supplementation during pregnancy in Cambodia, as one of the first steps. Methods: We conducted a cluster-randomized non-inferiority trial across 48 health centers in Kampong Thom province. A total of 1,546 pregnant women were recruited at their first antenatal care visit and randomized to one of three arms at the health center-level: 1. IFA for 90 days (IFA-90, n=515), the current standard of care. 2. MMS for 180 days via one 180 tablet bottle (MMS-180, n=516). 3. MMS for 180 days via two 90-tablet bottles (MMS-90, n=515). The primary outcome was the non-inferiority of adherence rates to MMS-180 (180 days) compared to IFA-90 (90 days), assessed by tablet counts. Mixed-effects linear regression models were used to estimate the mean difference (95% CI) in adherence rates, controlling for health centers (clusters) and using an “a priori’ non-inferiority margin of 15%. Results: Overall, 87% of women completed the trial, with similar rates across IFA-90, MMS-180 and MMS-90 groups (89%, 88%, and 86% respectively). At enrollment, mean±SD age of women was 28±6 years and gestational age was 8±3 weeks. Overall, mean (95%CI) adherence rates groups were 91% (90, 92), 95% (94, 96), and 95% (94, 96), respectively; adherence was higher in both MMS groups as compared to IFA-90 (P< 0.001). The adjusted mean (95%CI) difference in adherence rates between MMS-180 and IFA-90 groups was 3.5% (1.3, 5.6), and between MMS-180 and MMS-90 groups was 0.3% (-2.5, 1.9). Conclusions: Adherence to MMS-180 during pregnancy was non-inferior to IFA-90; in fact, MMS-180 showed superiority to IFA-90. Adherence rates in the MMS groups did not differ when tablets were distributed via one vs. two bottles. These findings support the policy change for the use of MMS during pregnancy in Cambodia. Funding Sources: Vitamin Angel Alliance.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
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score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
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