Brabin, Bernard J; Gies, Sabine; Owens, Stephen; Claeys, Yves; D'Alessandro, Umberto; Tinto, Halidou; Brabin, Loretta; (2016) Perspectives on the design and methodology of periconceptional nutrient supplementation trials. Trials, 17 (1). 58-. ISSN 1745-6215 DOI: https://doi.org/10.1186/s13063-015-1124-0
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Abstract
Periconceptional supplementation could extend the period over which maternal and fetal nutrition is improved, but there are many challenges facing early-life intervention studies. Periconceptional trials differ from pregnancy supplementation trials, not only because of the very early or pre-gestational timing of nutrient exposure but also because they generate subsidiary information on participants who remain non-pregnant. The methodological challenges are more complex although, if well designed, they provide opportunities to evaluate concurrent hypotheses related to the health of non-pregnant women, especially nulliparous adolescents. This review examines the framework of published and ongoing randomised trial designs. Four cohorts typically arise from the periconceptional trial design--two of which are non-pregnant and two are pregnant--and this structure provides assessment options related to pre-pregnant, maternal, pregnancy and fetal outcomes. Conceptually the initial decision for single or micronutrient intervention is central--as is the choice of dosage and content--in order to establish a comparative framework across trials, improve standardisation, and facilitate interpretation of mechanistic hypotheses. Other trial features considered in the review include: measurement options for baseline and outcome assessments; adherence to long-term supplementation; sample size considerations in relation to duration of nutrient supplementation; cohort size for non-pregnant and pregnant cohorts as the latter is influenced by parity selection; integrating qualitative studies and data management issues. Emphasis is given to low resource settings where high infection rates and the possibility of nutrient-infection interactions may require appropriate safety monitoring. The focus is on pragmatic issues that may help investigators planning a periconceptional trial.
Item Type | Article |
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Keywords | Periconceptional, Pregnancy, Placenta, Iron, Folic acid, Micronutrients, Adherence, NEURAL-TUBE DEFECTS, FOLIC-ACID SUPPLEMENTATION, RANDOMIZED, CONTROLLED-TRIAL, MULTIPLE-MICRONUTRIENT SUPPLEMENTATION, FOR-GESTATIONAL-AGE, MOTHER-CHILD COHORT, LOW-BIRTH-WEIGHT, FETAL-GROWTH, 1ST TRIMESTER, IRON STATUS |
Faculty and Department | MRC Gambia > GM-Gambia Clinical Services/Comms |
PubMed ID | 26833080 |
ISI | 369139200001 |
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