Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial
Abstract
The negative synergy between poor nutritional status and infectious diseases is doubly detrimental in pregnancy. In Sierra Leone, maternal malnutrition is amongst the highest in the world, while maternal mortality is high at 1320/100,000 live births and stunting in under-five is 37.9%, ranked 110/132 worldwide. Maternal malnutrition has been associated with preterm birth, small-for-gestational age infants, and poor maternal outcomes. Infants born prematurely or small-for-gestational age experience higher mortality and are at risk for stunting and decreased cognitive performance. Nutritional interventions alone during pregnancy may not be as effective in the setting of increased inflammation from repeated infections. Interventions are needed to improve maternal outcomes and reduce stunting in this population. This will be a prospective, randomized, controlled clinical effectiveness trial of an improved supplementary food plus anti-infective therapies compared to standard therapy in malnourished pregnant women. Pregnant women will be randomized to receive a low water activity, ready-to-use supplementary food plus five anti-infective interventions or the standard of care which is 3.5 kg corn/ soy blended flour with 350 mL vegetabl...Continue Reading
Associated Clinical Trials
References
Albendazole therapy and reduced decline in haemoglobin concentration during pregnancy (Sierra Leone)
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