Abstract
Background: Prematurity and low birth weight is major causes of child morbidity and mortality with the greatest burden in Low and Middle income countries. Maternal under nutrition is a major risk factor for these adverse outcomes. The benefits of protein energy supplementation in pregnancy are controversial and have not been tested formally in Pakistan where under nutrition in women of conceptual age is highly prevalent. Methods: Open label parallel limb individually randomized controlled trial from September 2014 to March 2016 in two peri urban settings at Karachi, Pakistan. A total of 300 pregnant women with a BMI of ≤ 19.9 were randomly allocated either the intervention of daily energy dense biscuits or the control oil and flour from 14 weeks of gestation until delivery. Compliance was self-reported. The primary outcome was birth weight. Results: 125 women completed the study and 117 babies were analyzed in the intervention arm (6 neonatal deaths & 2 still births) while 123 women completed the study and 116 babies were analyzed in control group (3 neonatal deaths and 4 still births). Overall compliance with biscuits was 75.3 %. The mean birth weight in the intervention arm was 2768 (SD473 g) and control arm 2742 (SD + 473 g) with a non-significant difference of 26 g (95 % CI -95.27 - 151.33, (p=0.65). Conclusion: The provision of daily energy dense biscuits to poor undernourished pregnant women in urban Karachi did not increase birth weight.
Highlights
Low birth weight (LBW) either as a result of intrauterine growth restriction or prematurity is a major cause of perinatal mortality and adult cardiovascular and cognitive morbidity [1, 2]
We aimed to assess the effectiveness of high calorie dense food in the form of biscuits over a regular diet augmented by flour and oil in under nourished pregnant women (BMI ≤19.9) offered from 14 completed weeks of gestation until delivery.We hypothesized that offering energy dense biscuits rich in calories and micronutrients would enhance maternal and fetal weight gain in our setting and result in adherence to multiple micronutrient (MMN) supplementation which is difficult to achieve in the form of tablets
We found no significant increase in neonatal birth weight for term infants with supplementation of energy dense biscuits
Summary
Low birth weight (LBW) either as a result of intrauterine growth restriction or prematurity is a major cause of perinatal mortality and adult cardiovascular and cognitive morbidity [1, 2]. The burden of LBW is much greater in Low and Middle Income Countries (LMICs). About 20 million children are born with low birth weight, about 95 % in developing countries. The role of micronutrient supplementation has been extensively assessed by a number of high quality trials which have (largely) shown positive albeit small effects birth weight [7, 8]. The effect from protein energy supplementation in undernourished women in LMICs is more controversial. High protein intake during pregnancy has shown negative effect in some studies [9] and even isocaloric protein diet has no proven benefit to mother or infant[10]. Recent systematic review and meta-analysis of 7 trials ( 2,367 women) showed a that balanced proteinenergysupplementation significantly improved birth weight (d = 0.20, 95% confidence interval, 0.03-0.38, P = 0.02). There was, no effect on birth length or birth head circumference [11]
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