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.