Ethical considerations
The Ethical clearance was obtained from the Ethics review committee of
Faculty of Medicine and Allied Sciences, Rajarata University of Sri
Lanka under ERC/2019/22 and approved on 15/08/2019. Written informed
consent was taken from all pregnant mothers to participate in this study
as well as to use routinely collected data for this research purpose.
The participants were informed that this research is conducted in
parallel with the routine maternal and child health service and any
“abnormality” will be reported to the health provider with the
participant’s consent. In addition, consent had been sought for use of
serum sample for screening of diabetes mellitus, liver biochemistry and
serum cholesterol level and any other future studies, that may require
baseline assessment of serum. Data was linked to the health records
using a classified code, so that the confidentiality of data secured.
Individual level data will not be presented in any form and summary data
was used in research publications and data dissemination.