You are here

Article Text

Article menu

Download PDFPDF

XML
Epidemiology
Protocol
Gestational route to healthy birth (GaRBH): protocol for an Indian prospective cohort study
  1. Vipin Gupta1,
  2. Ruchi Saxena2,
  3. Gagandeep Kaur Walia3,
  4. Tripti Agarwal3,
  5. Harsh Vats1,
  6. Warwick Dunn4,
  7. Caroline Relton5,
  8. Ulla Sovio6,
  9. Aris Papageorghiou7,
  10. George Davey Smith5,
  11. Rajesh Khadgawat8,
  12. Mohinder Pal Sachdeva1
  1. 1 Department of Anthropology, University of Delhi, Delhi, India
  2. 2 Department of Obstetrics and Gynaecology, Sardar Patel Medical College, Bikaner, Rajasthan, India
  3. 3 Public Health Foundation of India, New Delhi, India
  4. 4 School of Biosciences, Phenome Centre Birmingham and Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
  5. 5 MRC Integrative Epidemiology Unit and Bristol Medical School, University of Bristol, Bristol, UK
  6. 6 Obstetrics and Gyneacology, University of Cambridge, Cambridge, UK
  7. 7 Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, United Kingdom
  8. 8 All India Institute of Medical Sciences, New Delhi, India
  1. Correspondence to Dr Vipin Gupta; udaiig{at}gmail.com

Abstract

Introduction Pregnancy is characterised by a high rate of metabolic shifts from early to late phases of gestation in order to meet the raised physiological and metabolic needs. This change in levels of metabolites is influenced by gestational weight gain (GWG), which is an important characteristic of healthy pregnancy. Inadequate/excessive GWG has short-term and long-term implications on maternal and child health. Exploration of gestational metabolism is required for understanding the quantitative changes in metabolite levels during the course of pregnancy. Therefore, our aim is to study trimester-specific variation in levels of metabolites in relation to GWG and its influence on fetal growth and newborn anthropometric traits at birth.

Methods and analysis A prospective longitudinal study is planned (start date: February 2018; end date: March 2023) on pregnant women that are being recruited in the first trimester and followed in subsequent trimesters and at the time of delivery (total 3 follow-ups). The study is being conducted in a hospital located in Bikaner district (66% rural population), Rajasthan, India. The estimated sample size is of 1000 mother-offspring pairs. Information on gynaecological and obstetric history, socioeconomic position, diet, physical activity, tobacco and alcohol consumption, depression, anthropometric measurements and blood samples is being collected for metabolic assays in each trimester using standardised methods. Mixed effects regression models will be used to assess the role of gestational weight in influencing metabolite levels in each trimester. The association of maternal levels of metabolites with fetal growth, offspring’s weight and body composition at birth will be investigated using regression modelling.

Ethics and dissemination The study has been approved by the ethics committees of the Department of Anthropology, University of Delhi and Sardar Patel Medical College, Rajasthan. We are taking written informed consent after discussing the various aspects of the study with the participants in the local language.

  • birth cohort
  • india
  • metabolomics in pregnancy
  • foetal growth
  • epidemiology and developmental origin

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2018-025395

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • VG, RS and GKW contributed equally.

    • Contributors VG conceived the study concept with the help of GDS. VG developed the funding proposal, applied for funding and initiated the writing of the protocol paper. VG, GKW and MPS developed the study tools and procedures. VG, RS, RK, MPS and GKW coordinated the implementation and running of the study. GDS has advised in developing the study protocols and quality control and assurances. WD has provided expert opinion on metabolomic data generation and quality control. AP has provided expert opinion on ultrasound measures. GDS, CR, US, WD and VG have contributed to the statistical analysis plan and data interpretation. VG, RS, GKW, RK, TA and HV contributed to data collection and field management. All authors contributed in the revision and approval of the final version of the manuscript.

    • Funding This study has been supported by Wellcome/DBT India Alliance, Hyderabad, India, ’Intermediate' fellowship award to Vipin Gupta (grant reference: IA/CPHI/16/1/502623). ATP is supported by the Oxford Partnership Comprehensive Biomedical Research Centre with funding from the NIHR Biomedical Research Centres funding scheme.

    • Competing interests None declared.

    • Ethics approval The study has been approved by the ethics committees of the Department of Anthropology, University of Delhi and Sardar Patel Medical College, Bikaner, Rajasthan.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.