BMJ Open (Dec 2022)

Study protocol: ‘a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India’

  • Manish Kumar,
  • Lakshmanan Jeyaseelan,
  • Ruby Angeline Pricilla,
  • Anuja Abraham,
  • Thenmozhi Mani,
  • Benjamin Jeyanth Ross,
  • Grace Mano R,
  • Suja Kurian,
  • Santosh Joseph Benjamin,
  • Swati Rathore,
  • Hilda Yenuberi,
  • Shanti dani Minz,
  • Reeta Vijayaselvi,
  • Annie Prasanthi,
  • Sunil George Abraham,
  • Emily Divya Ebenezer,
  • Anne George,
  • Rohin Mittal,
  • Jiji Elizabeth Mathews,
  • R Grace Mano

DOI
https://doi.org/10.1136/bmjopen-2022-063497
Journal volume & issue
Vol. 12, no. 12

Abstract

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Introduction In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care.Methods and analysis A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal careEthics and dissemination The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published.Trial registration number CTRI/2022/03/041343.