1 R GM, et al. BMJ Open 2022;12:e063497. doi:10.1136/bmjopen-2022-063497 Open access Study protocol: ‘a large cohort study of postnatal events in a not-for-proft referral centre in Vellore, South India’ Grace Mano R, 1 Ruby Angeline Pricilla, 2 Suja Kurian, 3 Santosh Joseph Benjamin, 1 Swati Rathore, 4 Hilda Yenuberi, 1 Shanti dani Minz, 5 Manish Kumar, 6 Benjamin Jeyanth Ross, 6 Reeta Vijayaselvi, 1 Anuja Abraham, 1 Annie Prasanthi, 1 Thenmozhi Mani , 7 Sunil George Abraham, 2 Emily Divya Ebenezer, 1 Anne George, 8 Rohin Mittal, 9 Lakshmanan Jeyaseelan , 10,11 Jiji Elizabeth Mathews , 1 The PoNTiS Collaborative Group To cite: R GM, Pricilla RA, Kurian S, et al. Study protocol: ‘a large cohort study of postnatal events in a not- for-proft referral centre in Vellore, South India’. BMJ Open 2022;12:e063497. doi:10.1136/ bmjopen-2022-063497 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2022-063497). Received 05 April 2022 Accepted 21 November 2022 For numbered affliations see end of article. Correspondence to Dr Jiji Elizabeth Mathews; og5@cmcvellore.ac.in Protocol © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Introduction In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that infuence 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 care Ethics 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. INTRODUCTION The focus of the global health community has shifted from coverage to quality of care, from antenatal and intrapartum care to postnatal care. There has been an impressive improve- ment in maternal and new born mortality with the completion of the millennium develop- ment goals. However, in this era of sustainable development goals, emphasis on morbidity and quality of care has taken centre stage. Very little is known about the postpartum phase in our subcontinent. Substantial improvements in antenatal and intrapartum care have made research into this phase of care important for the improvement of the well-being of both mother and child. There is an urgent need to comprehend details of maternal medical, physical and mental health, newborn health, social support system and barriers to breast feeding, contraception and sexual activity, all of which are interlinked for optimal health- care. This protocol aims to address this lacuna. Outcomes of a cohort of about 14 000 deliveries per year for 18 years in a tertiary centre in south India have been published in the British Journal of Obstetrics and Gyne- cology in June 2019. 1 The overall caesarean section rate is close to 33% with an overall perinatal mortality of 16 per 1000. This study aims to identify postnatal concerns in the year after delivery. STRENGTH AND LIMITATIONS OF THIS STUDY ⇒ This is a large cohort study of all women who deliv- ered in a referral centre in a 1-year period. ⇒ Baseline information at delivery and postnatal peri- od is collected prospectively. ⇒ Follow-up of postnatal women and their offspring will be done at 3, 9 and 18 months. ⇒ Unscheduled visits of women or offspring to a care provider and the indications for these visits will be collated. ⇒ Follow-up will be done through a physical visit and/ or telephonically. on October 13, 2023 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2022-063497 on 19 December 2022. Downloaded from