DOI: 10.5061/dryad.wh70rxwz3
title: Data from: A large cohort study of postnatal events over 18 months in a not-for-profit referral centre in Vellore, South India

description: To assess maternal medical conditions, physical and surgical ailments,
 contraceptive use and barriers to its use, maternal mental health,
 neonatal health, breastfeeding practices, and available social support in
 the postpartum period. The study design is a prospective cohort
 study, set in a large tertiary care centre. 12245 women who delivered
 after 22 weeks of gestation. Three pre-specified exposures, namely mode of
 delivery, presence of significant risk factors, and preterm delivery
 within the cohort, were used to identify potential groups of women who
 would need additional support. The primary outcome was the number of
 unscheduled visits by the mother or child and the indications for these
 visits. The secondary outcomes in mothers included unhealed wound sites,
 anaemia, an increase in BMI by &gt;3, persistent high blood pressure,
 pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal
 pain, abnormal maternal mental health, breast-related issues, and barriers
 to breastfeeding, contraceptive use, and sexual activity. Only 2% of women
 and children were lost to follow-up. Nine women and 75 babies
 died.  The majority of infant deaths were related to serious
 congenital diseases. Unscheduled visits to the health facility were seen
 in 44% of the cohort, most commonly for upper respiratory infections and
 fever in the mother and baby. 41 mothers and 741 infants needed admission
 to the hospital. Hospitalisation was more common in those with risk
 factors or preterm delivery. High blood pressure was seen in 3 to 4 % and
 anaemia in 4% of the cohort. Wound infection was seen in 3 to 4 % and
 urinary incontinence in 2% of women. Wound infection was more common with
 instrumental delivery. Bowel incontinence was rare. A fourth of the cohort
 had musculoskeletal pain, especially back pain, which was more common
 after caesarean delivery. Only 5.5% of the cohort had unsatisfactory
 mental health. The family APGAR of the cohort was 9/10, and 95% belonged
 to the middle-income group. 2.6% of neonates had delayed milestones, and
 this was more common in the group with risk factors and preterm delivery.
 Health care utilization was mainly for minor complaints. Re-admissions
 were rare, as intrapartum and immediate postpartum care were optimal.
 Women who delivered by caesarean section or delivered a preterm child
 needed additional support in the postpartum phase. The implementation of
 formal telephonic support 24 hours a day in birthing facilities should be
 explored in the future.
description: This large cohort study was executed based on the published
 protocol. The design, setting, participants, exposure, details of study
 implementation<sup>,</sup> and strategies for tracing women
 for follow-up have also been detailed in the Protocol. This study was
 funded by the Indian Council of Medical Research (ICMR). Postpartum women
 were recruited after approval from the Institutional Review Board (Number
 12178 dated 24th June 2020). This trial was registered with
 CTRI/2022/03/041343 (CTRLink:https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjYyMDE=&Enc=&userName= ). In this cohort study, all women who delivered after 22 completed weeks of gestation in the department were recruited after informed written consent. All details of baseline data at delivery and in the immediate postpartum period were captured prospectively. They were followed up for 18 months at three contact points, one of which was face-to-face by trained research personnel. The Primary and Secondary outcome measures: The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.  The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in BMI, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity. <strong>Definitions of some significant variables assessed as outcomes:</strong> Socio-economic status (SES) was assessed as low, middle and high SES using the Kuppuswamy socio-economic status scale 2021. Family APGAR score of 1 to 10 was used to identify dysfunctional families. Low scores signified dysfunctional families. Scheduled visit and special schedule visit (SSV): During the period of our study, all women with no complications were advised to report at around 14 weeks, and this was termed a scheduled postnatal visit. Special scheduling was when the caregiver advised the woman of an earlier visit due to obstetric, medical, surgical, intrapartum or postpartum complications either for the mother or baby. Unscheduled visit: Any visit before the scheduled or special visit was termed as an unscheduled visit. Mental health assessment: a)      Risk factor Assessment (RFA) and NICE Questionnaire were used to identify post-natal women with mental illness at baseline assessment. b)      Edinburgh postnatal depression scale (EPDS) and Perceived stress scale (PSS) were used to diagnose depression.   <strong>Care at delivery in this tertiary centre:</strong> The labour ward is managed by residents with 2-3 years of experience in the domain of obstetrics and gynaecology. Nurse-midwives only provide additional support but are not primarily responsible for intrapartum care. A consultant with a minimum of 8 years’ experience is also present on-site, 24 hours a day. Details of some aspects of the intrapartum care of this setting have been published. Around 18% of women have an instrumental delivery with Forceps used 80% of the time, and Vacuum delivery for the rest. <strong>Care in the immediate post-partum period and before discharge:</strong> Women are discharged only when they are ambulant, afebrile and have normal bowel and bladder movements. The baby is discharged only when optimal breastfeeding is possible and when there is no loss of weight or hyperbilirubinemia. Counselling for wound care is given before discharge. The department follows a strict antibiotic policy, with prophylactic use only for Caesarean sections and complications of the 3<sup>rd</sup> and 4<sup>th</sup> stages. Antibiotics are started after a blood culture for any patient at the second spike of fever. <strong>Care at Discharge</strong> The advice at discharge in our centre is typically informal, and there is no checklist followed. For the duration of this study, we followed some protocols. We advised women to come for a health check only at 12-14 weeks along with the child’s immunisation schedule, as opposed to the usual practice of assessing them at 6 weeks. Baseline details of intrapartum and immediate postpartum events were collated using the postnatal health assessment questionnaire (PNHAQ) using the RedCap software system. This covered important domains of demography, socioeconomic status, family support and social framework. All women had a Risk factor assessment (RFA) and the NICE questionnaire completed for mental health assessment as described in the protocol for the duration of the study. This protocol was not practised routinely in the centre. For the study period, we formalised the indication for special scheduled visits (SSV) (Refer to appendix), and we also provided each woman with a card listing warning signs for the baby and mother (Refer to appendix). This was also not part of the routine care in the department. They were informed that an in-person contact was required at 12-14 weeks for their scheduled postpartum care visit, and there would also be a telephonic assessment at 9 and 18 months. <strong>Patient and Public Involvement Statement:</strong> This study did not involve patients and the public in the design and conduct of the study. The consenting process, the detailed capture of the demography of families, the mental health assessment and the three follow-up visits were opportunities for unprecedented engagement with the postnatal women and their families. The assessments were done only at the place and times that was convenient for the women. Privacy was ensured at all times during the interviews. The engagement with over 12,000 women at three time points was an opportunity to assess all possible challenges, complications and satisfaction of the women and members of their immediate and extended family in the postnatal care of the woman and her offspring. Thus, this cohort study has been able to capture satisfaction of care through the comprehensive assessment of all outcomes in mother and child, reinforcing public and patient partnership. The outcomes of the study will be disseminated in various appropriate forums after its publication. <strong>Protocol deviation:</strong> The protocol was changed to at least one face-to-face contact during any one of the 3 contacts. This was done as poor compliance was noticed at the face-to-face 14-week visit; we also recognized a difficulty in achieving home visits with the available staff. Details of actual timings of follow-up contact have been captured in the appendix. Thus, the timing of actual follow-up visits, especially of the first contact, was delayed and the original time points of 3,9 and 18 months had to be changed to phases of 6 months. <strong>Data Collection:</strong> The assessment at these contact points was done by health care providers (HCP) /research staff with a nursing or allied health background, with a minimum of 5-10 years of experience in collecting data for research projects. Trained field workers were involved in contacting women and children, checking weight, blood pressure and hemoglobulin using a point-of-care test.   Good clinical practice certification was ensured for all research staff involved with the study. Interviews at each contact were conducted by a different HCP as a strategy to prevent underreporting of events. Privacy was ensured at all times during the interview. The interviews facilitated the completion of the postnatal health assessment questionnaire (PNHAQ) using the RedCap software system.  In one of these visits at the face-to-face assessment, the mother’s weight, blood pressure, haemoglobin and general well-being were checked. Blood pressure was checked using an automated instrument (Omron model HEM 8712-Omron Health Care-India Private Limited-Vietnam). Weight was checked with a Nova weighing machine (Model PS 126-Health Sense Bangalore, Karnataka). These machines were regularly checked for accuracy. Women who attended the parent hospital, had hemoglobin checked with an automated spectrometric analyser and those who had an in-person visit at home had spot hemoglobin estimation using a haemoglobinometer (HaemCue HB 301 Analyser, which was factory calibrated against an international reference). Anaemia was diagnosed when hemoglobin was less than 10gm/dl. Postnatal hypertension was diagnosed when the BP exceeded 140/90 mmHg. Maternal mental health assessment was done using the Edinburgh postnatal depression scale (EPDS) and Perceived Stress Scale (PSS) as mentioned in the protocol. Similarly, only at one of the contacts, the baby’s weight and development delay were measured using the Trivandrum Developmental Screening Chart<sup>16</sup>.^^ The^^ details of the baby were also filled in PNHAQ. The women who were lost to follow-up were traced with a minimum of 10 phone calls in order to ensure optimal tracking. The Statistical Analysis plan, as described in the protocol was executed. The progression of mothers and infants through the study duration, in terms of number eligible, consented, and followed-up, are illustrated using a flow diagram, including reasons for exclusions. (Refer Figure 1) Frequency of dropouts are presented with reasons when available. Baseline characteristics, as well as demographic data, are presented descriptively. <strong>Descriptive and univariate summary</strong> All variables were analysed as per pre-defined exposure groups, namely mode of delivery (Cesarean vs vaginal), presence or absence of high-risk factors, and gestation at delivery (preterm vs term). Within each set of comparisons of pre-defined exposure groups, continuous variables were summarised using Mean and Standard Deviations (SD) for normally distributed data, or medians and interquartile ranges for skewed data. Categorical variables were described using absolute frequencies with percentages. <strong>Primary outcome analysis</strong> Frequency of unscheduled events (and other primary outcome variables) was calculated and compared between exposure groups. The chi-square or Fisher’s exact tests and unadjusted Odds Ratios (OR) were used to describe the association between unscheduled events with exposure groups. Continuous outcomes were compared between exposure groups using independent two-sample t-tests or Mann-Whitney tests, as appropriate. Statistical analyses were performed using Stata v11 (StataCorp, Tx, US). Only outcomes that were prespecified as the Main comparison of interest (M) and Secondary comparison of interest (s) according to the relevance for the exposure pair, were analyzed as described in the protocol. Prespecified sub group analysis was performed for instrumental versus normal delivery, very preterm &lt;32 weeks versus 32-37 weeks and NICE questionnaire assessment &gt;50% at discharge versus &lt; 50%. Missing data for contact 1 was less than 0.01 percent; for contact 2 was less than 0.36 percent and for contact 3, less than 0.29 percent.  <strong>Role of the funding source:</strong> The funder of this study, the Indian Council of Medical Research (ICMR), had no role in the design, data collection, analysis or interpretation of the study.
description: # Data from: A large cohort study of postnatal events over 18 months in a
 not-for-profit referral centre in Vellore, South India Dataset DOI:
 [10.5061/dryad.wh70rxwz3](10.5061/dryad.wh70rxwz3) ## Description of the
 data and file structure The assessment at these contact points was done by
 health care providers (HCP) /research staff with a nursing or allied
 health background, with a minimum of 5-10 years of experience in
 collecting data for research projects. Trained field workers were involved
 in contacting women and children, checking weight, blood pressure^,^ and
 hemoglobin using a point-of-care test.   Good clinical practice
 certification was ensured for all research staff involved with the
 study. Interviews at each contact were conducted by a different HCP as a
 strategy to prevent underreporting of events. Privacy was ensured at all
 times during the interview. The interviews facilitated the completion of
 the postnatal health assessment questionnaire (PNHAQ) using the RedCap
 software system.  In one of these visits at the face-to-face assessment,
 the mother’s weight, blood pressure, haemoglobin, and general well-being
 were checked. Blood pressure was checked using an automated instrument
 (Omron model HEM 8712-Omron Health Care-India Private Limited-Vietnam).
 Weight was checked with a Nova weighing machine (Model PS 126-Health Sense
 Bangalore, Karnataka). These machines were regularly checked for accuracy.
 Women who attended the parent hospita, had hemoglobin checked with an
 automated spectrometric analyser, and those who had an in-person visit at
 home had spot hemoglobin estimation using a haemoglobinometer (HaemCue HB
 301 Analyser, which was factory calibrated against an international
 reference). Anaemia was diagnosed when the hemoglobin was less than
 10gm/dl. Postnatal hypertension was diagnosed when the BP exceeded 140/90
 mmHg. Maternal mental health assessment was done using the Edinburgh
 postnatal depression scale (EPDS) and Perceived Stress Scale (PSS) as
 mentioned in the protocol. Similarly, only at one of the contacts, the
 baby’s weight and development delay were measured using the Trivandrum
 Developmental Screening Chart. The details of the baby were also filled in
 PNHAQ. The women who were lost to follow-up were traced with a minimum of
 10 phone calls in order to ensure optimal tracking. ### Files and
 variables PoNTiS_Study(1).csv: Contains assessment response for the below
 mentioned file. PoNTiS_Study(2).csv: This list contains the standard
 components of a postnatal assessment form. It gathers information on the
 mother’s medical, obstetric, surgical, psychological, and socioeconomic
 background, as well as details about delivery, complications, and
 recovery. It also includes assessments of the newborn’s health,
 breastfeeding, contraception plans, mental health screening, and follow-up
 visits. Overall, it helps evaluate the wellbeing of both mother and baby
 during the postnatal period. Code/software: RedCap Software ## Human
 subjects data Human subject data have been de-identified in accordance
 with applicable regulations. All identifiable information has been removed
 or anonymised to protect participant privacy.