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Smart Discharges for Mom & Baby 2.0: A cohort study to develop prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads
Borealis
Wiens, Matthew O; Kenya-Mugisha, Nathan; Namala, Angella; Tagoola, Abner; Bebell, Lisa; Pillay, Yashodani; Ansermino, J Mark; Kissoon, Niranjan; Payne, Beth A; Vidlern, Marianne; Christoffersen-Deb, Astrid; Lavoie, Pascal; Bone, Jeffrey — 2023-05-15 <br /><strong>Dataset Description:</strong> This dataset contains materials from the Smart Discharges for Mom & Baby parent study within the <a href = "https://bcchr.ca/smart-discharges">Smart Discharges</a> program of research. Materials include the parent study ethics protocol and associated documents. See the Metadata section below for links to related publications and datasets.<br /> <br /><strong>Background:</strong> In low-income country settings, the first six weeks after birth remain a critical period of vulnerability for both mother and newborn. Despite recommendations for routine post-discharge follow-up, few mothers and newborns receive guideline recommended care during this period. Prediction modelling of post-delivery outcomes has the potential to improve outcomes for both mother and newborn by identifying high-risk dyads, improving risk communication, and facilitating a patient-centered approach to postnatal care. <br /> <br /><strong>Methods:</strong> This is a mixed-methods study to explore and map the current postnatal discharge processes in Uganda.We will conduct an observational cohort study (Phase I) to develop and internally validate our risk score and aim to recruit 7,000 mother and newborn dyads from Jinja Regional Referral Hospital and Mbarara Regional Referral Hospital. We will also engage with patients, families, and health workers through patient journey mapping and focus group discussions (Phases II-IV) to identify barriers and facilitators to inform the development of an evidence- and risk-based bundle of interventions to improve postnatal care (PNC) for dyads. <br /> <br />The primary outcome is maternal and/or neonatal death or need for re-admission within six weeks of birth. <br /> <br />Secondary outcomes include:<br /> 1. Post-natal care visits during the 6-week post-discharge period <br /> 2. Post-discharge health seeking practices for mothers/newborns during the 6-week post-discharge period<br /> 3. Causes of readmission/mortality among those who experience such outcomes, based on verbal autopsies and admission symptom/diagnosis questionnaires.<br /> <br /><strong>Data Collection Methods:</strong> All data will be collected at the point of care using encrypted study tablets. These data will be uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses will systematically collect data on clinical, social and demographic variables. Following discharge, field officers will contact mothers at 6-weeks post-discharge, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for participants who had died following discharge.<br /> <br /> Direct observation and interviews will be conducted on a sub-set of participants to collect process outcomes and barriers and facilitators to the patient's journey. FGDs will be digitally recorded, transcribed verbatim in the language spoken during the recording and analyzed for emerging themes. <br /> <br /><strong>Ethics Declaration:</strong> Ethics approvals have been obtained from the Makerere University School of Public Health (MakSPH) Institutional Review Board (SPH-2021-177), the Uganda National Council of Science and Technology (UNCST) in Uganda (HS2174ES) and the University of British Columbia in Canada (H21-03709). This study has been registered at clinicaltrials.gov (NCT05730387).<br /> <br /><strong>Associated datasets:</strong> <br /> Pending publication <br /><strong>NOTE for restricted files:</strong> If you are not yet a CoLab member, please complete our <a href = "https://rc.bcchr.ca/redcap/surveys/?s=EDCYL7AC79">membership application survey</a> to gain access to restricted files within 2 business days. <br />Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on <a href = "https://www.bcchr.ca/pediatric-sepsis-data-colab">this page</a> under "collaborate with the pediatric sepsis colab."
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Smart Discharges for Mom & Baby 1.0: Targeted follow-up after facility delivery with accurate predictions of neonatal and maternal morbidity or mortality
Borealis
Pillay, Yashodani; Ngonzi, Joseph; Nguyen, Vuong; Payne, Beth A.; Komugisha, Clare; Twinomujuni, Annet H.; Vidler, Marianne; Lavoie, Pascal M.; Bebell, Lisa M.; Christoffersen-Deb, Astrid; Kenya-Mugisha, Nathan; Kissoon, Niranjan; Ansermino, J Mark; Wiens, Matthew O — 2023-11-09 <br/><strong>Background:</strong> The first six weeks following delivery bear the most significant and persistent burden of under-5 and maternal death, and severe neonatal and maternal morbidity. Efforts are currently underway to improve outcomes immediately following births at health facilities for both mothers and newborns. However, care following facility discharge presents significant challenges and accounts for a high proportion of maternal and neonatal death and morbidity. The objective of this study is to develop a clinical risk prediction model using maternal and infant characteristics collected at the time of hospital discharge following a facility delivery to predict maternal or neonatal death or major morbidity within six weeks of birth. A secondary objective is to characterize the epidemiology of post-discharge mortality and morbidity for women and their infants after facility delivery. <br/> <br /><strong>Methods:</strong> We will recruit a cohort of 3200 maternal and infant pairs after delivery at Mbarara Regional Referral Hospital to develop the risk model. This study involves prospective recruitment and data collection prior to discharge and final follow-up at six weeks postpartum for both mom and baby. Initial data collection will be completed by study research nurses as a prospective chart review and time of discharge patient assessment. Data collection will include maternal socio-demographics variables, clinical condition during admission, details of delivery and co-morbid conditions and maternal and infant vital signs at hospital discharge. Six-week follow up will be completed in person at the facility or through telephone follow-up to capture any maternal or infant adverse outcomes, including details of any re-admission to hospital, occurring after the initial discharge.<br /> <br /><strong>Ethics Declaration:</strong> Institutional review boards at the University of British Columbia (H18-02523), the Mbarara University of Science and Technology (14/09-18), and the Uganda National Council for Science and Technology (SS 4853) approved the study.<br /> <br /><strong>NOTE for restricted files:</strong> If you are not yet a CoLab member, please complete our <a href = "https://rc.bcchr.ca/redcap/surveys/?s=EDCYL7AC79">membership application survey</a> to gain access to restricted files within 2 business days. <br />Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator at <a href = mailto:sepsiscolab@bccchr.ca>sepsiscolab@bcchr.ca</a> or visit our <a href = "https://wfpiccs.org/pediatric-sepsis-colab/">website</a>.
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The epidemiology and risk factors for postnatal complications among postpartum women and neonates in Southwestern Uganda: a prospective cohort study
Borealis
Pillay,Yashodani; Ngonzi, Joseph; Nguyen, Vuong; Payne, Beth A; Komugisha, Clare; Twinomujuni, Annet H.; Vidler, Marianne; Lavoie, Pascal M.; Bebell, Lisa M.; Christoffersen-Deb, Astrid; Kenya-Mugisha, Nathan; Kissoon, Niranjan; Ansermino, J Mark; Wiens, Matthew O — 2024-08-14 <br/><strong>Background:</strong> Sub-Saharan Africa accounts for two-thirds of the global burden of maternal and newborn deaths. Adverse outcomes among postpartum women and newborns occurring in the first six weeks of life are often related, though data co-examining patients are limited. This study is an exploratory analysis describing the epidemiology of postnatal complications among postpartum women and newborns following facility birth and discharge in Mbarara, Uganda.<br/> <br /><strong>Methods: </strong> This single-site prospective cohort observational study enrolled postpartum women following facility-based delivery. To capture health information about both the postpartum women and newborns, data was collected and categorized according to domains within the continuum of care including (1) social and demographic, (2) pregnancy history and antenatal care, (3) delivery, (4) maternal discharge, and (5) newborn discharge. The primary outcomes were readmission and mortality within the six-week postnatal period as defined by the WHO. Multivariable logistic regression was used to identify risk factors. <br /> <br /><strong>Findings: </strong> Among 2930 discharged dyads, 2.8% and 9.0% of women and newborns received three or more postnatal visits respectively. Readmission and deaths occurred among 108(3.6%) and 25(0.8%) newborns and in 80(2.7%) and 0(0%) women, respectively. Readmissions were related to sepsis/infection in 70(88%) women and 68(63%) newborns. Adjusted analysis found that caesarean delivery (OR:2.91; 95%CI:1.5–6.04), longer travel time to the facility (OR:1.54; 95%CI:1.24–1.91) and higher maternal heart rate at discharge (OR:1.02; 95%CI:1.00–1.01) were significantly associated with maternal readmission. Discharge taken on all patients including maternal haemoglobin (per g/dL) (OR:0.90; 95%CI:0.82–0.99), maternal symptoms (OR:1.76; 95%CI:1.02–2.91), newborn temperature (OR:1.66; 95%CI:1.28–2.13) and newborn heart rate at (OR:1.94; 95%CI:1.19–3.09) were risk factors among newborns. Readmission and death following delivery and discharge from healthcare facilities is still a problem in settings with low rates of postnatal care visits for both women and newborns. Strategies to identify vulnerable dyads and provide better access to follow-up care, are urgently required. <br /> <br /><strong>Data Collection Methods:</strong> This prospective cohort study aimed to enroll women presenting in labor at >28 weeks’ gestation who delivered liveborn infants and were routinely discharged together home with their infants. Following delivery, we obtained written consent to complete a structured questionnaire in-person and a follow-up questionnaire over the phone six weeks later. Specifically, following enrolment, research nurses prospectively collected study variables previously identified through two systematic reviews on risk factors for re-admission and mortality among postpartum women and infants, as well as through discussion with colleagues and other experts. Given the interactive health relationship between postpartum women and infants, variables were collected and categorized according to relevant time points across the continuum of care. A total of 86 variables were collected and broadly categorized into five domains: (1) social and demographic, (2) pregnancy history and antenatal care, (3) delivery, (4) maternal discharge, and (5) neonatal discharge (Table 4A-E). Apart from discharge measurements, we prioritized gathering data from the hospital medical record, followed by interviews with the postpartum women and finally confirmation with the medical team if there were discrepancies, missing information, or questions the postpartum woman was unable to answer. With respect to discharge measurements, we obtained and recorded clinical data for both mother and their newborns on every dyad discharged together from the hospital. Blood pressure was measured using a Welch Allyn Vital Signs Monitor 300 Series (Welch Allyn, New York, USA). Oxygen saturation (SpO2) and heart rate was measured using the Masimo iSpO2® (Masimo Corporation, California, USA) and respiratory rates were measured using the RRate Application. Maternal hematocrit was quantified using a microhematocrit centrifuge. Random blood glucose was measured on mother and newborn using the FreeStyle Optimum Xceed (Abbott Healthcare, Massachusetts, USA). Anthropometric data of infants (length, weight, mid-upper arm circumference (MUAC), head circumference) were also measured and recorded. All dyads received routine care during admission and were discharged at the discretion of their medical teams. Six weeks following discharge, women who were discharged with their newborns were contacted by phone to determine the status of the mother and newborn and timing and frequency of postnatal care visits. For children who died, the cause of death was collected, as reported by the caregiver (mother or other family member). In addition to vital status, details surrounding the timing, frequency and length of stay pertaining to readmissions and health seeking were also recorded. Data were collected and managed using Research Electronic Data Capture (REDCap) tools hosted at the BC Children’s Hospital Research Institute in Vancouver, Canada.<br /> <br /><strong>Data Processing Methods:</strong>The initial cleaned data file was created using R version 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria). Further processing to obtain the final dataset used for analysis including creating new columns, removing redundant columns, and removing duplicate data were also performed in R in the R scripts titled “MBEPI2024_DataManipulations_Code_SD.R” and “MBEPI2024_CombinedDatasetforOR_Code_SD.R” . All analyses were conducted using R version 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria)<br/> <br /><strong>Ethics Declaration:</strong> Institutional review boards at the University of British Columbia (H18-02523), the Mbarara University of Science and Technology (14/09-18), and the Uganda National Council for Science and Technology (SS 4853) approved the study.<br />

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(Author: Christoffersen-Deb, Astrid)

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