Outcomes of interventions in neonatal sepsis: A systematic review of qualitative research.

BACKGROUND: While a systematic review exists detailing neonatal sepsis outcomes from clinical trials, there remains an absence of a qualitative systematic review capturing the perspectives of key stakeholders. OBJECTIVES: Our aim is to identify outcomes from qualitative research on any intervention to prevent or improve the outcomes of neonatal sepsis that are important to parents, other family members, healthcare providers, policymakers, and researchers as a part of the development of a core outcome set (COS) for neonatal sepsis. SEARCH STRATEGY: A literature search was carried out using MEDLINE, EMBASE, CINAHL, and PsycInfo databases. SELECTION CRITERIA: Publications describing qualitative data relating to neonatal sepsis outcomes were included. DATA COLLECTION AND ANALYSIS: Drawing on the concepts of thematic synthesis, texts related to outcomes were coded and grouped. These outcomes were then mapped to the domain headings of an existing model. MAIN RESULTS: Out of 6777 records screened, six studies were included. Overall, 19 outcomes were extracted from the included studies. The most frequently reported outcomes were those in the domains related to parents, healthcare workers and individual organ systemas such as gastrointestinal system. The remaining outcomes were classified under the headings of general outcomes, miscellaneous outcomes, survival, and infection. CONCLUSIONS: The outcomes identified in this review are different from those reported in neonatal sepsis clinical trials, thus highlighting the importance of incorporating qualitative studies into COS development to encapsulate all relevant stakeholders' perspectives.

Multiple electrolyte derangements among perioperative women with obstructed labour in eastern Uganda: A cross-sectional study.

There is a dearth of information on the patterns of electrolyte derangements among perioperative women with obstructed labour. We measured the levels and patterns of electrolyte derangements among women with obstructed labour in eastern Uganda. This was a secondary analysis of data for 389 patients with obstructed labour, diagnosed by either an obstetrician or medical officer on duty between July 2018 and June 2019. Five milliliters of venous blood was drawn from the antecubital fossa under an aseptic procedure for electrolytes and complete blood analyses. The primary outcome was the prevalence of electrolyte derangements, defined as values outside the normal ranges: Potassium 3.3-5.1 mmol/L, Sodium 130-148 mmol/L, Chloride 97-109 mmol/L, Magnesium 0.55-1.10 mmol/L, Calcium (Total) 2.05-2.42 mmol/L, and Bicarbonate 20-24 mmol/L. The most prevalent electrolyte derangement was hypobicarbonatemia [85.8% (334/389)], followed by hypocalcaemia [29.1% (113/389)], then hyponatremia [18% (70/389)]. Hyperchloraemia [4.1% (16/389)], hyperbicarbonatemia [3.1% (12/389)], hypercalcaemia [2.8% (11/389)] and hypermagnesemia [2.8% (11/389)] were seen in a minority of the study participants. A total of 209/389 (53.7%) of the participants had multiple electrolyte derangements. Women who used herbal medicines had 1.6 times the odds of having multiple electrolyte derangements as those who did not use herbal medicines [Adjusted Odds Ratio (AOR): 1.6; 95% Confidence Interval (CI): (1.0-2.5)]. Having multiple electrolyte derangements was associated with perinatal death although this estimate was not precise [AOR 2.1; 95% CI: (0.9-4.7)]. Women with obstructed labour in the perioperative period have multiple electrolyte derangements. Use of herbal medicines in labour was associated with having multiple electrolyte derangements. We recommend routine assessment of electrolytes prior to surgery in patients with obstructed labour.

Decision to delivery interval for emergency caesarean section in Eastern Uganda: A cross-sectional study.

INTRODUCTION: The decision to delivery interval is a key indicator of the quality of obstetric care. This study assessed the decision to delivery interval for emergency cesarean sections and factors associated with delay. METHODS: We conducted a cross-sectional study between October 2022 and December 2022 in the labor ward at Mbale regional referral hospital. Our primary outcome variable was the decision to delivery interval defined as the time interval in minutes from the decision to perform the emergency caesarean section to delivery of the baby. We used an observer checklist and interviewer administered questionnaire to collect data. Stata version 14.0 (StataCorp; College Station, TX, USA) was used to analyze the data. RESULTS: We enrolled 352 participants; the mean age was 25.9 years and standard deviation (SD) ±5.9 years. The median (interquartile range) decision to delivery interval was 110 minutes (80 to 145). Only 7/352 (2.0%) participants had a decision to delivery time interval of ≤30 minutes. More than three quarters 281 /352 (79.8%) had a decision to delivery interval of greater than 75 minutes. Emergency cesarean section done by intern doctors compared to specialists [Adjusted Prevalence Ratio (aPR): 1.26; 95% CI: (1.09-1.45)] was associated with a prolonged decision to delivery interval. CONCLUSION: The average decision to delivery interval was almost 2 hours. Delays were mostly due to health system challenges. We recommend routine monitoring of decision to delivery interval as an indicator of the quality of obstetric care.

Protocol for the development of a core outcome set for neonatal sepsis (NESCOS).

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.

Incidence and determinants of perinatal mortality among women with obstructed labour in eastern Uganda: a prospective cohort study.

BACKGROUND: In Uganda, the incidence and determinants of perinatal death in obstructed labour are not well documented. We determined the incidence and determinants of perinatal mortality among women with obstructed labour in Eastern Uganda. METHODS: Between July 2018 and September 2019, 584 with obstructed labour were recruited and followed up to the 7th day postnatal. Information on maternal characteristics, obstetric factors and laboratory parameters was collected. Each patient received the standard perioperative care. We used a generalized linear model for the Poisson family, with a log link and robust variance estimation to determine the association between the exposure variables and perinatal death. RESULTS: Of the 623 women diagnosed with obstructed labour, 584 met the eligibility criteria. There were 24 fresh still births (FSB) and 32 early neonatal deaths (ENND) giving an FSB rate of 43.8 (95% CI 28.3-64.4) deaths per 1000 total births; early neonatal death rate of 58.4 (95% CI 40.3-81.4) deaths per 1000 and an overall perinatal mortality rate of 102.2 (95% CI 79.4-130.6) deaths in the first 7 days of life. A mother being referred in active labour adjusted risk ratio of 2.84 (95% CI: 1.35-5.96) and having high blood lactate levels at recruitment adjusted risk ratio 2.71 (95% CI: 1.26-4.24) were the determinants of perinatal deaths. CONCLUSIONS: The incidence of perinatal death was four times the regional and national average. Babies to women referred in active labour and those with high maternal blood lactate were more likely to die.

Effect of pre-operative bicarbonate infusion on maternal and perinatal outcomes among women with obstructed labour in Mbale hospital: A double blind randomized controlled trial.

INTRODUCTION: Oral bicarbonate solution is known to improve both maternal and perinatal outcomes among women with abnormal labour (dystocia). Its effectiveness and safety among women with obstructed labour is not known. OBJECTIVE: To determine the effect and safety of a single-dose preoperative infusion of sodium bicarbonate on maternal and fetal blood lactate and clinical outcomes among women with obstructed labour (OL) in Mbale hospital. METHODS: We conducted a double blind, randomised controlled trial from July 2018 to September 2019. The participants were women with OL at term (≥37 weeks gestation), carrying a singleton pregnancy with no other obstetric emergency, medical comorbidity or laboratory derangements. INTERVENTION: A total of 477 women with OL were randomized to receive 50ml of 8.4% sodium bicarbonate (238 women) or 50 mL of 0.9% sodium chloride (239 women). In both the intervention and controls arms, each participant was preoperatively given a single dose intravenous bolus. Every participant received 1.5 L of normal saline in one hour as part of standard preoperative care. OUTCOME MEASURES: Our primary outcome was the mean difference in maternal venous blood lactate at one hour between the two arms. The secondary outcomes were umbilical cord blood lactate levels at birth, neonatal sepsis and early neonatal death upto 7 days postnatal, as well as the side effects of sodium bicarbonate, primary postpartum hemorrhage, maternal sepsis and mortality at 14 days postpartum. RESULTS: The median maternal venous lactate was 6.4 (IQR 3.3-12.3) in the intervention and 7.5 (IQR 4.0-15.8) in the control group, with a statistically non-significant median difference of 1.2 mmol/L; p-value = 0.087. Vargha and Delaney effect size was 0.46 (95% CI 0.40-0.51) implying very little if any effect at all. CONCLUSION: The 4.2g of preoperative intravenous sodium bicarbonate was safe but made little or no difference on blood lactate levels. TRIAL REGISTRATION: PACTR201805003364421.

Maternal and newborn health priority setting partnership in rural Uganda in association with the James Lind Alliance: a study protocol.

BACKGROUND: Maternal and newborn deaths and ill health are relatively common in low income countries, but can adequately be addressed through locally, collaboratively designed, and responsive research. This has the potential to enable the affected women, their families and health workers themselves to explore 'why maternal and newborn adverse outcomes continue to occur. The objectives of the study include; To work with seldom heard groups of mothers, their families, and health workers to identify unanswered research questions for maternal and newborn health in villages and health facilities in rural UgandaTo establish locally responsive research questions for maternal and newborn health that could be prioritised together with the public in UgandaTo support the case for locally responsive research in maternal and newborn health by the ministry of health, academic researchers and funding bodies in Uganda. METHODS: The present study will follow the James Lind Alliance (JLA) Priority Setting Partnership (PSP) methodology. The project was initiated by an academic research group and will be managed by a research team at the Sanyu Africa Research Institute on a day to day basis. A steering group with a separate lay mothers' group and partners' group (individuals or organisations with interest in maternal and newborn health) will be recruited. The PSP will be initiated by launch meetings, then a face-to-face initial survey for the collection of raw unanswered questions; followed by data collation. A face-to-face interim prioritisation survey will then be performed to choose questions before the three separate final prioritisation workshops.The PSP will involve many participants from an illiterate, non-internet population in rural eastern Uganda, but all with an interest in strategies to avert maternal and newborn deaths or morbidities in rural eastern Uganda. This includes local rural women, their families, health and social workers, and relevant local groups or organisations.We will generate a top 10 list of maternal and newborn health research priorities from a group with no prior experience in setting a research agenda in rural eastern Uganda. DISCUSSION: The current protocol elaborates the JLA methods for application with a new topic and in a new setting translating the JLA principles not just into the local language, but into a rural, vulnerable, illiterate, and non-internet population in Uganda. The face-to-face human interaction is powerful in eliciting what exactly matters to individuals in this particular context as opposed to online surveys.This will be the first time that mothers and lay public with current or previous experience of maternal or neonatal adverse outcomes will have the opportunity to identify and prioritise research questions that matter to them in Uganda. We will be able to compare how the public would prioritise maternal health research questions over newborn health in this setting.