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.publishedVersio

Maternal and umbilical cord blood lactate for predicting perinatal death: a secondary analysis of data from a randomized controlled trial.

BackgroundIn high resource settings, lactate and pH levels measured from fetal scalp and umbilical cord blood are widely used as predictors of perinatal mortality. However, the same is not true in low resource settings, where much of perinatal mortality occurs. The scalability of this practice has been hindered by difficulty in collecting fetal scalp and umbilical blood sample. Little is known about the use of alternatives such as maternal blood, which is easier and safer to obtain. Therefore, we aimed to compare maternal and umbilical cord blood lactate levels for predicting perinatal deaths.MethodsThis was secondary analysis of data from a randomized controlled trial assessing the effect of sodium bicarbonate on maternal and perinatal outcomes among women with obstructed labour at Mbale regional referral hospital in Eastern Uganda. Lactate concentration in maternal capillary, myometrial, umbilical venous and arterial blood was measured at the bedside using a lactate Pro 2 device (Akray, Japan Shiga) upon diagnosis of obstructed labour. We constructed Receiver Operating Characteristic curves to compare the predictive ability of maternal and umbilical cord lactate and the optimal cutoffs calculated basing on the maximal Youden and Liu indices.ResultsPerinatal mortality risk was: 102.2 deaths per 1,000 live births: 95% CI (78.1-130.6). The areas under the ROC curves were 0.86 for umbilical arterial lactate, 0.71 for umbilical venous lactate, and 0.65 for myometrial lactate, 0.59 for maternal lactate baseline, and 0.65 at1hr after administration of bicarbonate. The optimal cutoffs for predicting perinatal death were 15 0.85 mmol/L for umbilical arterial lactate, 10.15mmol/L for umbilical venous lactate, 8.75mmol/L for myometrial lactate, and 3.95mmol/L for maternal lactate at recruitment and 7.35mmol/L after 1 h.ConclusionMaternal lactate was a poor predictor of perinatal death, but umbilical artery lactate has a high predictive value. There is need for future studies on the utility of amniotic fluid in predicting intrapartum perinatal deaths

IMCI and ETAT Integration at a Primary Healthcare Facility in Malawi:A Human Factors Approach

Abstract Background Integrated Management of Childhood Illness (IMCI) and Emergency Triage, Assessment and Treatment (ETAT) are guidelines developed by the World Health Organization to reach targets for reducing under-5 mortality. They were set out in the Millennium Development Goals. Each guideline was established separately so the purpose of this study was to understand how these systems have been integrated in a primary care setting and identify barriers and facilitators to this integration using a systems approach. Method Interviews were carried out with members of staff of different levels within a primary healthcare clinic in Malawi. Along with observations from the clinic this provided a well-rounded view of the running of the clinic. This data was then analysed using the SEIPS 2.0 work systems framework. The work system elements specified in this model were used to identify and categorise themes that influenced the clinic’s efficiency. Results A process map of the flow of patients through the clinic was created, showing the tasks undertaken and the interactions between staff and patients. In their interviews, staff identified several organisational elements that served as barriers to the implementation of care. They included workload, available resources, ineffective time management, delegation of roles and adaptation of care. In terms of the external environment there was a lack of clarity over the two sets of guidelines and how they were to be integrated which was a key barrier to the process. Under the heading of tools and technology a lack of guideline copies was identified as a barrier. However, the health passport system and other forms of recording were highlighted as being important facilitators. Other issues highlighted were the lack of transport provided, challenges regarding teamwork and attitudes of members of staff, patient factors such as their beliefs and regard for the care and education provided by the clinic. Conclusions This study provides the first information on the challenges and issues involved in combining IMCI and ETAT and identified a number of barriers. These barriers included a lack of resources, staff training and heavy workload. This provided areas to work on in order to improve implementation

Prevalence of and Factors Associated with Hypertension Among Adults on Dolutegravir-Based Antiretroviral Therapy in Uganda: A Cross Sectional Study

Ronald Kasoma Mutebi,1– 3 Andrew Weil Semulimi,1,4 John Mukisa,5 Martha Namusobya,1 Joy Christine Namirembe,3 Esther Alice Nalugga,1 Charles Batte,1 David Mukunya,6 Bruce Kirenga,1,7 Robert Kalyesubula,4 Pauline Byakika-Kibwika7 1Lung Institute, Department of Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda; 2Clinical Epidemiology Unit, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda; 3Department of Medicine, Mengo Hospital, Kampala, Uganda; 4Department of Physiology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda; 5Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Kampala, Uganda; 6Department of Community and Public Health, Faculty of Health Sciences, Busitema University, Mbale, Uganda; 7Department of Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, UgandaCorrespondence: Ronald Kasoma Mutebi, Department of Medicine, Mengo Hospital, PO BOX 7161, Kampala, Uganda, Email [email protected]: Dolutegravir-based anti-retroviral therapy (ART) regimens were rolled out as first line HIV treatment in Uganda due to their tolerability, efficacy and high resistance barrier to human immunodeficiency virus (HIV). They have however been associated with weight gain, dyslipidemia and hyperglycemia which are cardiometabolic risk factors of hypertension. We assessed the prevalence and factors associated with hypertension among adults on dolutegravir regimens.Methods: We conducted a cross-sectional study on 430 systematically sampled adults on dolutegravir-based ART for ≥ 6 months. Hypertension was defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg or history of use of antihypertensive agents.Results: The prevalence of hypertension was 27.2% (117 of 430 participants) [95% CI: 23.2– 31.6]. Majority were female (70.7%), the median age 42 [34, 50] years, with body mass index (BMI) ≥ 25 kg/m3 (59.6%) and median duration on DTG-based regimens of 28 [15, 33] months. Being male [aPR: 1.496, 95% CI: 1.122– 1.994, P = 0.006], age ≥ 45 years [aPR: 4.23, 95% CI: 2.206– 8.108, P < 0.001] and 35– 44 years [aPR: 2.455, 95% CI: 1.216– 4.947, P < 0.012] as compared with age < 35 years, BMI ≥ 25 kg/m3 [aPR: 1.489, 95% CI: 1.072– 2.067, P = 0.017] as compared with BMI < 25 kg/m3, duration on dolutegravir-based ART [aPR: 1.008, 95% CI: 1.001– 1.015, P = 0.037], family history of hypertension [aPR: 1.457, 95% CI: 1.064– 1.995, P = 0.019] and history of heart disease [aPR: 1.73, 95% CI: 1.205– 2.484, P = 0.003] were associated with hypertension.Conclusion: One in every four people with HIV (PWH) on dolutegravir-based ART has hypertension. We recommend the integration of hypertension management in the HIV treatment package and policies to improve existing supply chains for low cost and high-quality hypertension medications.Keywords: hypertension, dolutegravir, HI

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

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

BackgroundIn 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.MethodsBetween 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.ResultsOf 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.ConclusionsThe 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

High prevalence of non-dipping patterns among Black Africans with uncontrolled hypertension: a secondary analysis of the CREOLE trial.

BACKGROUND: Dipping of blood pressure (BP) at night is a normal physiological phenomenon. However, a non-dipping pattern is associated with hypertension mediated organ damage, secondary forms of hypertension and poorer long-term outcome. Identifying a non-dipping pattern may be useful in assessing risk, aiding the decision to investigate for secondary causes, initiating treatment, assisting decisions on choice and timing of antihypertensive therapy, and intensifying salt restriction. OBJECTIVES: To estimate the prevalence and factors associated with non-dipping pattern and determine the effect of 6 months of three antihypertensive regimens on the dipping pattern among Black African hypertensive patients. METHODS: This was a secondary analysis of the CREOLE Study which was a randomized, single blind, three-group trial conducted in 10 sites in 6 Sub-Saharan African countries. The participants were 721 Black African patients, aged between 30 and 79 years, with uncontrolled hypertension and a baseline 24-h ambulatory blood pressure monitoring (ABPM). Dipping was calculated from the average day and average night systolic blood pressure measures. RESULTS: The prevalence of non-dipping pattern was 78% (564 of 721). Factors that were independently associated with non-dipping were: serum sodium > 140 mmol/l (OR = 1.72, 95% CI 1.17-2.51, p-value 0.005), a higher office systolic BP (OR = 1.03, 95% CI 1.01-1.05, p-value 0.003) and a lower office diastolic BP (OR = 0.97, 95% CI 0.95-0.99, p-value 0.03). Treatment allocation did not change dipping status at 6 months (McNemar's Chi2 0.71, p-value 0.40). CONCLUSION: There was a high prevalence of non-dipping among Black Africans with uncontrolled hypertension. ABPM should be considered more routinely in Black Africans with uncontrolled hypertension, if resources permit, to help personalise therapy. Further research is needed to understand the mechanisms and causes of non-dipping pattern and if targeting night-time BP improves clinical outcomes. Trial registration ClinicalTrials.gov (NCT02742467)