Milton W Musaba1,2,3, Julius N Wandabwa1, Grace Ndeezi3, Andrew D Weeks4, David Mukunya4,5,6,7, Paul Waako8, Victoria Nankabirwa5,6, Kenneth Tulya-Muhika Mugabe2, Daniel Semakula9, James K Tumwine3, Justus K Barageine10. 1. Department of Obstetrics and Gynaecology, Busitema University Faculty of Health Sciences, Mbale, Uganda. 2. Department of Obstetrics and Gynaecology, Mbale Regional Referral Hospital, Mbale, Uganda. 3. Department of Paediatrics and Child Health, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. 4. Sanyu Research Unit, University of Liverpool/Liverpool Women's Hospital, Liverpool, United Kingdom. 5. Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda. 6. Centre for Intervention Science and Maternal Child health (CISMAC), Centre for International Health, University of Bergen, Bergen, Norway. 7. Department of Public and Community Health, Busitema University Faculty of Health Sciences, Mbale, Uganda. 8. Department of Pharmacology and Therapeutics, Busitema University Faculty of Health Sciences, Mbale, Uganda. 9. Africa Centre for Systematic Reviews and Knowledge Translation, Makerere University College of Health Sciences, Kampala, Uganda. 10. Department of Obstetrics & Gynaecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Abstract
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.
RCT Entities:
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.
Authors: Milton W Musaba; Grace Ndeezi; Justus K Barageine; Andrew Weeks; Victoria Nankabirwa; Felix Wamono; Daniel Semakula; James K Tumwine; Julius N Wandabwa Journal: PLoS One Date: 2020-02-10 Impact factor: 3.240
Authors: Milton W Musaba; Grace Ndeezi; Justus K Barageine; Andrew D Weeks; Julius N Wandabwa; David Mukunya; Paul Waako; Beatrice Odongkara; Agnes Arach; Kenneth Tulya-Muhika Mugabe; Agnes Kasede Napyo; Victoria Nankabirwa; James K Tumwine Journal: Matern Health Neonatol Perinatol Date: 2021-07-15