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Effect of preoperative bicarbonate infusion on maternal and perinatal outcomes of obstructed labour in Mbale Regional Referral Hospital: a study protocol for a randomised controlled trial
  1. Milton W Musaba1,2,
  2. Justus K Barageine3,
  3. Grace Ndeezi2,
  4. Julius N Wandabwa1,
  5. Andrew Weeks4
  1. 1 Department of Obstetrics and Gynaecology, Mbale Regional Referral Hospital & Busitema University, Mbale, Uganda
  2. 2 Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda
  3. 3 Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda
  4. 4 Department of Women’s and Children’s Health, University of Liverpool, Liverpool, UK
  1. Correspondence to Dr Milton W Musaba; miltonmusaba{at}gmail.com

Abstract

Introduction To improve maternal and fetal outcomes among patients with obstructed labour (OL) in low-resource settings, the associated electrolyte and metabolic derangements must be adequately corrected. Oral fluid intake during labour and preoperative intravenous fluid replacement following OL corrects the associated dehydration and electrolyte changes, but it does not completely reverse the metabolic acidosis, that is, a cause of intrapartum birth asphyxia and a risk factor for primary postpartum haemorrhage due to uterine atony. Sodium bicarbonate is a safe, effective, cheap and readily available acid buffer, that is widely used by sportspeople to improve performance. It also appears to improve fetal and maternal outcomes in abnormally progressing labour. However, its effects on maternal and fetal outcomes among patients with OL is unknown. We aim at establishing the effect of a single-dose preoperative infusion of sodium bicarbonate on maternal and fetal lactate levels and clinical outcomes among patients with OL.

Methods and analysis This will be a double blind, randomised controlled clinical phase IIb trial. We will randomise 478 patients with OL to receive either 50 mL of placebo with standard preoperative infusion of normal saline (1.5 L) or 4.2 g of sodium bicarbonate solution (50 mL of 50 mmol/L) with the preoperative infusion of normal saline (1.5 L). The primary outcome will be mean lactate levels in maternal capillary blood at 1 hour after study drug administration and in the arterial cord blood at birth. We will use the intention-to-treat analysis approach. Secondary outcomes will include safety, maternal and fetal morbidity and mortality up to 14 days postpartum.

Ethics and dissemination Makerere University School of Medicine Research and Ethics Committee and Uganda National Council for Science and Technology have approved the protocol. Each participant will give informed consent at enrollment.

Trial registration number PACTR201805003364421

  • sodium bicarbonate
  • obstructed labour
  • blood lactate level
  • fetal medicine
  • maternal medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors MWM conceptualised, designed, developed the protocol and drafted the manuscript. JKB, JNW, GN and AW all participated in the conceptualisation, design, development of the protocol and writing of the manuscript by providing critical review and refinement of the research idea as supervisors of my PhD studies. All the authors reviewed and approved the final draft of the manuscript for submission.

  • Funding Survival Pluss project grant number UGA-13-0030 at Makerere University supported this work. Survival Pluss project is funded by The Norwegian Programme for Capacity Development in Higher Education and Research for Development (NORHED) under The Norwegian Agency for Development Cooperation (NORAD).

  • Competing interests None declared.

  • Ethics approval The protocol is approved by the Makerere University School of Medicine Research and Ethics Committee (#REC REF 2017-103), the Uganda National Council for Science and Technology (HS217ES) and the Mbale Regional Referral Research and Ethics Committee (MRRH-REC IN-COM 00/2018).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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