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.

introductionTo 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.