Dataset Information

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.

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.

SUBMITTER: Musaba MW

PROVIDER: S-EPMC7872290 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

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.

Musaba Milton W MW Wandabwa Julius N JN Ndeezi Grace G Weeks Andrew D AD Mukunya David D Waako Paul P Nankabirwa Victoria V Mugabe Kenneth Tulya-Muhika KT Semakula Daniel D Tumwine James K JK Barageine Justus K JK

PloS one 20210209 2

<h4>Introduction</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>We conducted a double blind, ...[more]

PMID: 33561141

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Project description: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 analysisThis 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 disseminationMakerere 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 numberPACTR201805003364421.

Project description:Importance: Trichiasis surgery programs globally have faced high rates of poor surgical outcomes. Identifying correctable risk factors for improving long-term outcomes is essential for countries targeting elimination of trachoma as a public health problem.Objective: To determine whether the location of trichiatic eyelashes prior to surgery influences development of post-operative trichiasis (PTT) within two years after surgery.Design: Secondary data analysis of four randomized clinical trials evaluating methods to improve trichiasis surgery outcomes. These include the Surgery for Trichiasis, Antibiotics for Recurrence (STAR) trial, Partnership for Rapid Elimination of Trachoma (PRET-Surgery), absorbable versus silk sutures trial, and epilation versus surgery for minor trichiasis trial.Setting: Primary trials were conducted in rural areas of Ethiopia and Tanzania.Interventions or exposures: Trichiasis surgery performed with either the bilamellar tarsal rotation procedure or posterior lamellar rotation procedure.Main outcomes: Prevalence of PTT within two years after surgery, location of trichiatic eyelashes pre-operatively and post-operatively.Results: 6,747 eyelids that underwent first-time trichiasis surgery were included. PTT rates varied by study, ranging from 10-40%. PTT was less severe (based on number of trichiatic eyelashes) than initial trichiasis for 72% of those developing PTT, and only 2% of eyelids were worse at follow up than pre-operatively. Eyelids with central only-trichiasis pre-operatively had lower rates of PTT than eyelids with peripheral only trichiasis in each of the three trials that included severe TT cases. 10% of eyelids with peripheral trichiasis pre-operatively that develop PTT have central TT post-operatively.Conclusions and relevance: Pre-operative central trichiasis is less likely than peripheral trichiasis to be associated with subsequent PTT. Regardless of type of surgery, surgeon skill levels, or pre-operative trichiasis severity, the presence of peripheral trichiasis pre-operatively is associated with higher rates of PTT. Making an incision that extends the length of the eyelid and adequately rotating the nasal and temporal aspects of the eyelid when suturing may help to minimize the chance of developing peripheral PTT.Trial registration: ClinicalTrials.gov PRET: NCT00886015; Suture: NCT005228560; Epilation: NCT00522912.

Dataset Information

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

Objective

Methods

Intervention

Outcome measures

Results

Conclusion

Trial registration

Publications

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.

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