Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

Busitema University472 enrolled

Overview

The goal of this clinical trial is to determine a universal safe and effective dose of sodium bicarbonate for use among women with Obstructed labour to treat acidosis. It will also learn about the safety of sodium bicarbonate drug among women with Obstructed labour. Researchers will compare sodium bicarbonate drug to normal saline (a look-alike solution) to see if sodium bicarbonate works to treat acidosis. Participants will receive sodium bicarbonate solution or a placebo up to two doses, four hours apart.

Oral bicarbonate is a safe, cheap and effective acid buffer, widely used in sports to improve performance because of its ability to prevent and reverse the effects of metabolic acidosis. Clinically, it is used in intensive care units to treat patients with overwhelming infections or poisoning. In low resource settings, obstructed labor (OL) is a major problem that accounts for 22% of maternal deaths. The fetal harm of OL comes from intrapartum asphyxia, characterized by accumulation of hydrogen ions that cross the placental barrier to cause fetal acidosis. Acidosis causes failure of basic cellular functions resulting into cell death. In a recent Randomised Clinical Trial, the investigators found that 61% of 477 women with OL were acidotic (lactate \>4.8 mmol/L), with a median capillary blood lactate level of 6.9 (3.4-13) mmol/L. The investigators propose an early phase III, placebo-controlled dose-ranging trial to determine the efficacy and safety of a pre-operative infusion of sodium bicarbonate in women with obstructed labour (OL). In a ratio of 1:1:1: 1 100 mls (8.4g), 150 mls (12.6g) and 200 mls (16.8g) of 8.4% sodium bicarbonate solution, or placebo (50 mls of Normal Saline 0.9%). The primary outcome will be mean change in acidosis (pH and lactate levels) from baseline. The secondary outcomes will be neonatal death, safety of sodium bicarbonate, pharmacokinetics of sodium bicarbonate in pregnant women, primary postpartum haemorrhage, sepsis, and maternal death.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

472

Conditions

Obstructed Labor

Interventions

8.4% sodium bicarbonate solutionDRUG

Sodium bicarbonate infusion 8.4% solution The study drug will be contained in identical 25 mL glass vials (Neon Laboratories Ltd, Mumbai, India), administered intravenously as a single bolus dose.

0.9% Normal SalineOTHER

The comparision group will receive 50 mls of 0.9% Normal Saline

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 49 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with obstructed labour * Must be a singleton pregnancy * Must be a term pregnancy (≥37 weeks of gestation) * Must be in cephalic presentation. Exclusion Criteria: * Patients with other obstetric emergencies such as antepartum haemorrhage, preeclampsia and eclampsia (defined as elevated blood pressure of at least 140/90 mm Hg, urine protein of at least 2+, any of the danger signs and fits), premature rupture of membranes and intrauterine fetal death. * Patients with comorbidities such as diabetes mellitus, sickle cell disease, renal disease, liver disease and heart disease. * Patients with hypokalaemia (148 mmol/L) and alkalosis (bicarbonate \>22 mmol/L) because they are more likely to develop adverse drug reactions

Locations (1)

Mbale Regional Referral Hospital

Mbale, Uganda

Outcomes

Primary Outcomes

Mean change in maternal pH from baseline in each group

Time frame: At baseline, 30, 60, 90, 120 and 150 minutes

Mean umbilical blood pH in each arm of the study

Time frame: At baseline, 30, 60, 90, 120 and 150 minutes

Secondary Outcomes

Mean lactate in maternal and umbilical blood,

Time frame: At baseline and at birth.

Number of early neonatal deaths

Time frame: Within 7 days

Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm)

Time frame: Within 24 hours after administration of the drug

Number of mothers that get primary postpartum hemorrhage

Time frame: Within 24 after birth

Data from ClinicalTrials.gov

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