Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor (SoBicOL-II)

Busitema University

Status and phase: Not yet enrolling; Phase 3

Conditions: Obstructed Labor

Treatments: Drug: 8.4% sodium bicarbonate solution; Other: 0.9% Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06579690

BusitemaU2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 4 patient groups

8.4g of 8.4% sodium bicarbonate solution Arm

Experimental group

Description:

Each participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Treatment:

Drug: 8.4% sodium bicarbonate solution

12.6g of 8.4% sodium bicarbonate solution Arm

Experimental group

Description:

Each participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Treatment:

Drug: 8.4% sodium bicarbonate solution

16.8g of 8.4% sodium bicarbonate solution Arm

Experimental group

Description:

Each participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Treatment:

Drug: 8.4% sodium bicarbonate solution

Normal Saline 0.9% Arm

Active Comparator group

Description:

Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart.

Treatment:

Other: 0.9% Normal Saline