Clinical trial NCT06579690: Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
Official title: Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obstructed Labor
Keywords: Sodium bicarbonate
Obstructed labor
Women
Uganda
Lead sponsor: Busitema University
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: Oslo University Hospital
name: Cures Within Reach
name: Open Philanthropy
First posted: 2024-08-30
Enrollment: 280
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in maternal pH from baseline in each group
timeFrame: At baseline, 30, 60, 90, 120 and 150 minutes
measure: Mean umbilical blood pH in each arm of the study
timeFrame: At baseline, 30, 60, 90, 120 and 150 minutes
Secondary outcomes:
measure: Mean lactate in maternal and umbilical blood,
timeFrame: At baseline and at birth.
measure: Number of early neonatal deaths
timeFrame: Within 7 days
measure: Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm)
timeFrame: Within 24 hours after administration of the drug
measure: Number of mothers that get primary postpartum hemorrhage
timeFrame: Within 24 after birth
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Trond Michelsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busitema University
name: David Mukunya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busitema University
name: Julius Wandabwa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busitema University
name: Kenneth Mugabe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Busitema University
name: Dan Kibuule, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Andrew Weeks, MD
role: PRINCIPAL_INVESTIGATOR
References: