Obstructed Labor
Conditions
Keywords
Sodium bicarbonate, Obstructed labor, Women, Uganda
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.
Interventions
DRUG8.4% sodium bicarbonate solution
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.
OTHER0.9% Normal Saline
The comparision group will receive 50 mls of 0.9% Normal Saline
Sponsors
Busitema University
University of Liverpool
Oslo University Hospital
Cures Within Reach
Open Philanthropy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in maternal pH from baseline in each group | At baseline, 30, 60, 90, 120 and 150 minutes |
| Mean umbilical blood pH in each arm of the study | At baseline, 30, 60, 90, 120 and 150 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Mean lactate in maternal and umbilical blood, | At baseline and at birth. |
| Number of early neonatal deaths | Within 7 days |
| Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm) | Within 24 hours after administration of the drug |
| Number of mothers that get primary postpartum hemorrhage | Within 24 after birth |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORTrond Michelsen, PhD
Oslo University Hospital
PRINCIPAL_INVESTIGATORDavid Mukunya, PhD
Busitema University
PRINCIPAL_INVESTIGATORJulius Wandabwa, PhD
Busitema University
PRINCIPAL_INVESTIGATORKenneth Mugabe, MD
Busitema University
PRINCIPAL_INVESTIGATORDan Kibuule, PhD
Busitema University
PRINCIPAL_INVESTIGATORAndrew Weeks, MD
University of Liverpool
Outcome results
None listed