A Phase 3 interventional study of 8.4% sodium bicarbonate solution and 0.9% Normal Saline in Obstructed Labor, sponsored by Busitema University. Completed at 1 site in Uganda. Open to female participants aged 16 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Busitema University · Phase 3, Interventional, and Treatment
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 472 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →This is the only study on the registry with Busitema University as lead sponsor.
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Exclusion Criteria:
Each participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
Drug: 8.4% sodium bicarbonate solution
Each participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
Drug: 8.4% sodium bicarbonate solution
Each participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
Drug: 8.4% sodium bicarbonate solution
Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart.
Other: 0.9% Normal Saline
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.
The comparision group will receive 50 mls of 0.9% Normal Saline
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be freely available.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Immediately following publication, No end date
Access criteria: Anyone who wishes to access the data. Any types of data analyses will be permitted.
Ran from May 2025 to primary completion in Apr 2026, 10 months.
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Studies of the drug tested here: Sodium Bicarbonate Solution