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

Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obstructed Labor
• Intervention / Treatment: Drug: 8.4% sodium bicarbonate solution; Other: 0.9% Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Phase 3

Contacts and Locations

Study Locations

• Uganda
  • Mbale, Uganda
    • Mbale Regional Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8.4g of 8.4% sodium bicarbonate solution Arm; 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; 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.
Experimental: 12.6g of 8.4% sodium bicarbonate solution Arm; 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; 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.
Experimental: 16.8g of 8.4% sodium bicarbonate solution Arm; 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; 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.
Active Comparator: Normal Saline 0.9% Arm; Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart.	Other: 0.9% Normal Saline; The comparision group will receive 50 mls of 0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Busitema University
• Collaborators: Oslo University Hospital; University of Liverpool; Cures Within Reach; Open Philanthropy
• Investigators: Principal Investigator: Trond Michelsen, PhD, Oslo University Hospital; Principal Investigator: David Mukunya, PhD, Busitema University; Principal Investigator: Julius Wandabwa, PhD, Busitema University; Principal Investigator: Kenneth Mugabe, MD, Busitema University; Principal Investigator: Dan Kibuule, PhD, Busitema University; Principal Investigator: Andrew Weeks, MD, University of Liverpool

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Actual): April 4, 2026
• Study Completion (Actual): April 4, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Women; Uganda; Sodium bicarbonate; Obstructed labor
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Dystocia; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: BusitemaU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be freely available.
• IPD Sharing Time Frame: Immediately following publication, No end date
• IPD Sharing Access Criteria: Anyone who wishes to access the data. Any types of data analyses will be permitted.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No