Obstructed LaborPhase 3SoBicOL-IINCT06579690
Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
A Phase 3 study testing 8.4% sodium bicarbonate solution and 0.9% Normal Saline in people with Obstructed Labor, run by Busitema University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Obstructed Labor
- What is being tested?
- 8.4% sodium bicarbonate solution and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteUganda
- Study dates
- 6 May 2025to 4 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with obstructed labour
- Must be a singleton pregnancy
- Must be a term pregnancy (≥37 weeks of gestation)
- Must be in cephalic presentation.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructed Labor
- Being tested
- 8.4% sodium bicarbonate solution, 0.9% Normal Saline
- Keywords
- Sodium bicarbonate, Obstructed labor, Women, Uganda
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8.4% sodium bicarbonate solutionDrug
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.
0.9% Normal SalineOther
The comparision group will receive 50 mls of 0.9% Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| 8.4g of 8.4% sodium bicarbonate solution Arm | Experimental | Each participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. Receives: Drug: 8.4% sodium bicarbonate solution |
| 12.6g of 8.4% sodium bicarbonate solution Arm | Experimental | Each participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. Receives: Drug: 8.4% sodium bicarbonate solution |
| 16.8g of 8.4% sodium bicarbonate solution Arm | Experimental | Each participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. Receives: Drug: 8.4% sodium bicarbonate solution |
| Normal Saline 0.9% Arm | Active comparator | Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart. Receives: Other: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in maternal pH from baseline in each group
Measured: At baseline, 30, 60, 90, 120 and 150 minutes
Mean umbilical blood pH in each arm of the study
Measured: At baseline, 30, 60, 90, 120 and 150 minutes
Secondary outcomes (4)
Mean lactate in maternal and umbilical blood,
Measured: At baseline and at birth.
Number of early neonatal deaths
Measured: Within 7 days
Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm)
Measured: Within 24 hours after administration of the drug
Number of mothers that get primary postpartum hemorrhage
Measured: Within 24 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start6 May 2025
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructed LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Busitema University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Oslo University Hospital, Cures Within Reach, Coefficient Giving
- Responsible party
- Sponsor
- Investigators
- Trond Michelsen, PhD, Principal investigator, Oslo University HospitalDavid Mukunya, PhD, Principal investigator, Busitema UniversityJulius Wandabwa, PhD, Principal investigator, Busitema UniversityKenneth Mugabe, MD, Principal investigator, Busitema UniversityDan Kibuule, PhD, Principal investigator, Busitema UniversityAndrew Weeks, MD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579690
- Sponsor's protocol ID
- BusitemaU2
- Acronym
- SoBicOL-II
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be freely available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06579690
- Acronym / sponsor ID
- SoBicOL-II / BusitemaU2
- Conditions
- Obstructed Labor
- Keywords
- Sodium bicarbonate, Obstructed labor, Women, Uganda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Busitema UniversityUniversity, hospital or other
- Collaborators
- University of Liverpool, Oslo University Hospital, Cures Within Reach, Coefficient Giving
- Study start
- 6 May 2025 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 8.4g of 8.4% sodium bicarbonate solution Arm | Experimental | Drug: 8.4% sodium bicarbonate solutionEach participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. |
| 12.6g of 8.4% sodium bicarbonate solution Arm | Experimental | Drug: 8.4% sodium bicarbonate solutionEach participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. |
| 16.8g of 8.4% sodium bicarbonate solution Arm | Experimental | Drug: 8.4% sodium bicarbonate solutionEach participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart. |
| Normal Saline 0.9% Arm | Active comparator | Other: 0.9% Normal SalineEach participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with obstructed labour
- Must be a singleton pregnancy
- Must be a term pregnancy (≥37 weeks of gestation)
- Must be in cephalic presentation.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8.4% sodium bicarbonate solutionSodium 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. | Drug | 12.6g of 8.4% sodium bicarbonate solution Arm, 16.8g of 8.4% sodium bicarbonate solution Arm, 8.4g of 8.4% sodium bicarbonate solution Arm |
| 0.9% Normal SalineThe comparision group will receive 50 mls of 0.9% Normal Saline | Other | Normal Saline 0.9% Arm |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be freely available.
Related trials for Obstructed Labor
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Calcium Carbonate on Labor Induction
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Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
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RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trond Michelsen, PhD principal investigator
Oslo University Hospital
David Mukunya, PhD principal investigator
Busitema University
Julius Wandabwa, PhD principal investigator
Busitema University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 8.4% sodium bicarbonate solution and 0.9% Normal Saline in people with Obstructed Labor, run by Busitema University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in maternal pH from baseline in each group (time frame: At baseline, 30, 60, 90, 120 and 150 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.