Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor (NCT06579690) | Clinical Trial Compass
CompletedPhase 3
Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
Uganda472 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range
16 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in maternal pH from baseline in each group
Timeframe: At baseline, 30, 60, 90, 120 and 150 minutes
2
Mean umbilical blood pH in each arm of the study
Timeframe: At baseline, 30, 60, 90, 120 and 150 minutes