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Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
Sponsor: Busitema University
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.
Official title: Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial
Key Details
Gender
FEMALE
Age Range
16 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
472
Start Date
2025-05-06
Completion Date
2026-03-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
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.
0.9% Normal Saline
The comparision group will receive 50 mls of 0.9% Normal Saline
Locations (1)
Mbale Regional Referral Hospital
Mbale, Uganda