Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

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.

Conditions

• Obstructed Labor

Interventions

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.

OTHER

0.9% Normal Saline

The comparision group will receive 50 mls of 0.9% Normal Saline

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Cures Within Reach

  collaborator OTHER

• Open Philanthropy

  collaborator OTHER

• Busitema University

  lead OTHER

Principal Investigators

• Trond Michelsen, PhD · Oslo University Hospital

• David Mukunya, PhD · Busitema University

• Julius Wandabwa, PhD · Busitema University

• Kenneth Mugabe, MD · Busitema University

• Dan Kibuule, PhD · Busitema University

• Andrew Weeks, MD · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-06

Primary Completion

2026-04-04

Completion

2026-04-04

Countries

• Uganda

Study Locations