Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

NCT06579690 | Completed Phase 3 DMC

• 1 other identifier: BusitemaU2
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sodium bicarbonate; Obstructed labor; Women; Uganda

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (4)

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.

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.

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.

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.

Other: 0.9% Normal Saline

Interventions

8.4% sodium bicarbonate solution DRUG

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.

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 Saline OTHER

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

Normal Saline 0.9% Arm

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with obstructed labour
• Must be a singleton pregnancy
• Must be a term pregnancy (≥37 weeks of gestation)
• Must be in cephalic presentation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: collaborator
• Cures Within Reach: collaborator
• Open Philanthropy: collaborator
• University of Liverpool: collaborator
• Busitema University: lead

Study Sites (1)

Mbale Regional Referral Hospital

Mbale, Uganda

Location

MeSH Terms

Conditions

Dystocia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: May 6, 2025
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication, No end date
• Access Criteria: Anyone who wishes to access the data. Any types of data analyses will be permitted.

Locations

UG (1)