Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

NCT ID: NCT06579690

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

8.4g of 8.4% sodium bicarbonate solution Arm

Each participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Group Type: EXPERIMENTAL

8.4% sodium bicarbonate solution

Intervention Type: 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

Each participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Group Type: EXPERIMENTAL

8.4% sodium bicarbonate solution

Intervention Type: 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.

16.8g of 8.4% sodium bicarbonate solution Arm

Each participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.

Group Type: EXPERIMENTAL

8.4% sodium bicarbonate solution

Intervention Type: 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.

Normal Saline 0.9% Arm

Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart.

Group Type: ACTIVE_COMPARATOR

0.9% Normal Saline

Intervention Type: OTHER

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

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.

Intervention Type: DRUG

0.9% Normal Saline

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Liverpool

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Cures Within Reach

OTHER

Sponsor Role: collaborator

Open Philanthropy

OTHER

Sponsor Role: collaborator

Busitema University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trond Michelsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

David Mukunya, PhD

Role: PRINCIPAL_INVESTIGATOR

Busitema University

Julius Wandabwa, PhD

Role: PRINCIPAL_INVESTIGATOR

Busitema University

Kenneth Mugabe, MD

Role: PRINCIPAL_INVESTIGATOR

Busitema University

Dan Kibuule, PhD

Role: PRINCIPAL_INVESTIGATOR

Busitema University

Andrew Weeks, MD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Central Contacts

Milton Musaba, PhD

Role: CONTACT

miltonmusaba@gmail.com

256704913791

Ritah Nantale, BSN

Role: CONTACT

ritahclaire24@gmail.com

256702035356

Other Identifiers

BusitemaU2

Identifier Type: -

Identifier Source: org_study_id