Oral Sodium Bicarbonate for the Prevention of Labour Dystocia

NCT06249061 | Not Yet Recruiting

• 1 other identifier: REB 4424
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sodium bicarbonate is often used by athletes to improve their muscle's ability to contract and power their activity. It works by decreasing the risk of lactic acid build-up, which causes cramping and fatigue. Some research suggests that using sodium bicarbonate in labour could help to improve the ability of the uterus to contract, helping to prevent labour dystocia (stalled or slow progress in labour). This could ultimately increase the chance of spontaneous vaginal delivery. This research is being done to investigate whether drinking sodium bicarbonate (commonly known as baking soda) dissolved in water as a hydration drink could benefit women in labour and increase the chance of a vaginal birth. In order to answer this question, pregnant people from London, Markham and Mississauga midwifery practices are being recruited to participate in this study. Participants will be randomly assigned to one of two groups when they are admitted to hospital in labour. One group will be asked to drink normal fluids of their choice while they are in labour (usual care). The second group will be asked to consume a drink made of baking soda and water, as well as normal fluids of their choice. Mode of birth and the use of birth interventions will be compared between the two groups. Infant outcomes will be compared to ensure that the use this drink in labour is safe. A risk of consuming sodium bicarbonate is gastrointestinal disturbance. The number of people who reported gastrointestinal upset will also be compared between the two groups. If this study shows that those who drank sodium bicarbonate in labour had an increased chance of vaginal birth and that it is safe, this low-cost, low-risk treatment has the potential to reduce birth interventions for pregnant people and their babies.

Conditions

Labour Dystocia

Keywords

dystocia; labor; sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• Feasibility of a full-scale RCT

  Feasibility will be determined by assessing recruitment, compliance, participant retention, side effects, completeness of data, participant satisfaction and facilitators and barriers to study implementation.

  8 months of recruitment

Secondary Outcomes (1)

• Failure to achieve a spontaneous vaginal birth

  At the time of birth

Study Arms (2)

Oral Sodium Bicarbonate

EXPERIMENTAL

Those in the intervention group will be encouraged to sip a solution of sodium bicarbonate (1 imperial teaspoon (\~5g) of sodium bicarbonate dissolved into 250ml of water; if the entire 250mL is consumed, another 1 imperial teaspoon (\~5g) of sodium bicarbonate dissolved in 250mL of water will be provided to the patient) throughout labour with other drinks as desired. All other care will remain the same.

Dietary Supplement: oral sodium bicarbonate

Usual Care

NO INTERVENTION

Those in the usual care group will be encouraged to sip fluids of their choice throughout labour as they would normally be encouraged to do. All other care will remain the same.

Interventions

oral sodium bicarbonate DIETARY_SUPPLEMENT

Those in the oral sodium bicarbonate intervention group will be encouraged to sip a solution of 1 imperial teaspoon (\~5g) of sodium bicarbonate dissolved into 250ml of water throughout labour with other drinks. If the first solution is fully consumed, a second solution will be prepared and offered. Thus, each participant can receive a maximum dose of 2 imperial teaspoons (\~10g) of sodium bicarbonate.

Also known as: Bicarbonate De Soude Usp by Laboratoire Atlas Inc

Oral Sodium Bicarbonate

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant,
• Nulliparous,
• Cephalic presenting,
• Live, singleton fetus,
• Planning hospital birth,
• Under the care of a midwife
• In spontaneous active labour (with or without cervical ripening), and
• Greater than or equal to (≥) 37weeks, and 0 days gestation. There is no maximum gestation, so long as the labour was spontaneous

You may not qualify if:

• Planning caesarean birth,
• Hypertension requiring treatment,
• Diabetes or gestational diabetes requiring pharmacological treatment,
• On a low sodium diet,
• Use of illicit drugs in pregnancy, or
• Unable to provide informed consent or understand instructions on ingestion of the substance
• Oxytocin induction of labour, or
• Oxytocin augmentation of labour prior to randomisation

Sponsors & Collaborators

• Liz Darling: lead
• Trillium Health Partners: collaborator
• London Health Sciences Centre: collaborator
• Oak Valley Health: collaborator

MeSH Terms

Conditions

Dystocia

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Liz Darling, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Co-ordinator

CONTACT

905-525-9140; simioni@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share