Labour DystociaLabour-AideNCT06249061
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
A study testing oral sodium bicarbonate in people with Labour Dystocia, run by Liz Darling.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Dystocia
- What is being tested?
- oral sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2027to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Controlled Feasibility Trial of Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
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.
Read the detailed description
Sodium bicarbonate is used by athletes to improve muscle contractility and decrease the risk of lactic acid build-up. A moderately sized efficacy study suggests that these proposed effects may be beneficial for nulliparous women in labor to maintain efficiency of labour contractions. Sodium bicarbonate may be useful for improving the contractility of the uterus, helping to prevent labour slowing (dystocia) and ultimately increasing the rate of spontaneous vaginal deliveries. Large scale randomized controlled trials (RCTs) are necessary to determine the effectiveness of sodium bicarbonate for prevention of labour dystocia.
This is an unblinded, open-label, two-arm (treatment vs. usual care control), feasibility RCT evaluating oral sodium bicarbonate for the prevention of labour dystocia for nulliparous midwifery clients at two centres. This study will be conducted with the primary aim of determining feasibility for a full-scale RCT to answer the question: are nulliparous women in midwifery care who receive oral sodium bicarbonate as a hydration drink in labour more or less likely to fail to achieve spontaneous vaginal birth compared to women who drink fluids of their choice? This feasibility study will take place at 4 hospitals in Ontario (Mississauga Hospital, Credit Valley Hospital, Markham Stouffville Hospital, London Health Sciences Centre) and will aim to recruit as many participants as possible during an 8-month period.
- Conditions
- Labour Dystocia
- Being tested
- oral sodium bicarbonate
- Keywords
- dystocia, labor, sodium bicarbonate
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sodium bicarbonateDietary supplement
Also called Bicarbonate De Soude Usp by Laboratoire Atlas Inc
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months of recruitment
Secondary outcomes (1)
Failure to achieve a spontaneous vaginal birth
Composite of Caesarean section and assisted vaginal birth
Measured: At the time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study startOct 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour DystociaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liz Darling
- Sponsor type
- University, hospital or other
- Collaborators
- Trillium Health Partners, London Health Sciences Centre, Oak Valley Health
- Responsible party
- Sponsor-investigator, Liz Darling, McMaster University
- Investigators
- Liz Darling, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249061
- Sponsor's protocol ID
- REB 4424
- Acronym
- Labour-Aide
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No