- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249061
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia (Labour-Aide)
A Randomised Controlled Feasibility Trial of Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Co-ordinator
- Phone Number: 26654 905-525-9140
- Email: simioni@mcmaster.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Sodium Bicarbonate
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.
|
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.
Other Names:
|
No Intervention: Usual Care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of a full-scale RCT
Time Frame: 8 months of recruitment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure to achieve a spontaneous vaginal birth
Time Frame: At the time of birth
|
Composite of Caesarean section and assisted vaginal birth
|
At the time of birth
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liz Darling, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 4424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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