Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06249061 |
| Other study ID # |
REB 4424 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
January 2024 |
| Source |
McMaster University |
| Contact |
Research Co-ordinator |
| Phone |
905-525-9140 |
| Email |
simioni[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
