Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Sponsor:
Liz Darling
Organization:
McMaster University
Study Overview
Official Title:
A Randomised Controlled Feasibility Trial of Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Labour-Aide
Brief Summary:
Sodium bicarbonate is often used by athletes to improve their muscles 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None