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NCT06249061
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Conditions: Labour Dystocia
Sex: Female
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Liz Darling
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.
Eligibility Criteria
Inclusion Criteria:
1. Pregnant,
2. Nulliparous,
3. Cephalic presenting,
4. Live, singleton fetus,
5. Planning hospital birth,
6. Under the care of a midwife
7. In spontaneous active labour (with or without cervical ripening), and
8. Greater than or equal to (≥) 37weeks, and 0 days gestation. There is no maximum gestation, so long as the labour was spontaneous
Exclusion Criteria:
1. Planning caesarean birth,
2. Hypertension requiring treatment,
3. Diabetes or gestational diabetes requiring pharmacological treatment,
4. On a low sodium diet,
5. Use of illicit drugs in pregnancy, or
6. Unable to provide informed consent or understand instructions on ingestion of the substance
7. Oxytocin induction of labour, or
8. Oxytocin augmentation of labour prior to randomisation
Source: ClinicalTrials.gov (NCT06249061). StuddyBuddy aggregates publicly available trial information.