Efficacy of oral bicarbonate versus placebo on the risk of assisted delivery in nulliparous women with prolonged labour (ProLabour): protocol fora randomized controlled trial
Female Urogenital Diseases and Pregnancy Complications
Decision date
14/07/2026
Enrollment target
1520
Sites
Denmark
Condition studied
Prolonged labour
Investigational medicinal product(s)
The placebo contains only inert excipients (glucose 3 gsodium chloride 0,65 gsilica 0,05 g) and a flavouring agent (aromalemon–peachfood-grade excipient).Samarin
Eligibility
Age group
18-64 years
Sex
Female
Primary endpoint
The primary endpoint is the incidence of assisted delivery, defined as a composite of emergency caesarean section or instrumental vaginal delivery.
Endpoint detail
Admission of the child to the neonatal intensive care unit within 24 hours after birth. Birth experience (The Childbirth Experience Questionnaire).
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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