Clinical Trial

Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour

Study acronym: ProLabour
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn if oral bicarbonate can treat prolonged labour in nulliparous women with prolonged labour. The main question it aims to answer is: Do oral bicarbonate and restrictive oxytocin use reduce assisted delivery rate (emergency cesarean and vacuum/forceps delivery) in nulliparous women with prolonged labour. Researchers will compare bicarbonate and placebo (a look-alike substance that contains no drug) to see if bicarbonate works to treat prolonged labour. Participants will: * drink bicarbonate or placebo * have cervical dilatation reassessed after 2 hours. If still slow progression, they will follow standard protocol for oxytocin augmentation * will receive a questionnaire 1 month post partum to assess birth experience 1/3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-22.
Trial Details
NCT Number NCT07321379
Lead Sponsor Copenhagen University Hospital, Hvidovre
Collaborators: University of Copenhagen, Rigshospitalet, Denmark, Aarhus University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Liverpool, University of Amsterdam
Conditions Prolonged Labor, Labor Dystocia
Enrollment 1,520 participants
Start Date 2026-02-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12