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Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour
Sponsor: Copenhagen University Hospital, Hvidovre
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
Official title: Efficacy of Bicarbonate on the Risk of Assisted Delivery in Danish Nulliparous Women With Prolonged Labour: a Double-blinded Parallel Randomized Controlled Trial (The ProLabour Trial)
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
1520
Start Date
2026-02-01
Completion Date
2028-01-31
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Sodium bicarbonate
4,26 gram given once.
Placebo
Placebo given once.
Locations (3)
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital, Hvidovre
Copenhagen, Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark