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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)
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
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
No
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital, Hvidovre
Copenhagen, Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Start Date
February 1, 2026
Primary Completion Date
January 31, 2028
Completion Date
January 31, 2028
Last Updated
January 12, 2026
1,520
ESTIMATED participants
Sodium bicarbonate
DRUG
Placebo
DRUG
Lead Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02318121