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The ProLabour Trial
EU CTIS ID: 2026-525682-45-00
What this study is testing
The primary objective of the ProLabour Trial is to compare the efficacy, including benefits and harms, of oral bicarbonate on the primary endpoint of assisted delivery, defined as emergency caesarean section or instrumental vaginal birth, in nulliparous women with prolonged labour.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years. Danish or English speaking. Singelton pregnancy. Cephalic presentation. Gestational age ≥35+0 - ≤41+6 (days +weeks) at onset of labour. Normal foetal heart rate pattern documented within the 20 minutes prior to inclusion. Spontaneous onset of labour or non-medical induced labour (balloon catheter and/or artificial rupture of membranes). Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - <10 cm with regular painful contractions. Prolonged labour diagnosed, according to Danish national guidelines.
You likely can't join if
- Significant medical condition in the form of renal or heart condition, assessed on a case-by-case basis. Serious obstetric complication, assessed on a case-by-case basis. Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated). Ongoing oxytocin augmentation at the time of inclusion. Known allergy or intolerance to sodium bicarbonate. Ingestion of sodium bicarbonate in active labour prior to inclusion. Current treatment with the following medicines: Gabapentin, Tetracycline, Ketoconazole
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.