Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour
Starting soon · Not applicable · Has a placebo group
Conditions studied: Prolonged Labor, Labor Dystocia
In brief
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
Key facts
- Study ID
- NCT07321379
- Run by
- Copenhagen University Hospital, Hvidovre
- People needed
- 1520
- Starts
- 2026-02-01
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years.
- Danish or English speaking.
- Cephalic presentation.
- Gestational age ≥34+0 - <42+0 (days +weeks) at onset of labour.
- Normal foetal heart rate pattern in 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: Cervical dilatation progresses at less than 2 cm over a 4-hour period.
You may not qualify if…
- Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated)
- Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis.
- Serious obstetric complication
- Known allergy or intolerance to sodium bicarbonate.
- Ingestion of sodium bicarbonate in active labour prior to inclusion.
- Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)
Where it is running
- Aarhus University Hospital — Aarhus, Denmark
- Copenhagen University Hospital, Hvidovre — Copenhagen, Denmark
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark
Full record on ClinicalTrials.gov
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