About this 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
Eligibility criteria
Qualifiers
Age ≥18 years.
Danish or English speaking.
Cephalic presentation.
Gestational age ≥34+0 - <42+0 (days +weeks) at onset of labour.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sodium bicarbonate
- Placebo
Treatment groups
Sponsors and collaborators
Copenhagen University Hospital, Hvidovre
Lead sponsor
University of Copenhagen
Collaborator
Rigshospitalet, Denmark
Collaborator
Aarhus University Hospital
Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
University of Liverpool
Collaborator
University of Amsterdam
Collaborator