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 years.
Danish or English speaking.
Cephalic presentation.
Gestational age ≥34+0 - <42+0 (days +weeks) at onset of labour.
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.
Parallel
Sodium bicarbonate
Drug4,26 gram given once.
Placebo
DrugPlacebo given once.
Difference in incidence of assisted delivery
Defined as a composite of emergency caesarean section and instrumental vaginal delivery
Difference in adverse neonatal outcome
Composite of perinatal adverse outcomes within the first 7 days of life, including perinatal mortality and neonatal morbidity. Neonatal morbidity is defined as arterial umbilical cord pH \<7.10, resuscitation (bag and mask or intubation), hypoxic ischemic encephalopathy II-III, intracranial haemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.
Difference in total oxytocin dose
Administered intrapartum for augmentation.
Difference in duration of active labour
From diagnosis of active labour until childbirth
Difference in birth experience
Patient reported using Childbirth Experience Questionnaire (CEQ) which uses a 4-point Likert scale and higher scores indicate a more positive experience.
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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
This trial is not recruiting at the moment. You can still explore other options:
