Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorCopenhagen University Hospital, Hvidovre

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

1,520 Participants
are divided into 2 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