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

Study acronym: ProLabour
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 32 words
    • Secondary endpoints: details revised at 1 of 11 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07321379
Lead Sponsor Copenhagen University Hospital, Hvidovre
Collaborators: University of Copenhagen, Rigshospitalet, Denmark, Aarhus University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Liverpool, University of Amsterdam
Conditions
(from sponsor)		 Prolonged Labor, Labor Dystocia
Related terms Dystocia
Enrollment 1,520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov