Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour
NCT ID: NCT07321379
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1520 participants
INTERVENTIONAL
2026-02-01
2028-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Bicarbonate/placebo will be prepared in another room by a person not involved in the specific labour. The person will give the drink directly to the woman. Amniotic fluid will be collected and analysed externally.
Study Groups
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Sodium bicarbonate
Participants receive oral sodium bicarbonate 4.26 gram once.
Sodium bicarbonate
4,26 gram given once.
Placebo
Participants receive placebo once.
Placebo
Placebo given once.
Interventions
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Sodium bicarbonate
4,26 gram given once.
Placebo
Placebo given once.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
50 Years
FEMALE
No
Sponsors
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University of Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Aarhus University Hospital
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
University of Liverpool
OTHER
University of Amsterdam
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Responsible Party
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Nanna Maaløe
Associate Professor
Principal Investigators
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Nanna Maaløe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Copenhagen University Hospital, Hvidovre
Copenhagen, , Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-0338
Identifier Type: -
Identifier Source: org_study_id
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