• Oral Sodium Bicarbonate for the Prevention of Labour Dystocia

  NCT06249061

  Not yet recruitingInterventionalNot ApplicableUpdated Jul 23, 2025
• SAINT: Safe Induction of Labor Trial

  NCT05719467

  RecruitingInterventionalPhase 3Updated Apr 4, 2024
• Bicarbonate Given During Dystocic Labor

  NCT02805387

  CompletedInterventionalNot ApplicableUpdated Jun 20, 2016
• Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

  NCT06579690

  CompletedInterventionalPhase 3Updated Apr 20, 2026
• The Study of Giving Birth, a Study About Treatment of Labor Dystocia

  NCT04649593

  CompletedInterventionalNot ApplicableUpdated Mar 31, 2022
• Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor

  NCT07742748

  RecruitingInterventionalNot ApplicableUpdated Aug 4, 2026

ClinicalTrials.gov ID

NCT07321379

Lead Sponsor

Copenhagen University Hospital, HvidovreOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,520Estimated

Last Update Posted

Jan 12, 2026Actual

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Jan 31, 2028Estimated

Completion Date

Jan 31, 2028Estimated

Official Title

Efficacy of Bicarbonate on the Risk of Assisted Delivery in Danish Nulliparous Women With Prolonged Labour: a Double-blinded Parallel Randomized Controlled Trial (The ProLabour Trial)

Brief Summary

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

• Prolonged Labor
• Labor Dystocia

• Sodium bicarbonate
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age ≥18 years.
• 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:

• 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.
• 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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Copenhagen University Hospital, HvidovreOTHER

Collaborators

University of CopenhagenOTHER

Rigshospitalet, DenmarkOTHER

Aarhus University HospitalOTHER

Copenhagen Trial Unit, Center for Clinical Intervention ResearchOTHER

University of LiverpoolOTHER

University of AmsterdamOTHER

nannam@sund.ku.dk