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Not yet recruiting NCT07321379

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

No phase Interventional Prolonged Labor Labor Dystocia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium bicarbonate, Placebo.
Who it may be relevant to
Registry conditions: Prolonged Labor, Labor Dystocia. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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

Interventions

  • Drug Sodium bicarbonate
    4,26 gram given once.
  • Drug Placebo
    Placebo given once.

Primary outcome measures

  • Difference in incidence of assisted delivery [Time frame: At birth]
Secondary outcome measures (11)
  • Difference in adverse neonatal outcome [Time frame: From birth until 7 days postpartum]
  • Difference in total oxytocin dose [Time frame: Intrapartum]
  • Difference in duration of active labour [Time frame: Intrapartum]
  • Difference in birth experience [Time frame: One month postpartum]
  • Difference in amniotic fluid lactate (AFL) concentration [Time frame: Measured at inclusion and two hours later.]
  • Difference in intra- or postpartum infection [Time frame: Intrapartum and until 7 days postpartum]
  • Difference in epidural analgesia [Time frame: Intrapartum]
  • Difference in number of women getting antibiotics during labour [Time frame: Intrapartum]
  • Difference in postpartum blood loss [Time frame: From birth until 24 hours postpartum]
  • Difference in women receiving tocolytics used during labour [Time frame: Intrapartum]
  • Difference in number of 3rd or 4th-degree perineal tears [Time frame: Within 2 hours after birth]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 3 centers
  • Aarhus University Hospital — Aarhus
  • Copenhagen University Hospital, Hvidovre — Copenhagen
  • Copenhagen University Hospital, Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07321379 · 2024-0338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗