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

Copenhagen University Hospital, Hvidovre

Status: Not yet enrolling

Conditions: Labor Dystocia; Prolonged Labor

Treatments: Drug: Sodium bicarbonate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07321379

2024-0338

Details and patient eligibility

About

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

Enrollment: 1,520 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,520 participants in 2 patient groups, including a placebo group

Sodium bicarbonate

Experimental group

Description:

Participants receive oral sodium bicarbonate 4.26 gram once.

Treatment:

Drug: Sodium bicarbonate

Placebo

Placebo Comparator group

Description:

Participants receive placebo once.

Treatment:

Drug: Placebo