Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07321379
NA

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

Sponsor: Copenhagen University Hospital, Hvidovre

View on ClinicalTrials.gov

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

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)

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

1520

Start Date

2026-02-01

Completion Date

2028-01-31

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Sodium bicarbonate

4,26 gram given once.

DRUG

Placebo

Placebo given once.

Locations (3)

Aarhus University Hospital

Aarhus, Denmark

Copenhagen University Hospital, Hvidovre

Copenhagen, Denmark

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark