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

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

Conditions

• Prolonged Labor
• Labor Dystocia

Interventions

DRUG

Sodium bicarbonate

4,26 gram given once.

DRUG

Placebo

Placebo given once.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• University of Amsterdam

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  lead OTHER

Principal Investigators

• Nanna Maaløe, PhD · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• Denmark

Study Locations