Efficacy of oral bicarbonate versus placebo on the risk of assisted delivery in nulliparous women with prolonged labour (ProLabour): protocol fora randomized controlled trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525682-45-00

Enrollment

1520

Registered

2026-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged labour

Brief summary

The primary endpoint is the incidence of assisted delivery, defined as a composite of emergency caesarean section or instrumental vaginal delivery.

Detailed description

Admission of the child to the neonatal intensive care unit within 24 hours after birth. Birth experience (The Childbirth Experience Questionnaire).

Interventions

DRUGThe placebo contains only inert excipients (glucose 3 g

DRUGsodium chloride 0

DRUG65 g

DRUGsilica 0

DRUG05 g) and a flavouring agent (aroma

DRUGlemon–peach

DRUGfood-grade excipient).

DRUGSamarin

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of assisted delivery, defined as a composite of emergency caesarean section or instrumental vaginal delivery.	—

Secondary

Measure	Time frame
Admission of the child to the neonatal intensive care unit within 24 hours after birth. Birth experience (The Childbirth Experience Questionnaire).	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 15, 2026