A double-blind randomized placebo-controlled four-arm trial to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide to facilitate spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511848-55-00

Enrollment

3000

Registered

2024-10-09

Start date

2023-01-03

Completion date

Unknown

Last updated

2024-10-09

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

Conditions

childbirth

Brief summary

Spontaneous vs operative delivery. Operative delivery defined as cesarean delivery, vacuum or forceps

Interventions

DRUGPlacebo tablets with same size and appearance as the bicarbonate tablets. Contents of placebo tablets are described in the SmPC.

DRUGBuscopan Ampoules 20mg/ml solution for injection.

DRUGSodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion

DRUGSodium Bicarbonate 500 mg Capsules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Spontaneous vs operative delivery. Operative delivery defined as cesarean delivery, vacuum or forceps	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026