BUSCLAB - Buscopan to Prevent Slow Progress in Labor

Phase 3 Completed 250 enrolled Oslo University Hospital

RandomizedParallel-groupTriple-blindTreatment

Summary

To study the effect of Butylscopolamine Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph.

Timeline

Start: 2019-05-25
Primary completion: 2021-08-29
Completion: 2022-06-16

Outcome

Missed primary endpoint

paper cause-specific HR of 1.00 (95% CI [0.77, 1.29]; p = 0.993). PMID 38547322 ↗

paper was not found to be superior to placebo in preventing slow labor progress PMID 38547322 ↗

Publications

Gaudernack LC, Einarsen AES, Sorbye IK, Lukasse M, Gunnes N, Michelsen TM. The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial. PLoS Med. 2024 Mar 28;21(3):e1004352. doi: 10.1371/journal.pmed.1004352. eCollection 2024 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hyoscine butylbromide	Unknown	20 mg	Intravenous