BUSCLAB - Buscopan to Prevent Slow Progress in Labor

BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor

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.

Inclusion Criteria:

• ≥18 years
• Primiparous women
• Spontaneous onset of labor
• Active phase of labor
• ≥37 weeks of gestation
• Vertex position
• Crossing the alert line, i.e. cervical dilatation of less than one cm per hour in the active phase of first stage of labour (cervix dilation ≥3 - <10 cm)
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national and local regulations

Exclusion Criteria:

• Multiple gestation
• Elective cesarean section
• Women in labor already receiving oxytocin when crossing the alert line
• Fully dilated cervix when crossing the alert line
• Preeclampsia defined as blood pressure ≥140/90 and proteinuria (1 or more on a urine dipstick on more than one occasion) with debut after 20 weeks of pregnancy
• Known intestinal stenosis, ileus or megacolon
• Persisting maternal tachycardia (heart rate >130 beats per minute)
• Known maternal myasthenia gravis
• Persisting fetal tachycardia (fetal heart rate baseline >170 beats per minute)
• Hypersensitivity to any of the ingredients in IMP or placebo (butylscopolamine bromide or sodium chloride)
• Women with heart disease who are under surveillance with heart rate monitoring during labor
• Known fetal heart disease
• Untreated glaucoma