Study protocol for the BUSCopan in LABor (BUSCLAB) study: A randomized placebo-controlled trial investigating the effect of butylscopolamine bromide to prevent prolonged labor

Abstract

Background: First-time mothers are prone to prolonged labor, defined as the crossing of partograph alert or action lines. Prolonged labor may occur among as many as one out of five women, and is associated with a range of adverse birth outcomes. Oxytocin is the standard treatment for prolonged labor, but has a narrow therapeutic window, several adverse effects and limited efficacy. Despite poor evidence, labor wards often use antispasmodic agents to treat prolonged labor. The antispasmodic drug butylscopolamine bromide (Buscopan®) may shorten duration of labor, but studies on prevention of prolonged labor are lacking. In this randomized double-blind placebo-controlled clinical trial, we aim to evaluate the effect of butylscopolamine bromide on duration of labor in first-time mothers showing first signs of slow labor progress by crossing the World Health Organization partograph alert line.

Methods and analysis: The study is a single center study at Oslo University Hospital, Oslo, Norway. We will recruit 250 primiparous women with spontaneous labor start at term. Women are included in the first stage of labor if they show signs of slow labor progress, defined as the crossing of the partograph alert line with a cervical dilation between 3-9 cm. Participants are randomized 1:1 to either 20 mg intravenous butylscopolamine bromide or intravenous placebo (1 mL sodium chlorine 9 mg/mL). We considered a mean difference of 60 minutes in labor duration clinically relevant. The primary outcome is duration of labor from the provision of the investigational medicinal product to vaginal delivery. The secondary outcomes include change in labor pain, use of oxytocin augmentation, delivery mode, and maternal birth experience. The primary data for the statistical analysis will be the full analysis set and will occur on completion of the study as per the prespecified statistical analysis plan. The primary outcome will be analyzed using Weibull regression, and we will treat cesarean delivery as a censoring event.

Fig 1. Schedule of enrollment, intervention and assessments.

IMP = Investigational Medicinal Product. CTG = Cardiotocography—continuous fetal heart tracing. VAS = Visual Analogue Scale. ^aPhysical Examination fetus includes fetal position and CTG—continuous fetal heart tracing ^bVital signs include maternal blood pressure and heart rate. Height and body weight are obtained from pregnancy charts ^cPhysical Examination newborn includes an examination of general appearance.

Fig 2. BUSCLAB trial design.

The flow chart summarizes the design of the BUSCLAB trial. *Crossing of the alert line for slow labor progress, according to the World Health Organization partograph. If the labor curve crosses to the right of the alert line, the cervical dilation rate is <1 cm per hour. NaCl = Sodium Chloride. IMP = Investigational Medicinal Product.