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.

Study Overview

• Status: Completed
• Conditions: Labor (Obstetrics)--Complications; Labor; Prolonged, First Stage
• Intervention / Treatment: Drug: Butylscopolamine Bromide 20 MG/ML; Drug: Sodium Chloride 9mg/mL

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo university hospital Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; 1mL 20 mg/mL butylscopolamine bromide i.v.	Drug: Butylscopolamine Bromide 20 MG/ML; 1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
Placebo Comparator: Placebo; 1mL 9mg/mL NaCl	Drug: Sodium Chloride 9mg/mL; 1 mL Sodium Chloride 9 mg/mL i.v. Single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of labor from the time when the participant was given IMP to delivery	Time to event variable	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration from when the participant was given IMP, to 10 cm dilatation	Time to event variable	Up to 24 hours
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm	Continuous variable	Up to 24 hours
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery	Time to event variable	Up to 24 hours
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)	Categorical variable, fraction of all deliveries	At birth
Vaginal delivery vs cesarean delivery	Categorical variable, fraction of all deliveries	At birth
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery	Categorical variable, fraction of all deliveries	At birth
Amount of oxytocin given, measured 1. As total time with treatment	Continuous variable, minutes	Up to 24 hours
Amount of oxytocin given, measured 2. As International Units (IU)	Continuous variable	At birth
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP	Continuous variable, scale 1 to 9, where 9 is most severe pain	up to 30 minutes
Postpartum hemorrhage (mL)	Continuous variable	2 hours after birth
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward	Categorical variable, fraction of women with urinary retention	24 hours after birth
Anal sphincter injury	Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries	At birth
Apgar score at 5 minutes and 10 minutes after delivery	Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate	5 and 10 minutes after birth
pH levels in umbilical vein and artery after delivery	Continuous variable	At birth
Admission to the Neonatal Intensive Care Unit	Categorical variable, fraction of deliveries	Within 2 hours after birth
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire	Continuous variable for each category	4 weeks after birth

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Trond M Michelsen, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Mydriatics; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: 2018/2380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No