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Clinical Trials/NCT03961165
NCT03961165CompletedPhase 3

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

Oslo University Hospital1 site in 1 country250 target enrollmentStarted: May 25, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
250
Locations
1
Primary Endpoint
Duration of labor from the time when the participant was given IMP to delivery
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Treatment arm

Experimental

1mL 20 mg/mL butylscopolamine bromide i.v.

Intervention: Butylscopolamine Bromide 20 MG/ML (Drug)

Placebo

Placebo Comparator

1mL 9mg/mL NaCl

Intervention: Sodium Chloride 9mg/mL (Drug)

Outcomes

Primary Outcomes

Duration of labor from the time when the participant was given IMP to delivery

Time Frame: Up to 24 hours

Time to event variable

Secondary Outcomes

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

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Trond Melbye Michelsen

Attending Physician

Oslo University Hospital

Study Sites (1)

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