Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2019-05-25
2022-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment arm
1mL 20 mg/mL butylscopolamine bromide i.v.
Butylscopolamine Bromide 20 MG/ML
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
Placebo
1mL 9mg/mL NaCl
Sodium Chloride 9mg/mL
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
Interventions
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Butylscopolamine Bromide 20 MG/ML
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
Sodium Chloride 9mg/mL
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Trond Melbye Michelsen
Attending Physician
Principal Investigators
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Trond M Michelsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital Rikshospitalet
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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2018/2380
Identifier Type: -
Identifier Source: org_study_id