BUSCLAB - Buscopan to Prevent Slow Progress in Labor

NCT03961165 | Completed Phase 3

• 1 other identifier: 2018/2380
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor (Obstetrics)--Complications; Labor; Prolonged, First Stage

Outcome Measures

Primary Outcomes (1)

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

  Time to event variable

  Up to 24 hours

Secondary Outcomes (16)

• 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

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Drug: Butylscopolamine Bromide 20 MG/ML

Placebo

PLACEBO COMPARATOR

1mL 9mg/mL NaCl

Drug: Sodium Chloride 9mg/mL

Interventions

Butylscopolamine Bromide 20 MG/ML DRUG

1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.

Treatment arm

Sodium Chloride 9mg/mL DRUG

1 mL Sodium Chloride 9 mg/mL i.v. Single dose.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 38547322 DERIVED

MeSH Terms

Interventions

Butylscopolammonium Bromide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Trond M Michelsen, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: May 25, 2019
• Primary Completion: August 29, 2021
• Study Completion: June 16, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)