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CompletedNCT03961165Updated Dec 20, 2022

BUSCLAB - Buscopan to Prevent Slow Progress in Labor

A Phase 3 interventional study of Butylscopolamine Bromide 20 MG/ML and Sodium Chloride 9mg/mL in Labor (Obstetrics)--Complications and Labor; Prolonged, First Stage, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Oslo University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Labor (Obstetrics)--Complications
  • Labor; Prolonged, First Stage
03

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Treatment arm

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

    Drug: Butylscopolamine Bromide 20 MG/ML

  • Placebo comparator
    Placebo

    1mL 9mg/mL NaCl

    Drug: Sodium Chloride 9mg/mL

Interventions

  • DrugButylscopolamine Bromide 20 MG/ML

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

  • DrugSodium Chloride 9mg/mL

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

06

What researchers measure

Primary outcomes

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

    Time to event variable

    Time frame: Up to 24 hours

Secondary outcomes

  1. Duration from when the participant was given IMP, to 10 cm dilatation

    Time to event variable

    Time frame: Up to 24 hours

  2. Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm

    Continuous variable

    Time frame: Up to 24 hours

  3. Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery

    Time to event variable

    Time frame: Up to 24 hours

  4. Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)

    Categorical variable, fraction of all deliveries

    Time frame: At birth

  5. Vaginal delivery vs cesarean delivery

    Categorical variable, fraction of all deliveries

    Time frame: At birth

  6. Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery

    Categorical variable, fraction of all deliveries

    Time frame: At birth

  7. Amount of oxytocin given, measured 1. As total time with treatment

    Continuous variable, minutes

    Time frame: Up to 24 hours

  8. Amount of oxytocin given, measured 2. As International Units (IU)

    Continuous variable

    Time frame: At birth

  9. 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

    Time frame: up to 30 minutes

  10. Postpartum hemorrhage (mL)

    Continuous variable

    Time frame: 2 hours after birth

  11. Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward

    Categorical variable, fraction of women with urinary retention

    Time frame: 24 hours after birth

  12. Anal sphincter injury

    Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries

    Time frame: At birth

  13. 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

    Time frame: 5 and 10 minutes after birth

  14. pH levels in umbilical vein and artery after delivery

    Continuous variable

    Time frame: At birth

  15. Admission to the Neonatal Intensive Care Unit

    Categorical variable, fraction of deliveries

    Time frame: Within 2 hours after birth

  16. Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire

    Continuous variable for each category

    Time frame: 4 weeks after birth

07

Study locations

1 site
  • Oslo University Hospital Rikshospitalet
    Oslo, 0424, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03961165
Lead sponsor
Oslo University Hospital
Responsible party
Trond Melbye Michelsen (Attending Physician, Oslo University Hospital) — Principal investigator
First posted
May 23, 2019
Start date
May 25, 2019
Primary completion
Aug 29, 2021
Completion
Jun 16, 2022
Last update
Dec 20, 2022

Study contacts

Trond M Michelsen, MD, PhD
principal investigator · Oslo University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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