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出境医 / 临床实验 / BUSCLAB - Buscopan to Prevent Slow Progress in Labor

BUSCLAB - Buscopan to Prevent Slow Progress in Labor

Study Description
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.

Condition or disease Intervention/treatment Phase
Labor (Obstetrics)--Complications Labor; Prolonged, First Stage Drug: Butylscopolamine Bromide 20 MG/ML Drug: Sodium Chloride 9mg/mL Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Duration from when the participant was given IMP, to 10 cm dilatation [ Time Frame: Up to 24 hours ]
    Time to event variable

  2. Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm [ Time Frame: Up to 24 hours ]
    Continuous variable

  3. Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery [ Time Frame: Up to 24 hours ]
    Time to event variable

  4. Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries

  5. Vaginal delivery vs cesarean delivery [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries

  6. Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries

  7. Amount of oxytocin given, measured 1. As total time with treatment [ Time Frame: Up to 24 hours ]
    Continuous variable, minutes

  8. Amount of oxytocin given, measured 2. As International Units (IU) [ Time Frame: At birth ]
    Continuous variable

  9. Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP [ Time Frame: up to 30 minutes ]
    Continuous variable, scale 1 to 9, where 9 is most severe pain

  10. Postpartum hemorrhage (mL) [ Time Frame: 2 hours after birth ]
    Continuous variable

  11. Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward [ Time Frame: 24 hours after birth ]
    Categorical variable, fraction of women with urinary retention

  12. Anal sphincter injury [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries

  13. Apgar score at 5 minutes and 10 minutes after delivery [ Time Frame: 5 and 10 minutes after birth ]
    Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate

  14. pH levels in umbilical vein and artery after delivery [ Time Frame: At birth ]
    Continuous variable

  15. Admission to the Neonatal Intensive Care Unit [ Time Frame: Within 2 hours after birth ]
    Categorical variable, fraction of deliveries

  16. Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire [ Time Frame: 4 weeks after birth ]
    Continuous variable for each category


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Trond M Michelsen, MD, PhD +4723070000 trmi1@ous-hf.no

Locations
Layout table for location information
Norway
Oslo University Hospital Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Trond M Michelsen, MD, PhD    +472307000    trmi1@ous-hf.no   
Contact: Lise C Gaudernack, MPH    +4723072640    lisgau@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Trond M Michelsen, MD, PhD Oslo University Hospital
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE May 25, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Duration of labor from the time when the participant was given IMP to delivery [ Time Frame: Up to 24 hours ]
Time to event variable
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Duration from when the participant was given IMP, to 10 cm dilatation [ Time Frame: Up to 24 hours ]
    Time to event variable
  • Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm [ Time Frame: Up to 24 hours ]
    Continuous variable
  • Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery [ Time Frame: Up to 24 hours ]
    Time to event variable
  • Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries
  • Vaginal delivery vs cesarean delivery [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries
  • Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries
  • Amount of oxytocin given, measured 1. As total time with treatment [ Time Frame: Up to 24 hours ]
    Continuous variable, minutes
  • Amount of oxytocin given, measured 2. As International Units (IU) [ Time Frame: At birth ]
    Continuous variable
  • Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP [ Time Frame: up to 30 minutes ]
    Continuous variable, scale 1 to 9, where 9 is most severe pain
  • Postpartum hemorrhage (mL) [ Time Frame: 2 hours after birth ]
    Continuous variable
  • Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward [ Time Frame: 24 hours after birth ]
    Categorical variable, fraction of women with urinary retention
  • Anal sphincter injury [ Time Frame: At birth ]
    Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries
  • Apgar score at 5 minutes and 10 minutes after delivery [ Time Frame: 5 and 10 minutes after birth ]
    Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate
  • pH levels in umbilical vein and artery after delivery [ Time Frame: At birth ]
    Continuous variable
  • Admission to the Neonatal Intensive Care Unit [ Time Frame: Within 2 hours after birth ]
    Categorical variable, fraction of deliveries
  • Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire [ Time Frame: 4 weeks after birth ]
    Continuous variable for each category
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Duration from when the participant was given IMP, to 10 cm dilatation [ Time Frame: Up to 24 hours ]
    Time to event variable
  • Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm [ Time Frame: Up to 24 hours ]
    Continuous variable
  • Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery [ Time Frame: Up to 24 hours ]
    Time to event variable
  • Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) [ Time Frame: At birth ]
    Categorical variable
  • Vaginal delivery vs cesarean delivery [ Time Frame: At birth ]
    Categorical variable
  • Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery [ Time Frame: At birth ]
    Categorical variable
  • Amount of oxytocin given, measured 1. As total time with treatment [ Time Frame: Up to 24 hours ]
    Continuous variable
  • Amount of oxytocin given, measured 2. As International Units (IU) [ Time Frame: At birth ]
    Continuous variable
  • Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP [ Time Frame: up to 30 minutes ]
    Continuous variable
  • Postpartum hemorrhage (mL) [ Time Frame: 2 hours after birth ]
    Continuous variable
  • Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward [ Time Frame: 24 hours after birth ]
    Categorical variable
  • Anal sphincter injury [ Time Frame: At birth ]
    Categorical variable
  • Apgar score at 5 minutes and 10 minutes after delivery [ Time Frame: 5 and 10 minutes after birth ]
    Ordinal variable
  • pH levels in umbilical vein and artery after delivery [ Time Frame: At birth ]
    Continuous variable
  • Admission to the Neonatal Intensive Care Unit [ Time Frame: Within 2 hours after birth ]
    Categorical variable
  • Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire [ Time Frame: 4 weeks after birth ]
    Continuous variable for each category
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BUSCLAB - Buscopan to Prevent Slow Progress in Labor
Official Title  ICMJE BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Labor (Obstetrics)--Complications
  • Labor; Prolonged, First Stage
Intervention  ICMJE
  • Drug: Butylscopolamine Bromide 20 MG/ML
    1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
  • Drug: Sodium Chloride 9mg/mL
    1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
Study Arms  ICMJE
  • Experimental: Treatment arm
    1mL 20 mg/mL butylscopolamine bromide i.v.
    Intervention: Drug: Butylscopolamine Bromide 20 MG/ML
  • Placebo Comparator: Placebo
    1mL 9mg/mL NaCl
    Intervention: Drug: Sodium Chloride 9mg/mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Trond M Michelsen, MD, PhD +4723070000 trmi1@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961165
Other Study ID Numbers  ICMJE 2018/2380
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Trond Melbye Michelsen, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Trond M Michelsen, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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