Skip to main content
OpenTrials
Completed

NCT Number: NCT03961165

BUSCLAB - Buscopan to Prevent Slow Progress in Labor

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butylscopolamine Bromide 20 MG/ML

Drug

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

Sodium Chloride 9mg/mL

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 23, 2019
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.