Clinical trial NCT03961165: BUSCLAB - Buscopan to Prevent Slow Progress in Labor
Official title: BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor (Obstetrics)--Complications
Labor; Prolonged, First Stage
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Duration of labor from the time when the participant was given IMP to delivery
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Duration from when the participant was given IMP, to 10 cm dilatation
timeFrame: Up to 24 hours
measure: Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm
timeFrame: Up to 24 hours
measure: Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
timeFrame: Up to 24 hours
measure: Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)
timeFrame: At birth
measure: Vaginal delivery vs cesarean delivery
timeFrame: At birth
measure: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
timeFrame: At birth
measure: Amount of oxytocin given, measured 1. As total time with treatment
timeFrame: Up to 24 hours
measure: Amount of oxytocin given, measured 2. As International Units (IU)
timeFrame: At birth
measure: Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP
timeFrame: up to 30 minutes
measure: Postpartum hemorrhage (mL)
timeFrame: 2 hours after birth
measure: Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward
timeFrame: 24 hours after birth
measure: Anal sphincter injury
timeFrame: At birth
measure: Apgar score at 5 minutes and 10 minutes after delivery
timeFrame: 5 and 10 minutes after birth
measure: pH levels in umbilical vein and artery after delivery
timeFrame: At birth
measure: Admission to the Neonatal Intensive Care Unit
timeFrame: Within 2 hours after birth
measure: Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
timeFrame: 4 weeks after birth
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Trond M Michelsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: