BUSCLAB - Buscopan to Prevent Slow Progress in Labor
- Conditions
- Labor; Prolonged, First StageLabor (Obstetrics)--Complications
- Interventions
- Drug: Sodium Chloride 9mg/mL
- Registration Number
- NCT03961165
- Lead Sponsor
- Oslo University Hospital
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 250
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm Butylscopolamine Bromide 20 MG/ML 1mL 20 mg/mL butylscopolamine bromide i.v. Placebo Sodium Chloride 9mg/mL 1mL 9mg/mL NaCl
- Primary Outcome Measures
Name Time Method Duration of labor from the time when the participant was given IMP to delivery Up to 24 hours Time to event variable
- Secondary Outcome Measures
Name Time Method Duration from when the participant was given IMP, to 10 cm dilatation Up to 24 hours Time to event variable
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm Up to 24 hours Continuous variable
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery Up to 24 hours Time to event variable
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) At birth Categorical variable, fraction of all deliveries
Vaginal delivery vs cesarean delivery At birth Categorical variable, fraction of all deliveries
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery At birth Categorical variable, fraction of all deliveries
Amount of oxytocin given, measured 1. As total time with treatment Up to 24 hours Continuous variable, minutes
Amount of oxytocin given, measured 2. As International Units (IU) At birth Continuous variable
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP up to 30 minutes Continuous variable, scale 1 to 9, where 9 is most severe pain
Postpartum hemorrhage (mL) 2 hours after birth Continuous variable
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward 24 hours after birth Categorical variable, fraction of women with urinary retention
Anal sphincter injury At birth Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries
Apgar score at 5 minutes and 10 minutes after delivery 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 At birth Continuous variable
Admission to the Neonatal Intensive Care Unit Within 2 hours after birth Categorical variable, fraction of deliveries
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire 4 weeks after birth Continuous variable for each category
Trial Locations
- Locations (1)
Oslo University Hospital Rikshospitalet
🇳🇴Oslo, Norway