To study the effect of Butylscopolamide Bromide on duration of the active phase of first stage of labor in women who cross the alert-line for labor dystocia, according to the WHO partograph.
Conditions
Interventions
Trade Name: Buscopan
Product Name: Buscopan
Product Code: A03BB01
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions must apply to the prospective patient at screening prior to receiving study agent (e.g.): • =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 labor (cervix dilation =3 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following 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 • Previous major uterine surgery • 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) • Untreated glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of Butylscopolamide 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. ;Secondary Objective: Duration of labor from the time when the participant was given IMP to delivery Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery Amount of oxytocin given, measured 1. As total time with treatment 2. As International Units (IU). The midwife measures mL of oxytocin solution given during labor. IU are calculated based on standardized concentration of the infusion solution [10 IU oxytocin in 1000 mL NaCl solution]. Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP Apgar score at 1 minute, 5 minutes and 10 minutes after delivery pH levels in umbilical vein and artery after delivery Admission to the Neonatal Intensive Care Unit Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire ;Primary end point(s): Primary endpoint: Duration from when the participant was given IMP, to 10 cm dilatation;Timepoint(s) of evaluation of this end point: The time from IMP to 10 cm dilatation will be determined when the participant reaches 10 cm dilatation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of labor from the time when the participant was given IMP to delivery Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery Amount of oxytocin given, measured 1. As total time with treatment 2. As International Units (IU). The midwife measures mL of oxytocin solution given during labor. IU are calculated based on standardized concentration of the infusion solution [10 IU oxytocin in 1000 mL NaCl solution]. Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP Apgar score at 1 minute, 5 minutes and 10 minutes after delivery pH levels in umbilical vein and artery after delivery Admission to the Neonatal Intensive Care Unit Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire ;Timepoint(s) of evaluation of this end point: Duration of labor from IMP to delivery: at delivery Duration of labor from the onset of active labor to delivery: at delivery Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery: at delivery Amount of oxytocin given: determined after labor Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP Apgar score at 1 minute, 5 minutes and 10 minutes after delivery pH levels in umbilical vein and artery after delivery Admission to the Neonatal Intensive Care Unit: after the hospital stay Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire: 1-2 months post partum | — |
Countries
Norway
Contacts
Public ContactDept of Obstetrics Rikshospitalet
Oslo University Hospital
Outcome results
None listed