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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
250
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
Oslo University Hospital Rikshospitalet
Oslo, Norway
Duration of labor from the time when the participant was given IMP to delivery
Time to event variable
Time frame: Up to 24 hours
Duration from when the participant was given IMP, to 10 cm dilatation
Time to event variable
Time frame: Up to 24 hours
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm
Continuous variable
Time frame: Up to 24 hours
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Time to event variable
Time frame: Up to 24 hours
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)
Categorical variable, fraction of all deliveries
Time frame: At birth
Vaginal delivery vs cesarean delivery
Categorical variable, fraction of all deliveries
Time frame: At birth
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Categorical variable, fraction of all deliveries
Time frame: At birth
Amount of oxytocin given, measured 1. As total time with treatment
Continuous variable, minutes
Time frame: Up to 24 hours
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Amount of oxytocin given, measured 2. As International Units (IU)
Continuous variable
Time frame: At birth
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP
Continuous variable, scale 1 to 9, where 9 is most severe pain
Time frame: up to 30 minutes
Postpartum hemorrhage (mL)
Continuous variable
Time frame: 2 hours after birth
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward
Categorical variable, fraction of women with urinary retention
Time frame: 24 hours after birth
Anal sphincter injury
Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries
Time frame: At birth
Apgar score at 5 minutes and 10 minutes after delivery
Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate
Time frame: 5 and 10 minutes after birth
pH levels in umbilical vein and artery after delivery
Continuous variable
Time frame: At birth
Admission to the Neonatal Intensive Care Unit
Categorical variable, fraction of deliveries
Time frame: Within 2 hours after birth
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
Continuous variable for each category
Time frame: 4 weeks after birth