Labor (Obstetrics)--Complications, Labor; Prolonged, First Stage
Conditions
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.
Interventions
DRUGButylscopolamine Bromide 20 MG/ML
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of labor from the time when the participant was given IMP to delivery | Up to 24 hours | Time to event variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Norway
Outcome results
None listed