BUSCLAB - Buscopan to Prevent Slow Progress in Labor

Study Overview
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Brief Summary
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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.

Official Title
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BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor

Conditions
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Labor (Obstetrics)--Complications, Labor; Prolonged, First Stage

Intervention / Treatment
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* Drug: Butylscopolamine Bromide 20 MG/ML
* Drug: Sodium Chloride 9mg/mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>1mL 20 mg/mL butylscopolamine bromide i.v. | Drug: Butylscopolamine Bromide 20 MG/ML<br>* 1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.<br>|
| Placebo Comparator: Placebo<br>1mL 9mg/mL NaCl | Drug: Sodium Chloride 9mg/mL<br>* 1 mL Sodium Chloride 9 mg/mL i.v. Single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labor from the time when the participant was given IMP to delivery | Time to event variable | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration from when the participant was given IMP, to 10 cm dilatation | Time to event variable | Up to 24 hours | 
| Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm | Continuous variable | Up to 24 hours | 
| Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery | Time to event variable | Up to 24 hours | 
| Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) | Categorical variable, fraction of all deliveries | At birth | 
| Vaginal delivery vs cesarean delivery | Categorical variable, fraction of all deliveries | At birth | 
| Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery | Categorical variable, fraction of all deliveries | At birth | 
| Amount of oxytocin given, measured 1. As total time with treatment | Continuous variable, minutes | Up to 24 hours | 
| Amount of oxytocin given, measured 2. As International Units (IU) | Continuous variable | 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 | up to 30 minutes | 
| Postpartum hemorrhage (mL) | Continuous variable | 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 | 24 hours after birth | 
| Anal sphincter injury | Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries | 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 | 5 and 10 minutes after birth | 
| pH levels in umbilical vein and artery after delivery | Continuous variable | At birth | 
| Admission to the Neonatal Intensive Care Unit | Categorical variable, fraction of deliveries | Within 2 hours after birth | 
| Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire | Continuous variable for each category | 4 weeks after birth |