BUSCLAB - Buscopan to Prevent Slow Progress in Labor

Labor (Obstetrics)--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961165
• Other study ID #: 2018/2380
• Status: Completed
• Phase: Phase 3
• Start date: May 25, 2019
• Est. completion date: June 16, 2022

Study information

• Verified date: December 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 16, 2022
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Butylscopolamine Bromide 20 MG/ML
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
• Sodium Chloride 9mg/mL
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.

Locations

Country	Name	City	State
Norway	Oslo University Hospital Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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