BUSCLAB - Buscopan to Prevent Slow Progress in Labor

University of Oslo (UIO)

Status and phase

Completed

Phase 3

Conditions

Labor (Obstetrics)--Complications

Labor; Prolonged, First Stage

Treatments

Drug: Sodium Chloride 9mg/mL

Drug: Butylscopolamine Bromide 20 MG/ML

Study type

Interventional

Funder types

Other

Identifiers

NCT03961165

2018/2380

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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