FindTrial
Sign In

use of hyoscine bromide in labor

Randomised, masked, placebo-controlled study to evaluate the effects of a single intravenous dose of hyoscine bromide on the duration and pain in the latent and active labor

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001921-19-ES
Enrollment
Unknown
Registered
2014-01-16
Start date
2014-02-11
Completion date
Unknown
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor MedDRA version: 16.1 Level: PT Classification code 10029767 Term: Normal labour System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Buscapina Product Name: Buscapina Pharmaceutical Form: Solution for injection INN or Proposed INN: Buscapina CAS Number: 149-64-4 Other descriptive name: HYOSCINE BUTYLBROMIDE Concentratio

Sponsors

Fundació Clínic per a la Recerca Biomèdica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 18 years or more Only at term pregnancy cephalic No oxytocin augmentation present at the time of inclusion. Dynamic uterine established. Absence of risk factors high or very high by Generalitat de Catalunya Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Induction of labor Risk factors (preeclampsia, severe maternal disease, fetal pathology) Patients with hypersensitivity to active substance or to any of the excipients or any contraindication reflected in the Summary of buscapine characteristics

Design outcomes

Primary

MeasureTime frame
Main Objective: Demosntrate if hyoscine bromide reduces the duration of the first active phase of labor.;Secondary Objective: Demonstrate if pain or analgesic requirement decrease with hyoscine bromide use in those patients without epidural analgesia. Demonstrate whether the effect of hyoscine bromide differs between primiparous or multiparous.;Primary end point(s): Time to complete dilatation (continuous);Timepoint(s) of evaluation of this end point: labour—

Secondary

MeasureTime frame
Secondary end point(s): VAS at 2, 4, 6h, if epidural anesthesia Epidural anesthesia Time to epidural anesthesia The need for oxytocin augmentation Type of labor Time of delivery Neonatal weight Apgar 5 and 10 minutes PH arterial and venous umbilical cord Admission in intensive care unit;Timepoint(s) of evaluation of this end point: labor—

Countries

Spain

Contacts

Public ContactCTU CLINIC

Clinical Trials Unit- Hospital Clinic of Barcelona

svarea@clinic.ub.es00349322754003343

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026