Role of Hyoscine Bromide in Latent and Active Labor

Labor, First Stage Clinical Trial

Official title:

Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02103166
• Other study ID #: 2013-001921-19
• Status: Suspended
• Phase: Phase 4
• First received: April 1, 2014
• Last updated: August 18, 2016
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 180
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age: 18 or more.

• Term pregnancy.

• Cephalic presentation.

• Oxytocin perfusion not present at the time of inclusion.

• Uterine dynamic established.

• Abscence of high risk factors or very high risk factors for pregnancy.

• Written informed consent

Exclusion Criteria:

• Induction of labor.

• Presence of risk factors.

• Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Labor, First Stage

Intervention

Drug:
• Hyoscine bromide
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
• Physiological serum
100 ml of physiological serum (0.9% NaCl).

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete dilation		One hour	No