Role of Hyoscine Bromide in Latent and Active Labor

Phase 4

Suspended

• Conditions: Labor, First Stage
• Interventions: Drug: Hyoscine bromide; Drug: Physiological serum

• Registration Number: NCT02103166
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyoscine bromide	Hyoscine bromide	20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
Physiological serum	Physiological serum	100 ml of physiological serum (0.9% NaCl).

Primary Outcome Measures

Name	Time	Method
Time to complete dilation	One hour

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain