Role of Hyoscine Bromide in Latent and Active Labor

Hospital Clinic of Barcelona

Status and phase: Suspended; Phase 4

Conditions: Labor, First Stage

Treatments: Drug: Hyoscine bromide; Drug: Physiological serum

Study type: Interventional

Funder types: Other

Identifiers

NCT02103166

2013-001921-19

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

180 participants in 2 patient groups, including a placebo group

Hyoscine bromide

Experimental group

Description:

20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).

Treatment:

Drug: Hyoscine bromide

Physiological serum

Placebo Comparator group

Description:

100 ml of physiological serum (0.9% NaCl).

Treatment:

Drug: Physiological serum