Role of Hyoscine Bromide in Latent and Active Labor

August 18, 2016 updated by: Montse Palacio, Hospital Clinic of Barcelona

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hyoscine bromide
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
Drug: Hyoscine bromide
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
Other Names:
  • Buscapina
PLACEBO_COMPARATOR: Physiological serum
100 ml of physiological serum (0.9% NaCl).
Drug: Physiological serum
100 ml of physiological serum (0.9% NaCl).
Other Names:
  • Saline serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to complete dilation
Time Frame: One hour
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona
  • Study Chair: Mariona Rius, MD, Hospital Clinic of Barcelona
  • Study Chair: Ana Sandra Hernandez, MD, Hospital Clinic of Barcelona
  • Study Chair: Irene Teixido, MD, Hospital Clinic of Barcelona
  • Study Chair: Irene Vives, MD, Hospital Clinic of Barcelona
  • Study Chair: Midwives Collaborative Group HCP, Hospital Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (ESTIMATE)

April 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-001921-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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