Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
180 participants
INTERVENTIONAL
2014-04-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Hyoscine bromide
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
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).
Physiological serum
100 ml of physiological serum (0.9% NaCl).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of risk factors.
* Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Montse Palacio
MD, PhD.
Principal Investigators
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Montse Palacio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Mariona Rius, MD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Ana Sandra Hernandez, MD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Irene Teixido, MD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Irene Vives, MD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Midwives Collaborative Group HCP
Role: STUDY_CHAIR
Hospital Clínic
Locations
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Hospital Clínic
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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2013-001921-19
Identifier Type: -
Identifier Source: org_study_id
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