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Role of Hyoscine Bromide in Latent and Active Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103166
Recruitment Status : Suspended (Conditions of recruitment changed)
First Posted : April 3, 2014
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Montse Palacio, 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.

Condition or disease Intervention/treatment Phase
Labor, First Stage Drug: Hyoscine bromide Drug: Physiological serum Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : April 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Saline serum




Primary Outcome Measures :
  1. Time to complete dilation [ Time Frame: One hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103166


Locations
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Spain
Hospital Clínic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Montse Palacio, MD, PhD Hospital Clínic de Barcelona
Study Chair: Mariona Rius, MD Hospital Clínic de Barcelona
Study Chair: Ana Sandra Hernandez, MD Hospital Clínic de Barcelona
Study Chair: Irene Teixido, MD Hospital Clínic de Barcelona
Study Chair: Irene Vives, MD Hospital Clínic de Barcelona
Study Chair: Midwives Collaborative Group HCP Hospital Clínic

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Responsible Party: Montse Palacio, MD, PhD., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02103166    
Other Study ID Numbers: 2013-001921-19
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Scopolamine
Bromides
Butylscopolammonium Bromide
Anticonvulsants
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics