Role of Hyoscine Bromide in Latent and Active Labor

NCT ID: NCT02103166

Last Updated: 2016-08-19

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-04-30

Brief Summary

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

Detailed Description

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Conditions

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Labor, First Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hyoscine bromide

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

Group Type EXPERIMENTAL

Hyoscine bromide

Intervention Type DRUG

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).

Group Type PLACEBO_COMPARATOR

Physiological serum

Intervention Type DRUG

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).

Intervention Type DRUG

Physiological serum

100 ml of physiological serum (0.9% NaCl).

Intervention Type DRUG

Other Intervention Names

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Buscapina Saline serum

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Montse Palacio

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Spain

Other Identifiers

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2013-001921-19

Identifier Type: -

Identifier Source: org_study_id

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