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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COMPLETED
NA
218 participants
INTERVENTIONAL
2019-07-12
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms).
Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).
Saline solution
Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).
Saline Solution
Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).
Interventions
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Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).
Saline Solution
Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).
Eligibility Criteria
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Inclusion Criteria
* Cephalic (vertex) presentation.
* Spontaneous labor in active phase (4 cms)
Exclusion Criteria
* Multiple order pregnancy.
* Stillbirth.
* Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
FEMALE
No
Sponsors
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Sistema Nacional de Investigadores de Panamá
UNKNOWN
Saint Thomas Hospital, Panama
OTHER
Responsible Party
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Osvaldo A. Reyes T.
Head - Research Department
Principal Investigators
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Osvaldo Reyes, MD
Role: STUDY_DIRECTOR
Maternidad del Hospital Santo Tomás
Locations
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Saint Thomas Maternity Hospital
Panama City, , Panama
Countries
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Other Identifiers
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MHST2014-05
Identifier Type: -
Identifier Source: org_study_id