Hyoscine Butylbromide Effect on Duration of Labor

NCT ID: NCT03441217

Last Updated: 2019-12-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2019-11-30

Brief Summary

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To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.

Detailed Description

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Conditions

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Labor

Keywords

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Duration of labor Hyoscine butylbromide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Group Type EXPERIMENTAL

Hyoscine Butylbromide 20Mg/1mL Injection

Intervention Type DRUG

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).

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Low risk gestation between 37 and 41 6/7 weeks.
* Cephalic (vertex) presentation.
* Spontaneous labor in active phase (4 cms)

Exclusion Criteria

* Premature rupture of membranes upon arrival at the Labor and Delivery Unit \> 4 hours.
* Multiple order pregnancy.
* Stillbirth.
* Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sistema Nacional de Investigadores de Panamá

UNKNOWN

Sponsor Role collaborator

Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head - Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Panama

Other Identifiers

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MHST2014-05

Identifier Type: -

Identifier Source: org_study_id