Hyoscine Butylbromide Effect on Duration of Labor

Study Overview
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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.

Official Title
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Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial

Conditions
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Labor

Intervention / Treatment
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* Drug: Hyoscine Butylbromide 20Mg/1mL Injection
* Drug: Saline Solution


Participation Criteria
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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).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyoscine Butylbromide 20Mg/1mL Injection<br>Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms). | Drug: Hyoscine Butylbromide 20Mg/1mL Injection<br>* Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).<br>|
| Placebo Comparator: Saline solution<br>Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms). | Drug: Saline Solution<br>* Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of first stage of labor | Time measured from the moment the patient receive the allocated medication/placebo to complete dilation | 24 hours | 
| Rate of cervical dilation | Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labor | Time measured from the moment the patient receive the allocated medication/placebo to delivery | 24 hours | 
| Fetal and neonatal complications | Number of adverse events (fetal or neonatal) | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duration of labor, Hyoscine butylbromide