Hyoscine Butylbromide Effect on Duration of Labor

Not Applicable

Completed

• Conditions: Labor
• Interventions: Drug: Saline Solution; Drug: Hyoscine Butylbromide 20Mg/1mL Injection

• Registration Number: NCT03441217
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Study Start: 2019-07-12
• Primary Completion: 2019-08-30
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution	Saline Solution	Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).
Hyoscine Butylbromide 20Mg/1mL Injection	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).

Primary Outcome Measures

Name	Time	Method
Duration of first stage of labor	24 hours	Time measured from the moment the patient receive the allocated medication/placebo to complete dilation
Rate of cervical dilation	24 hours	Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation

Secondary Outcome Measures

Name	Time	Method
Duration of labor	24 hours	Time measured from the moment the patient receive the allocated medication/placebo to delivery
Fetal and neonatal complications	72 hours	Number of adverse events (fetal or neonatal)

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama