Hyoscine Butylbromide Effect on Duration of Labor

Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441217
• Other study ID #: MHST2014-05
• Status: Completed
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Labor

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (2)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama	Sistema Nacional de Investigadores de Panamá

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of first stage of labor	Time measured from the moment the patient receive the allocated medication/placebo to complete dilation	24 hours
Primary	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	Duration of labor	Time measured from the moment the patient receive the allocated medication/placebo to delivery	24 hours
Secondary	Fetal and neonatal complications	Number of adverse events (fetal or neonatal)	72 hours