Hyoscine Butylbromide Effect on Duration of Labor

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Labor

Treatments: Drug: Saline Solution; Drug: Hyoscine Butylbromide 20Mg/1mL Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03441217

MHST2014-05

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

Hyoscine Butylbromide 20Mg/1mL Injection

Experimental group

Description:

Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms).

Treatment:

Drug: Hyoscine Butylbromide 20Mg/1mL Injection

Saline solution

Placebo Comparator group

Description:

Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).

Treatment:

Drug: Saline Solution