Hyoscine Butylbromide Effect on Duration of Labor

NCT03441217 — Not applicable, Completed, 218 participants, Saint Thomas Hospital, Panama

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03441217
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	218 (Actual)
Sponsor	Saint Thomas Hospital, Panama (Other); collaborators: Sistema Nacional de Investigadores de Panamá
Conditions	Labor
Interventions	Hyoscine Butylbromide 20Mg/1mL Injection, Saline Solution (Drug)
Dates	start 2019-07-12, primary completion 2019-08-30, completion 2019-11-30, first posted 2018-02-22, last updated 2019-12-06
Locations	1 site in Panama

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Hyoscine Butylbromide 20Mg/1mL Injection	Experimental	Drug: 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).
Saline solution	Placebo comparator	Drug: 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 (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 (Drug): Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: Female

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).

+Locations (1)

Facility	City	Country	Status
Saint Thomas Maternity Hospital	Panama City	Panama

+Investigators

Osvaldo Reyes, MD, Study director, Maternidad del Hospital Santo Tomás

My Notes

Public

To Read Reading Read