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Completed

NCT Number: NCT03441217

Hyoscine Butylbromide Effect on Duration of Labor

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.

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Key information

Conditions

Labor

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Maternity Hospital

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. Duration of first stage of labor

    Time frame: 24 hours

    Time measured from the moment the patient receive the allocated medication/placebo to complete dilation

  2. Rate of cervical dilation

    Time frame: 24 hours

    Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation

Secondary outcomes

  1. Duration of labor

    Time frame: 24 hours

    Time measured from the moment the patient receive the allocated medication/placebo to delivery

  2. Fetal and neonatal complications

    Time frame: 72 hours

    Number of adverse events (fetal or neonatal)

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Collaborators

  • Sistema Nacional de Investigadores de Panamá

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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