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CompletedNCT03441217Updated Dec 6, 2019

Hyoscine Butylbromide Effect on Duration of Labor

An interventional study of Hyoscine Butylbromide 20Mg/1mL Injection and Saline Solution in Labor, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2019-12-06.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Labor

Keywords

  • Duration of labor
  • Hyoscine butylbromide
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Low risk gestation between 37 and 41 6/7 weeks.
  • Cephalic (vertex) presentation.
  • Spontaneous labor in active phase (4 cms)

Exclusion criteria

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    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).

    Drug: Hyoscine Butylbromide 20Mg/1mL Injection

  • Placebo comparator
    Saline solution

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

    Drug: Saline Solution

Interventions

  • DrugHyoscine 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).

  • DrugSaline Solution

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

05

What researchers measure

Primary outcomes

  1. Duration of first stage of labor

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

    Time frame: 24 hours

  2. Rate of cervical dilation

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

    Time frame: 24 hours

Secondary outcomes

  1. Duration of labor

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

    Time frame: 24 hours

  2. Fetal and neonatal complications

    Number of adverse events (fetal or neonatal)

    Time frame: 72 hours

06

Study locations

1 site
  • Saint Thomas Maternity Hospital
    Panama, Panama
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03441217
Lead sponsor
Saint Thomas Hospital, Panama
Collaborators
Sistema Nacional de Investigadores de Panamá
Responsible party
Osvaldo A. Reyes T. (Head - Research Department, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Feb 22, 2018
Start date
Jul 12, 2019
Primary completion
Aug 30, 2019
Completion
Nov 30, 2019
Last update
Dec 6, 2019

Study contacts

Osvaldo Reyes, MD
study director · Maternidad del Hospital Santo Tomás

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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