NCT03441217

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

February 13, 2018

Last Update Submit

December 5, 2019

Conditions

Labor

Keywords

Duration of laborHyoscine butylbromide

Outcome Measures

Primary Outcomes (2)

  • Duration of first stage of labor

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

    24 hours

  • 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 Outcomes (2)

  • Duration of labor

    24 hours

  • Fetal and neonatal complications

    72 hours

Study Arms (2)

Hyoscine Butylbromide 20Mg/1mL Injection

EXPERIMENTAL

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

Saline solution

PLACEBO COMPARATOR

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

Hyoscine Butylbromide 20Mg/1mL InjectionDRUG

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

Hyoscine Butylbromide 20Mg/1mL Injection
Saline SolutionDRUG

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

Saline solution

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Interventions

Butylscopolammonium BromideInjectionsSaline Solution

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingDrug Administration RoutesDrug TherapyTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Osvaldo Reyes, MD

    Maternidad del Hospital Santo Tomás

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head - Research Department

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 22, 2018

Study Start

July 12, 2019

Primary Completion

August 30, 2019

Study Completion

November 30, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)