NCT02106000

Brief Summary

The purpose of this study is to record and compare the inhalation profiles of non pregnant women and those who are in the third stage of labour. The inhalation profiles will be recorded from consenting women as they inhale with maximal effort through an inhalation profile recorder \[Glaxosmithkline (GSK), Ware\]. The recorder will simulate resistance to airflow and will be representative of a dry powder inhaler of moderate resistivity. The inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be compared between the two female cohorts. Inhalation profiles recorded in this way may subsequently be used to study the in-vitro performance of investigational materials across inhalation parameters representative of the target patient population. An appropriate number of subjects will be consented so that approximately 40 subjects (20 non-pregnant females and 20 stage three labour subjects) complete assessments. The inhalation profiles will be recorded on the same day of screening or at another time within a span of 50 days

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 24, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2014

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

April 3, 2014

Last Update Submit

May 23, 2017

Conditions

Haemorrhage

Keywords

Post PartumInhaled OxytocinInhalation Profiles

Outcome Measures

Primary Outcomes (12)

  • Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out by measuring the Peak pressure Drop (kPa) using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of non-pregnant women by measuring Peak Inspiratory Flow Rate

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for Peak Inspiratory Flow Rate \[Liters/minute (L/min)\] using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of non-pregnant women by measuring Inhaled Volume

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for the Inhaled Volume (L) using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of non-pregnant women by measuring Inhalation time

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for the Inhalation time measured in seconds(s)

    Screening, Up to Day 50

  • Characterization of the inhalation profile of non-pregnant women by measuring Average Inhalation Flow Rate

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment will be carried out for Average Inhalation Flow Rate (L/min) measured using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of non-pregnant women by measuring Acceleration rate

    Up to three inhalation profiles will be recorded in the semi-supine position and the assessment of Acceleration rate (L/min/s) will be measured using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak pressure Drop

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out by measuring the Peak pressure Drop (kPa) using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak Inspiratory Flow Rate

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for Peak Inspiratory Flow Rate (L/min) using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhaled Volume

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for the Inhaled Volume (L) using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhalation time

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for the Inhalation time measured in seconds

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Average Inhalation Flow Rate

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment will be carried out for Average Inhalation Flow Rate (L/min) measured using the inhalation profile recorder

    Screening, Up to Day 50

  • Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Acceleration rate

    Up to three inhalation profiles will be recorded in a comfortable position (the position will be recorded) and the assessment of Acceleration rate (L/min/s) will be measured using the inhalation profile recorder

    Screening, Up to Day 50

Study Arms (2)

Arm 1: Non-pregnant females

Inhalation profiles will be recorded for non-pregnant females

Device: Inhalation profile recorder

Arm 2: Pregnant females

Inhalation profiles will be recorded for the women in the 3rd stage of labour

Device: Inhalation profile recorder

Interventions

Inhalation profile recorderDEVICE

Up to three inhalation profiles will be recorded whilst inhaling with maximal effort

Arm 1: Non-pregnant femalesArm 2: Pregnant females

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women: pregnant and non-pregnant non-pregnant female subject is eligible to participate in the study if she is in the age group of 18 to 30 years pregnant female will be eligible to participate in the study if she belongs to the age group of 18 to 30 years

You may not qualify if:

  • Healthy Volunteers will be excluded from the study if they have a history or regular use of tobacco or smoking products within 6 months prior to screening; have a current history of Asthma or history of lung disease; have a history of Airway obstruction or abnormality OR have an upper or lower respiratory tract infection within four weeks of the inhalation assessment visit.
  • Pregnant Females will be excluded from the study if they are undergoing Caesarean Section; OR have preeclampsia; have an upper or lower respiratory tract infection within four weeks of the inhalation assessment visit; are receiving an epidural or opioid analgesia for pain management; OR require instrumental or otherwise assisted delivery as assessed by the midwife staff at time of inhalation assessment visit OR have a current history of asthma or lung disease ; have a history of airway obstruction or abnormality; OR have a history or regular use of tobacco or smoking products within 6 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Cambridge, CB2 0SW, United Kingdom

Location

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 7, 2014

Study Start

June 24, 2014

Primary Completion

December 20, 2014

Study Completion

December 20, 2014

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

GB(2)