Haemorrhage
Conditions
Keywords
Post Partum, Inhaled Oxytocin, Inhalation Profiles
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
Interventions
DEVICEInhalation profile recorder
Up to three inhalation profiles will be recorded whilst inhaling with maximal effort
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* A non-pregnant female subject is eligible to participate in the study if she is in the age group of 18 to 30 years (inclusive), at the time of signing the informed consent; is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history; is having a body weight \>= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 - 29.9 kg/meter\^2 (inclusive); is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; OR is having a clinical abnormality which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures * Pregnant Female will be eligible to participate in the study if she belongs to the age group of 18 to 30 years (inclusive), at the time of signing the informed consent; is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history; is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form ;OR is having a clinical abnormality which is/are not specifically listed in the inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of the inhalation profile of non-pregnant women by measuring Peak pressure drop | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of non-pregnant women by measuring Peak Inspiratory Flow Rate | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of non-pregnant women by measuring Inhaled Volume | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of non-pregnant women by measuring Inhalation time | Screening, Up to Day 50 | 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) |
| Characterization of the inhalation profile of non-pregnant women by measuring Average Inhalation Flow Rate | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of non-pregnant women by measuring Acceleration rate | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak pressure Drop | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Peak Inspiratory Flow Rate | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhaled Volume | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Inhalation time | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Average Inhalation Flow Rate | Screening, Up to Day 50 | 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 |
| Characterization of the inhalation profile of women in the 3rd stage of labour by measuring Acceleration rate | Screening, Up to Day 50 | 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 |
Countries
United Kingdom
Outcome results
None listed