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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05904002
Other study ID # Eman_Amin_2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2020
Est. completion date February 15, 2022

Study information

Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.


Description:

This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 15, 2022
Est. primary completion date September 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 40 Years
Eligibility Inclusion Criteria: The patients will have the following criteria: 1. Their age will range from 30 to40years old. 2. Body mass index (BMI) will range from 25-29.9 kg/m2. 3. All patients will be clinically and medically stable. Exclusion Criteria: Patients will be excluded from the study if they have the following: 1. Diabetes mellitus. 2. Severe hypertension. 3. Neurological and neuromuscular disorders. 4. Blindness. 5. Developed moderate and severe degree of pleural effusion. 6. Cardiovascular instability. 7. Chronic chest disease.

Study Design


Intervention

Drug:
pulmicort inhaler
Each woman in both groups (A&B) will receive pulmicort inhaler on needs.
Device:
Incentive spirometer treatment
Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.

Locations

Country Name City State
Egypt Outpatient clinic faculty of physical therapy cairo university Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the change in lung functions The spirometer will be used for assessment of lung functions including total lung capacity (TLC) (litre), which is the most widely used functional index in the asthma follow up. at baseline and after 6 weeks of intervention
Primary Assessing the change in symptoms of asthma The Asthma Control Test provides a numerical score to help you and your healthcare provider determine if your asthma symptoms are well controlled. Take this test if you are 12 years or older. Share the score with your healthcare provider. at baseline and after 6 weeks of intervention
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