Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Primary Purpose
Asthma
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Health education about asthma
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring Asthma, Health education, Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant woman (less than 20 weeks of gestation at the inclusion time)
- Diagnosis of asthma before the pregnancy (clinical history and specific medications used)
- Agreement to enter into the study
Exclusion Criteria:
- Pregnant woman (more than 20 weeks of gestation at the inclusion time)
- History of major respiratory problems during previous pregnancy(ies)
- Refusal to enter into the study
Sites / Locations
- CHU St Pierre; pulmonology department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education
No education
Arm Description
Outcomes
Primary Outcome Measures
The level of asthma control
Assessment by the Asthma Control Questionnaire
Secondary Outcome Measures
Number of unscheduled visits to the doctor for asthma
Quality of life
Asthma Quality of life questionnaire
Knowledge about asthma
Survey of asthma knowledge of French language Questionnaire de connaissance de l'asthme de langue française
Full Information
NCT ID
NCT01345396
First Posted
April 28, 2011
Last Updated
April 3, 2019
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT01345396
Brief Title
Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Official Title
Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Suspended
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2015 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Health education, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Experimental
Arm Title
No education
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health education about asthma
Intervention Description
Three face-to-face appointments (<20, 36 weeks of gestation and 12 weeks after the baby birth). Topics: What is asthma? What influence the course of asthma? How to monitor it? How to manage it?
Primary Outcome Measure Information:
Title
The level of asthma control
Description
Assessment by the Asthma Control Questionnaire
Time Frame
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary Outcome Measure Information:
Title
Number of unscheduled visits to the doctor for asthma
Time Frame
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Title
Quality of life
Description
Asthma Quality of life questionnaire
Time Frame
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Title
Knowledge about asthma
Description
Survey of asthma knowledge of French language Questionnaire de connaissance de l'asthme de langue française
Time Frame
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant woman (less than 20 weeks of gestation at the inclusion time)
Diagnosis of asthma before the pregnancy (clinical history and specific medications used)
Agreement to enter into the study
Exclusion Criteria:
Pregnant woman (more than 20 weeks of gestation at the inclusion time)
History of major respiratory problems during previous pregnancy(ies)
Refusal to enter into the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Ninane, MD PhD
Organizational Affiliation
CHU St Pierre Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St Pierre; pulmonology department
City
Brussels
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Influence of an Asthma Education Programme on Asthma Control During Pregnancy
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