Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Feb 2010
Longer than P75 for not_applicable asthma
1 active site
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
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 4, 2019
April 1, 2019
3 years
April 28, 2011
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The level of asthma control
Assessment by the Asthma Control Questionnaire
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary Outcomes (3)
Number of unscheduled visits to the doctor for asthma
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Quality of life
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Knowledge about asthma
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Study Arms (2)
Education
EXPERIMENTALNo education
NO INTERVENTIONInterventions
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?
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma before the pregnancy (clinical history and specific medications used)
- Agreement to enter into the study
You may not qualify if:
- History of major respiratory problems during previous pregnancy(ies)
- Refusal to enter into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU St Pierre; pulmonology department
Brussels, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Ninane, MD PhD
CHU St Pierre Brussels
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. V. Ninane
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 2, 2011
Study Start
February 1, 2010
Primary Completion
February 1, 2013
Study Completion
December 1, 2015
Last Updated
April 4, 2019
Record last verified: 2019-04