Influence of an Asthma Education Programme on Asthma Control During Pregnancy
This study is currently recruiting participants.
Verified October 2012 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01345396
First received: April 28, 2011
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Behavioral: Health education about asthma |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:
Primary Outcome Measures:
- The level of asthma control [ Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum ] [ Designated as safety issue: No ]Assessment by the Asthma Control Questionnaire
Secondary Outcome Measures:
- Number of unscheduled visits to the doctor for asthma [ Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum ] [ Designated as safety issue: No ]Asthma Quality of life questionnaire
- Knowledge about asthma [ Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum ] [ Designated as safety issue: No ]Survey of asthma knowledge of French language Questionnaire de connaissance de l'asthme de langue française
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Education |
Behavioral: Health education about asthma
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?
|
| No Intervention: No education |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345396
Contacts
| Contact: Francois Vermeulen, PT | +3225353727 | vermeulenfr@yahoo.com |
| Contact: Vincent Ninane, MD | +3225354276 | Vincent_Ninane@stpierre-bru.be |
Locations
| Belgium | |
| CHU St Pierre; pulmonology department | Recruiting |
| Brussels, Belgium | |
| Contact: Francois Vermeulen, PT +3225353727 | |
| Contact: Vincent Ninane, MD +3225354276 Vincent_Ninane@stpierre-bru.be | |
| Principal Investigator: Francois Vermeulen, PT | |
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
| Principal Investigator: | Francois Vermeulen, PT | CHU St Pierre Brussels |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire Saint Pierre |
| ClinicalTrials.gov Identifier: | NCT01345396 History of Changes |
| Other Study ID Numbers: | B07620096465 |
| Study First Received: | April 28, 2011 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
|
Asthma Health education Pregnancy |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013