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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01345396
Other study ID # B07620096465
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date February 2010
Est. completion date December 2015

Study information

Verified date April 2019
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 80
Est. completion date December 2015
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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?

Locations

Country Name City State
Belgium CHU St Pierre; pulmonology department Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The level of asthma control Assessment by the Asthma Control Questionnaire Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary Number of unscheduled visits to the doctor for asthma Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary Quality of life Asthma Quality of life questionnaire Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary Knowledge about asthma Survey of asthma knowledge of French language Questionnaire de connaissance de l'asthme de langue française Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
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