Influence of an Asthma Education Programme on Asthma Control During Pregnancy

Asthma Clinical Trial

Official title:

Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01345396
• Other study ID #: B07620096465
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Asthma

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