Influence of an Asthma Education Programme on Asthma Control During Pregnancy

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Vincent Ninane, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01345396
First received: April 28, 2011
Last updated: October 11, 2013
Last verified: October 2013
  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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01345396

Locations
Belgium
CHU St Pierre; pulmonology department
Brussels, Belgium
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Vincent Ninane, MD PhD CHU St Pierre Brussels
  More Information

No publications provided

Responsible Party: Vincent Ninane, Prof. Dr. V. Ninane, 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 11, 2013
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 August 27, 2014