Influence of an Asthma Education Programme on Asthma Control During Pregnancy

April 3, 2019 updated by: Vincent Ninane, Centre Hospitalier Universitaire Saint Pierre

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • CHU St Pierre; pulmonology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of asthma control
Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Assessment by the Asthma Control Questionnaire
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unscheduled visits to the doctor for asthma
Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Quality of life
Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Asthma Quality of life questionnaire
Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Knowledge about asthma
Time Frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Vincent Ninane, MD PhD, CHU St Pierre Brussels

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion

December 1, 2015

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (ESTIMATE)

May 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B07620096465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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