AsthmaNCT01345396
Influence of an Asthma Education Programme on Asthma Control During Pregnancy
A study testing Health education about asthma in people with Asthma, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Health education about asthma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Health education about asthma
- Keywords
- Asthma, Health education, Pregnancy
- Medical subject headings
- Asthma, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education about asthmaBehavioural
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?
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Not described Receives: Behavioral: Health education about asthma |
| No education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of asthma control
Assessment by the Asthma Control Questionnaire
Measured: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Secondary outcomes (3)
Number of unscheduled visits to the doctor for asthma
Measured: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Quality of life
Asthma Quality of life questionnaire
Measured: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Knowledge about asthma
Survey of asthma knowledge of French language Questionnaire de connaissance de l'asthme de langue française
Measured: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Ninane, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Vincent Ninane, MD PhD, Principal investigator, CHU St Pierre Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345396
- Sponsor's protocol ID
- B07620096465
- Status last verified
- Apr 2019
- First submitted
- 28 Apr 2011
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Educational Programme for Pregnant Asthmatic Women on the Level of Asthma Control and Unscheduled Doctor Visits During the Pregnancy
- ClinicalTrials.gov ID
- NCT01345396
- Acronym / sponsor ID
- B07620096465
- Conditions
- Asthma
- Keywords
- Asthma, Health education, Pregnancy
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2015
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Health education about asthma |
| No education | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education about asthmaThree 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? | Behavioural | Education |
Primary outcome
The level of asthma control
Time frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Assessment by the Asthma Control Questionnaire
3 secondary outcomes
Number of unscheduled visits to the doctor for asthma
Time frame: 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
Knowledge about asthma
Time frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Ninane, MD PhD principal investigator
CHU St Pierre Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education about asthma in people with Asthma, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of asthma control (time frame: Inclusion (baseline), 36 weeks of gestation, 12 weeks post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.