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Asthma Medication During PregnancyMAMP-AsthmeNCT06476041

Adherence to Asthma Medication During Pregnancy

An observational study of Asthma Medication During Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the last decades, the prevalence of asthma increased substantially and is still increasing in many countries. Approximately 8% of pregnant women have asthma, making it one of the most common chronic conditions during pregnancy. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Asthma Medication During Pregnancy
How many people
327 participants
Where
1 siteFrance
Study dates
15 Sep 2024to 14 Mar 2025
Phase
Observational
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women treated with asthma medication during pregnancy.

Who may be able to join

  • Aged between 18 and 50 years
  • Currently pregnant or have given birth in the past year.
  • Currently pregnant and using asthma medication, or have used asthma medication during pregnancy (postpartum women), and/or have used asthma medication in the 12 months before becoming pregnant.

Who cannot join

  • Women under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Trousseau

    Paris, 75012

Other trials in France

About this study

Official title: Utilization of Asthma Medication During Pregnancy: an Multinational, Cross-sectional, Internet-based Study - French Contribution

In the last decades, the prevalence of asthma increased substantially and is still increasing in many countries. Approximately 8% of pregnant women have asthma, making it one of the most common chronic conditions during pregnancy. Systematic reviews showed that pregnant women with asthma have an increased risk of pregnancy complications and adverse birth outcomes. Hence international recommendations emphasize the importance of adequate pharmacological treatment, stating that poor asthma control is associated with higher risks for the unborn child compared with asthma medication use. Multiple studies using large population-based database, however, have shown that dispensing rates of asthma medication decline during pregnancy, suggestive of non-adherence and/or discontinuation of asthma medication. This may lead to poor levels of asthma control and exacerbations.

While prescription data is inadequate to capture real-life adherence to medication, there is also a lack of suitable self-completed scales to measure adherence to asthma medication among pregnant women. The information the investigators currently have on adherence to asthma medication in pregnancy is from studies that have used pregnancy non-specific instruments, which do not consider pregnancy-related factors that could influence adherence, including fear of the potential teratogenic risk of asthma medications of untreated asthma to the fetus, as well as fluctuations in the severity of asthma throughout pregnancy.

Read more

In this study, invstigators will develop and adherence scale dedicated to asthma medication during pregnancy and investigators will include pregnancy-specific predictors of adherence as well as the woman's beliefs and perceptions regarding such use.

The recruitment of the patients will be done in various countries from Europe. This protocol covers the French contribution to this international initiative

Read the detailed description

In the last decades, the prevalence of asthma increased substantially and is still increasing in many countries.1 Approximately 8% of pregnant women have asthma, making it one of the most common chronic conditions during pregnancy. Systematic reviews showed that pregnant women with asthma have an increased risk of pregnancy complications and adverse birth outcomes, including gestational diabetes, preeclampsia, preterm birth, and low birth weight.As particularly women with poor levels of asthma control are at increased risk of adverse outcomes, international recommendations emphasize the importance of adequate pharmacological treatment, stating that poor asthma control is associated with higher risks for the unborn child compared with asthma medication use.

Multiple studies using large population-based database, however, have shown that dispensing rates of asthma medication decline during pregnancy, suggestive of non-adherence and/or discontinuation of asthma medication. Indeed, in a small-scale study, almost 30% of Dutch pregnant women discontinued or reduced the use of long-acting bronchodilators and combination preparations of an inhaler corticosteroid and long-acting bronchodilator when becoming pregnant. This may lead to poor levels of asthma control and exacerbations. Although the reasons for non-adherence are generally unknown, lack of information, incorrect perception of risks of asthma medication during pregnancy, previous experiences, and fluctuations in severity of asthma are hypothesized to play a role. More detailed information on adherence among pregnant women with asthma is scarce, because methodological limitations (e.g., cross-sectional or retrospective designs, no intra-individual comparisons, lack of data on level of asthma control, use of non-validated measurement instruments, and small study populations) hamper the interpretation of previous studies. More insight into the reasons why pregnant women do not adhere to treatment recommendations may improve counseling by prenatal care providers, resulting in better adherence to asthma medication during pregnancy.

While prescription data is inadequate to capture real-life adherence to medication, there is also a lack of suitable self-completed scales to measure adherence to asthma medication among pregnant women. The information investigators currently have on adherence to asthma medication in pregnancy is from studies that have used pregnancy non-specific instruments,11,12 which do not consider pregnancy-related factors that could influence adherence, including fear of the potential teratogenic risk of asthma medications of untreated asthma to the fetus, as well as fluctuations in the severity of asthma throughout pregnancy.

In this study, investigators will develop and adherence scale dedicated to asthma medication during pregnancy and investigators will include pregnancy-specific predictors of adherence as well as the woman's beliefs and perceptions regarding such use.

The recruitment of the patients will be done in various countries from Europe. This protocol covers the French contribution to this international initiative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. develop a multilanguage scale for measuring adherence to asthma medication during pregnancy.

    The primary aim of this study is to develop a multilanguage scale for measuring adherence to asthma medication during pregnancy (Adherence to Asthma Medication in Pregnancy Scale; AAMPS).

    Measured: Through study time period, 6 months

  2. evaluate a multilanguage scale for measuring adherence to asthma medication during pregnancy.

    The primary aim of this study is to evaluate a multilanguage scale for measuring adherence to asthma medication during pregnancy (Adherence to Asthma Medication in Pregnancy Scale; AAMPS).

    Measured: Through study time period, 6 months

Secondary outcomes (1)
  1. estimate the prevalence of low asthma medication adherence, as well as associated maternal factors.

    The secondary aim is to estimate the prevalence of low asthma medication adherence, as well as associated maternal factors.

    This will be done through the following specific objectives:

    1. assessment of the psychometric properties of the AAMPS scale and identification of cut-off levels for low and high adherence to asthma medication during pregnancy;
    2. description of the extent to which women adhere to asthma medication in pregnancy;
    3. determination of the maternal factors associated with low adherence asthma medication during pregnancy.

    Measured: Through study time period, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start15 Sep 2024
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476041
Sponsor's protocol ID
APHP240102
Acronym
MAMP-Asthme
Status last verified
Mar 2025
First submitted
13 Jun 2024
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma Medication During Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 1 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: finished, as of the sponsor's last update on 1 Apr 2025. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

develop a multilanguage scale for measuring adherence to asthma medication during pregnancy. (time frame: Through study time period, 6 months). The study lists 2 primary outcomes in all. 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 1 Apr 2025.

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