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.
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.
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
- Conditions
- Asthma Medication During Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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:
- 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;
- description of the extent to which women adhere to asthma medication in pregnancy;
- 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.
- First posted26 Jun 2024
- Study start15 Sep 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma Medication During PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Asthma Medication During Pregnancy: an Multinational, Cross-sectional, Internet-based Study - French Contribution
- ClinicalTrials.gov ID
- NCT06476041
- Acronym / sponsor ID
- MAMP-Asthme / APHP240102
- Conditions
- Asthma Medication During Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- 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.
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.
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
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women treated with asthma medication during pregnancy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Women under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
develop a multilanguage scale for measuring adherence to asthma medication during pregnancy.
Time frame: Through study time period, 6 months
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).
evaluate a multilanguage scale for measuring adherence to asthma medication during pregnancy.
Time frame: Through study time period, 6 months
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).
1 secondary outcome
estimate the prevalence of low asthma medication adherence, as well as associated maternal factors.
Time frame: Through study time period, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.