Adherence to Asthma Medication During Pregnancy
NCT Number: NCT06476041
Acronym: MAMP-Asthme
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Asthma Medication During Pregnancy
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: University of Oslo
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-31

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. 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

Primary Outcome Measures: 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)., 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)., Through study time period, 6 months
Secondary Outcome Measures: 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., Through study time period, 6 months