Clinical trial NCT06476041: Adherence to Asthma Medication During Pregnancy
Official title: Utilization of Asthma Medication During Pregnancy: an Multinational, Cross-sectional, Internet-based Study - French Contribution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Medication During Pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-06-26
Enrollment: 327
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women treated with asthma medication during pregnancy.

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Women under legal protection

Primary outcomes:
measure: develop a multilanguage scale for measuring adherence to asthma medication during pregnancy.
timeFrame: Through study time period, 6 months
measure: evaluate a multilanguage scale for measuring adherence to asthma medication during pregnancy.
timeFrame: Through study time period, 6 months
Secondary outcomes:
measure: estimate the prevalence of low asthma medication adherence, as well as associated maternal factors.
timeFrame: Through study time period, 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Trousseau
Study officials:
References: