Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Adherence to Asthma Medication During Pregnancy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Utilization of Asthma Medication During Pregnancy an Multinational Cross-sectional Internet-based Study - French Contribution
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAMP-Asthme
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 andor 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 womans 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
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 womans 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 countries1 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 weightAs 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 andor 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 eg 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 instruments1112 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 womans 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
Multiple studies using large population-based database however have shown that dispensing rates of asthma medication decline during pregnancy suggestive of non-adherence andor 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 eg 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 instruments1112 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 womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None