The PRIDE-Asthma cohort: insight into the short- and long-term effects of asthma and asthma medication during pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105751
• EU PAS number:
  EUPAS105750
• Study ID:
  105751
• Official title and acronym:
  The PRIDE-Asthma cohort: insight into the short- and long-term effects of asthma and asthma medication during pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  Norway
• Study description:
  Approximately 8% of pregnant women have asthma, making it one of the most common chronic conditions during pregnancy. 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. Multiple studies using large population-based databases, however, have shown that dispensing rates for asthma medication decline during pregnancy, suggestive of non-adherence and/or discontinuation of asthma medication. The objectives of this study are threefold: 1) To develop and validate a questionnaire to assess adherence to asthma medication use during pregnancy. 2) To assess reasons for self-initiated discontinuation of asthma medication and changes in asthma medication use during pregnancy. This includes assessment of trajectories of asthma control throughout pregnancy and identification of factors that are associated with improvements and deteriorations. 3) To initiate a focus cohort of at least 250 pregnant women with asthma to support this project and future studies on the short- and long-term safety of asthma medication during pregnancy. A multinational, cross-sectional study will be conducted for objective 1. The focus cohort for objectives 2 and 3 will be embedded in the PRIDE Study, an ongoing prospective cohort study among pregnant women and their offspring, with follow-up throughout childhood. Pregnant women with asthma will be asked to complete four Web-based asthma-specific questionnaires (at enrollment in the focus cohort, at gestational weeks 23 and 35, and 2 months post-partum), the Asthma Control Test (every four weeks throughout pregnancy and two times post-partum), and a medication diary (throughout pregnancy and 2 months post-partum). In addition, consent is asked to obtain data on medical history (GP and pulmonologist) and medication use (pharmacy).
• Study status:
  Planned

Research institution and networks

Institutions

Radboud University Medical Center (Radboudumc)

Netherlands

Pharmacoepidemiology and Drug Safety Research Group (PharmaSafe), University of Oslo

Norway

Study timelines

Date when funding contract was signed

Planned: 01/01/2020

Actual: 01/11/2021

Study start date

Planned: 01/09/2023

Date of final study report

Planned: 01/07/2026

Sources of funding

Non for-profit organisation (e.g. charity)

More details on funding

Stichting Astmabestrijding

Study protocol

Initial protocol

PRIDE-Astma_protocol_version1.2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable