Pregnancy protection and pregnancies in women of reproductive age on ACE-Inhibitors (ACEi), Angiotensin Receptor Blockers (ARB), statins or anti-diabetic medications: an observational study in primary care.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106501
• EU PAS number:
  EUPAS106500
• Study ID:
  106501
• Official title and acronym:
  Pregnancy protection and pregnancies in women of reproductive age on ACE-Inhibitors (ACEi), Angiotensin Receptor Blockers (ARB), statins or anti-diabetic medications: an observational study in primary care.
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Background The number of people living with long-term conditions, such as high blood pressure, high cholesterol, and diabetes, is on the rise. This includes women of reproductive or childbearing age. Increasing numbers of women in this group are prescribed medicines by their GPs to treat these conditions. Some of these medicines, if taken during pregnancy, have the potential to harm an unborn baby. Our earlier published work focussed on medications for high blood pressure, called angiontensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs). We estimated that over half of women are not told about the risks of these medications and not told to use effective contraception. To our knowledge, this research has not been expanded to look at a wider range of other potentially harmful medicines, to understand how big this problem is. We plan to find out: How often are medications for high blood pressure, high cholesterol and diabetes are prescribed to women of childbearing age? How many of these women have a pregnancy? How often are this group prescribed effective contraception? Methods We will answer these questions by using the Clinical Practice Research Datalink (CPRD) which collects anonymised patient data from UK GP practices. This includes 60 million patient records. We will look the medical records of a sample of women aged 15-49 from this database to answer our questions. We will use our results to understand how large this problem is in UK primary care and try to find out whether current practice is putting women and their babies at potential risk. We will inform patient groups, GPs and appropriate regulatory bodies about our results, to ensure any improvements needed can be made long term. The knowledge gained will form essential preliminary work towards future research, to help women to make better decisions about their treatments and pregnancy plans and improve care and prescribing in this area.
• Study status:
  Planned

Research institutions and networks

Institutions

University of Southampton

Study timelines

Date when funding contract was signed

Actual: 01/03/2023

Study start date

Planned: 01/11/2023

Date of final study report

Planned: 01/07/2024

Sources of funding

Other

More details on funding

NIHR School for Primary Care Research

Regulatory

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