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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C10AA01) simvastatin

  simvastatin

  (A10BK01) dapagliflozin

  dapagliflozin

  (C09AA05) ramipril

  ramipril

  (C09CA06) candesartan

  candesartan
• Medical condition to be studied:
  Pregnancy

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  12500

Study design details

• Main study objective:
  The overall objective is to ascertain how many women of reproductive age (15-55 years) are prescribed potentially teratogenic, but commonly prescribed, medications including ACEi and ARBs, anti-diabetic medications (excluding metformin and insulin) and statins. Then to evaluate what proportion of these women are prescribed contraception or have a pregnancy.
• Outcomes:
  1. Proportion of patients with the exposure who had a coded prescription for contraception up to 10 years prior to initiation of the medication of interest 2. Proportion of patients with the exposure who had a pregnancy coded in the pregnancy registry whilst in receipt of an active prescription of a medication of interest
• Data analysis plan:
  Patient characteristics, rates of prescription for medications of interest, proportion of patients receiving a contraception prescription and/or conceiving a pregnancy will be summarised using descriptive statistics, using counts/percentages or means/medians as appropriate for categorical and continuous variables, respectively. Data will be reported as per STROBE and RECORD guidelines for observational studies using routinely collected health data, analysed using STATA and described graphically where appropriate.