Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena (APEX IUD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Mirena
• Anatomical Therapeutic Chemical (ATC) code:
  (G02BA03) plastic IUD with progestogen
• Medical condition to be studied:
  Uterine perforation

  Device expulsion

Population studied

• Short description of the study population:
  The study population will be women with evidence of insertion of an IUD during the study period who were no more than 50 years of age at the time of the insertion. Only women with available EHR records from 12 months before the day of IUD insertion and onward will be included in this study.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  225000

Study design details

• Main study objective:
  1. To compare the risk of uterine perforation among women who were breastfeeding versus women who were not breastfeeding at the time of first IUD insertion2. To evaluate the risk of uterine perforation among women who had their first IUD insertion within different time periods postpartum, including women without a recorded delivery
• Outcomes:
  Person-time at risk / Confirmed date of uterine perforation / Confirmed date of IUD-expulsion, Incidence rate & Cumulative incidence rate of uterine perforation or IUD expulsion / Incidence of difficult IUD-insertion / Adjusted hazard ratio of uterine perforation or IUD-expulsion / Adjusted incidence rate ratio (IRR) & Adjusted incidence rate difference (IRD) of uterine perforation or IUD expulsion / Effect modification for uterine perforation or IUD expulsion
• Data analysis plan:
  Descriptive analyses for all variables of interest will be presented overall and stratified by database. For categorical variables, frequencies and percentages will be presented for each level. For continuous variables, the mean, standard deviation, minimum, maximum, median, and quartiles will be presented. For estimates, two-sided 95% confidence intervals will be calculated.Crude incidence rates and cumulative incidence of the outcomes will be estimated for each exposure group.Crude hazard ratios will be calculated for each outcome without adjustment for covariates within each database. Confounding adjustment will be performed via overlap weighting. Adjusted hazard ratios will be calculated accounting for the propensity score–based weighting approach.Effect estimates across datasources will be estimated. Analyses of the adjusted hazard ratios for the two primary objectives combined will include hypothesis testing using two-sided statistical test.

Documents

Study results

19682_CSR abstract_v1.0_2020-11-11