Incidence and Trend of Ectopic Pregnancy 2009-2018 - A population-based Study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Accuracy of electronic health data
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Ectopic pregnancy

Population studied

• Short description of the study population:
  The study will take place within health care systems with EHR data in California.; The study population will include women enrolled in the health plans of the two systems who were age 15 to 44 years from January 1, 2009 to December 31, 2018.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  2000000

Study design details

• Main study objective:
  The overall goal of this study is to assess the incidence rate of ectopic pregnancy over the last decade in a representative population of US women and potential risk factors associated with ectopic pregnancy.
• Outcomes:
  Number of ectopic pregnancies / Person-time at risk, Risk factors for ectopic pregnancies / Accuracy of electronic health data to identify a) the diagnosis of ectopic pregnancy, b) the contraceptive method at time of diagnosis of ectopic pregnancy, c) the contraceptive method over time and d) induced abortions / Numbers of ectopic pregnancies managed surgically / Numbers of ectopic pregnancies managed medically
• Data analysis plan:
  Descriptive analyses for all variables of interest will be presented overall and within each database for the study cohort. For categorical variables, frequencies and percentages will be presented for each level. Continuous variables will be summarized by the mean, standard deviation, minimum, maximum, median, and quartiles. For estimates, two-sided 95% confidence intervals will be calculated. The proportion of missing data will be captured for each variable. Demographic and clinical characteristics of patients experiencing the following outcomes will be presented: Ectopic pregnancies, Surgically treated, Medically treated, and Unknown/other (includes expectant management) Characteristics will include frequencies and percentages for each level of each outcome and by demographics and clinical characteristics of patients at the index date.

Documents

Study results

20257_EU_PAS_Abstract_Redacted_V1.0_2022-02-23