Pregnancy, Ectopic
Conditions
Keywords
Ectopic pregnancy, Electronic medical records, Chart Review, Intrauterine device (IUD)
Brief summary
In this trial researchers want to learn more about the occurrence of pregnancies growing outside the womb over the last decade (2009-2018) and the potential risk factors associated with pregnancies growing outside the womb. Electronic data in women who were age 15 to 44 years abstracted from health care systems such as electronic health records (EHR), regional claims systems and administrative databases were used to address research questions on ... * occurrence and trends of pregnancies growing outside the womb; * influence of method of contraception used on occurrence and trends of pregnancies growing outside the womb; * potential risk factors associated with pregnancies growing outside the womb; * trends in management of pregnancies growing outside the womb over the last decade.
Detailed description
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.
Interventions
OTHERNo intervention
No intervention, epidemiological investigation
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Women of age 15 to 44 years between 01-Jan-2009 and 31-Dec-2018 * Women enrolled in health plans Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Southern California (KPSC) * Women with at least 12 months membership in KPNC and KPSC prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ectopic pregnancies | Retrospective analysis of data from 2009 to 2018 | Overall and during contraceptive use |
| Person-time at risk | Retrospective analysis of data from 2009 to 2018 | Person-time at risk is the time without ectopic pregnancy \[in years, months, or days\] that all subjects contributed to the study since enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of electronic health data to identify contraceptive method at time of diagnosis of ectopic pregnancy | Retrospective analysis of data from 2009 to 2018 | Assessment by chart review of random samples of 0.001% of women per site and year. |
| Accuracy of electronic health data to identify contraceptive method over time | Retrospective analysis of data from 2009 to 2018 | Assessment by chart review of random samples of 0.001% of women per site and year. |
| Accuracy of electronic health data to identify induced abortions | Retrospective analysis of data from 2009 to 2018 | Assessment by chart review of random samples of 0.001% of women per site and year. |
| Risk factors for ectopic pregnancies | Retrospective analysis of data from 2009 to 2018 | Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors. |
| Numbers of ectopic pregnancies managed medically | Retrospective analysis of data from 2009 to 2018 | — |
| Accuracy of the contraceptive algorithm | Retrospective analysis of data from 2009 to 2019 | Trained abstractors will conduct chart reviews. |
| Numbers of ectopic pregnancies managed surgically | Retrospective analysis of data from 2009 to 2018 | — |
| Accuracy of electronic health data to identify diagnosis of ectopic pregnancy | Retrospective analysis of data from 2009 to 2018 | Assessment by chart review of random samples of 0.001% of women per site and year. |
Countries
United States
Outcome results
None listed