Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence and Trend of Ectopic Pregnancy 2009-2018 - A Population-based Study

Conditions
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Pregnancy, Ectopic

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women_KPNC<br>Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC). | Other: No intervention<br>* No intervention, epidemiological investigation<br>|
| Women_KPSC<br>Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC). | Other: No intervention<br>* No intervention, epidemiological investigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ectopic pregnancies | Overall and during contraceptive use | Retrospective analysis of data from 2009 to 2018 | 
| Person-time at risk | Person-time at risk is the time without ectopic pregnancy [in years, months, or days] that all subjects contributed to the study since enrollment. | Retrospective analysis of data from 2009 to 2018 | 
| Number of ectopic pregnancies | During contraceptive and non- contraceptive use | Retrospective analysis of data from 2009 to 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for ectopic pregnancies | Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors. | Retrospective analysis of data from 2009 to 2018 | 
| Accuracy of electronic health data to identify diagnosis of ectopic pregnancy | Assessment by chart review of random samples of 0.001% of women per site and year. | Retrospective analysis of data from 2009 to 2018 | 
| Accuracy of electronic health data to identify contraceptive method at time of diagnosis of ectopic pregnancy | Assessment by chart review of random samples of 0.001% of women per site and year. | Retrospective analysis of data from 2009 to 2018 | 
| Accuracy of electronic health data to identify contraceptive method over time | Assessment by chart review of random samples of 0.001% of women per site and year. | Retrospective analysis of data from 2009 to 2018 | 
| Accuracy of electronic health data to identify induced abortions | Assessment by chart review of random samples of 0.001% of women per site and year. | Retrospective analysis of data from 2009 to 2018 | 
| Numbers of ectopic pregnancies managed surgically |  | Retrospective analysis of data from 2009 to 2018 | 
| Numbers of ectopic pregnancies managed medically |  | Retrospective analysis of data from 2009 to 2018 | 
| Risk factors for ectopic pregnancies | Risk factors will be investigated in women with current contraceptive use and non-contraceptive | Retrospective analysis of data from 2009 to 2019 | 
| Accuracy of the contraceptive algorithm | Trained abstractors will conduct chart reviews. | Retrospective analysis of data from 2009 to 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ectopic pregnancy, Electronic medical records, Chart Review, Intrauterine device (IUD)