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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 ...
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women_KPNC | Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC). |
| |
| Women_KPSC | Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention, epidemiological investigation |
|
| 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 |
| 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 |
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Inclusion Criteria:
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Health-insured women of reproductive age from California (USA)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | San Francisco | California | 94115 | United States |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |