An observational study in Pregnancy, Ectopic, sponsored by Bayer. Completed at 1 site in United States. Open to female participants aged 15 Years to 44 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Bayer · Observational
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 3,922,877 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Health-insured women of reproductive age from California (USA)
Inclusion Criteria:
Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC).
Other: No intervention
Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC).
Other: No intervention
No intervention, epidemiological investigation
Number of ectopic pregnancies
Overall and during contraceptive use
Time frame: 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.
Time frame: Retrospective analysis of data from 2009 to 2018
Number of ectopic pregnancies
During contraceptive and non- contraceptive use
Time frame: Retrospective analysis of data from 2009 to 2019
Risk factors for ectopic pregnancies
Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed surgically
Time frame: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed medically
Time frame: 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
Time frame: Retrospective analysis of data from 2009 to 2019
Accuracy of the contraceptive algorithm
Trained abstractors will conduct chart reviews.
Time frame: Retrospective analysis of data from 2009 to 2019
Plan to share: Undecided — 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.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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