check_circleStudy Completed
Pregnancy, Ectopic
Bayer Identifier:
20257
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Occurrence and trend of pregnancies growing outside the womb (Ectopic Pregnancy) 2009-2018. A study on a defined group of persons
Trial purpose
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.
• 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.
Key Participants Requirements
Sex
FemaleAge
15 - 44 YearsTrial summary
Enrollment Goal
3922877Trial Dates
December 2018 - April 2021Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kaiser Permanente | San Francisco, 94115, United States |
Primary Outcome
- Number of ectopic pregnanciesOverall and during contraceptive usedate_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Person-time at riskPerson-time at risk is the time without ectopic pregnancy [in years, months, or days] that all subjects contributed to the study since enrollment.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Number of ectopic pregnanciesDuring contraceptive and non- contraceptive usedate_rangeTime Frame:Retrospective analysis of data from 2009 to 2019
Secondary Outcome
- Risk factors for ectopic pregnanciesInvestigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Accuracy of electronic health data to identify diagnosis of ectopic pregnancyAssessment by chart review of random samples of 0.001% of women per site and year.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Accuracy of electronic health data to identify contraceptive method at time of diagnosis of ectopic pregnancyAssessment by chart review of random samples of 0.001% of women per site and year.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Accuracy of electronic health data to identify contraceptive method over timeAssessment by chart review of random samples of 0.001% of women per site and year.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Accuracy of electronic health data to identify induced abortionsAssessment by chart review of random samples of 0.001% of women per site and year.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Numbers of ectopic pregnancies managed surgicallydate_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Numbers of ectopic pregnancies managed medicallydate_rangeTime Frame:Retrospective analysis of data from 2009 to 2018
- Risk factors for ectopic pregnanciesRisk factors will be investigated in women with current contraceptive use and non-contraceptivedate_rangeTime Frame:Retrospective analysis of data from 2009 to 2019
- Accuracy of the contraceptive algorithmTrained abstractors will conduct chart reviews.date_rangeTime Frame:Retrospective analysis of data from 2009 to 2019
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A