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

Pregnancy, Ectopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670784
• Other study ID #: 20257
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3922877
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Ectopic

Intervention

Other:
• No intervention
No intervention, epidemiological investigation

Locations

Country	Name	City	State
United States	Kaiser Permanente	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ectopic pregnancies	Overall and during contraceptive use	Retrospective analysis of data from 2009 to 2018
Primary	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
Primary	Number of ectopic pregnancies	During contraceptive and non- contraceptive use	Retrospective analysis of data from 2009 to 2019
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Numbers of ectopic pregnancies managed surgically		Retrospective analysis of data from 2009 to 2018
Secondary	Numbers of ectopic pregnancies managed medically		Retrospective analysis of data from 2009 to 2018
Secondary	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
Secondary	Accuracy of the contraceptive algorithm	Trained abstractors will conduct chart reviews.	Retrospective analysis of data from 2009 to 2019

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