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

Completed

• Conditions: Pregnancy, Ectopic
• Interventions: Other: No intervention

• Registration Number: NCT03670784
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-12-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3922877

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women_KPNC	No intervention	Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC).
Women_KPSC	No intervention	Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 San Francisco, California, United States