Clinical trial NCT03670784: Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
Official title: Incidence and Trend of Ectopic Pregnancy 2009-2018 - A Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Ectopic
Keywords: Ectopic pregnancy
Electronic medical records
Chart Review
Intrauterine device (IUD)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 3922877
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health-insured women of reproductive age from California (USA)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of ectopic pregnancies
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Person-time at risk
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Number of ectopic pregnancies
timeFrame: Retrospective analysis of data from 2009 to 2019
Secondary outcomes:
measure: Risk factors for ectopic pregnancies
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Accuracy of electronic health data to identify diagnosis of ectopic pregnancy
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Accuracy of electronic health data to identify contraceptive method at time of diagnosis of ectopic pregnancy
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Accuracy of electronic health data to identify contraceptive method over time
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Accuracy of electronic health data to identify induced abortions
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Numbers of ectopic pregnancies managed surgically
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Numbers of ectopic pregnancies managed medically
timeFrame: Retrospective analysis of data from 2009 to 2018
measure: Risk factors for ectopic pregnancies
timeFrame: Retrospective analysis of data from 2009 to 2019
measure: Accuracy of the contraceptive algorithm
timeFrame: Retrospective analysis of data from 2009 to 2019
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
Study officials:
References: