check_circleStudy Completed

Pregnancy, Ectopic

Bayer Identifier:

20257

ClinicalTrials.gov Identifier:

NCT03670784

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.

Key Participants Requirements

Sex

Female

Age

15 - 44 Years
  • - 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

Trial summary

Enrollment Goal
3922877
Trial Dates
December 2018 - April 2021
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kaiser PermanenteSan Francisco, 94115, United States

Primary Outcome

  • Number of ectopic pregnancies
    Overall and during contraceptive use
    date_rangeTime 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.
    date_rangeTime Frame:
    Retrospective analysis of data from 2009 to 2018
  • Number of ectopic pregnancies
    During contraceptive and non- contraceptive use
    date_rangeTime Frame:
    Retrospective analysis of data from 2009 to 2019

Secondary Outcome

  • Risk factors for ectopic pregnancies
    Investigated 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 pregnancy
    Assessment 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 pregnancy
    Assessment 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 time
    Assessment 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 abortions
    Assessment 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 surgically
    date_rangeTime Frame:
    Retrospective analysis of data from 2009 to 2018
  • Numbers of ectopic pregnancies managed medically
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective analysis of data from 2009 to 2019
  • Accuracy of the contraceptive algorithm
    Trained abstractors will conduct chart reviews.
    date_rangeTime Frame:
    Retrospective analysis of data from 2009 to 2019

Trial design

Incidence and trend of ectopic pregnancy 2009-2018 - A population-based study
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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