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Completed

NCT Number: NCT03670784

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

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.

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Key information

Conditions

Pregnancy, Ectopic Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

15 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Kaiser Permanente

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention, epidemiological investigation

Primary outcomes

  1. Number of ectopic pregnancies

    Time frame: Retrospective analysis of data from 2009 to 2018

    Overall and during contraceptive use

  2. Person-time at risk

    Time frame: 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.

  3. Number of ectopic pregnancies

    Time frame: Retrospective analysis of data from 2009 to 2019

    During contraceptive and non- contraceptive use

Secondary outcomes

  1. Risk factors for ectopic pregnancies

    Time frame: Retrospective analysis of data from 2009 to 2018

    Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors.

  2. Accuracy of electronic health data to identify diagnosis of ectopic pregnancy

    Time frame: Retrospective analysis of data from 2009 to 2018

    Assessment by chart review of random samples of 0.001% of women per site and year.

  3. Accuracy of electronic health data to identify contraceptive method at time of diagnosis of ectopic pregnancy

    Time frame: Retrospective analysis of data from 2009 to 2018

    Assessment by chart review of random samples of 0.001% of women per site and year.

  4. Accuracy of electronic health data to identify contraceptive method over time

    Time frame: Retrospective analysis of data from 2009 to 2018

    Assessment by chart review of random samples of 0.001% of women per site and year.

  5. Accuracy of electronic health data to identify induced abortions

    Time frame: Retrospective analysis of data from 2009 to 2018

    Assessment by chart review of random samples of 0.001% of women per site and year.

  6. Numbers of ectopic pregnancies managed surgically

    Time frame: Retrospective analysis of data from 2009 to 2018

  7. Numbers of ectopic pregnancies managed medically

    Time frame: Retrospective analysis of data from 2009 to 2018

  8. Risk factors for ectopic pregnancies

    Time frame: Retrospective analysis of data from 2009 to 2019

    Risk factors will be investigated in women with current contraceptive use and non-contraceptive

  9. Accuracy of the contraceptive algorithm

    Time frame: Retrospective analysis of data from 2009 to 2019

    Trained abstractors will conduct chart reviews.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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