NCT03670784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,922,877

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2.4 years

First QC Date

September 12, 2018

Last Update Submit

April 29, 2022

Conditions

Pregnancy, Ectopic

Keywords

Ectopic pregnancyElectronic medical recordsChart ReviewIntrauterine device (IUD)

Outcome Measures

Primary Outcomes (3)

  • Number of ectopic pregnancies

    Overall and during contraceptive use

    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.

    Retrospective analysis of data from 2009 to 2018

  • Number of ectopic pregnancies

    During contraceptive and non- contraceptive use

    Retrospective analysis of data from 2009 to 2019

Secondary Outcomes (9)

  • Risk factors for ectopic pregnancies

    Retrospective analysis of data from 2009 to 2018

  • Accuracy of electronic health data to identify diagnosis of ectopic pregnancy

    Retrospective analysis of data from 2009 to 2018

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

    Retrospective analysis of data from 2009 to 2018

  • Accuracy of electronic health data to identify contraceptive method over time

    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

  • +4 more secondary outcomes

Study Arms (2)

Women_KPNC

Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC).

Other: No intervention

Women_KPSC

Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC).

Other: No intervention

Interventions

No interventionOTHER

No intervention, epidemiological investigation

Women_KPNCWomen_KPSC

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Health-insured women of reproductive age from California (USA)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

San Francisco, California, 94115, United States

Location

Related Links

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

December 1, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04

Locations

US(1)