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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Ectopic
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 3922877

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women_KPNC; Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC).	Other: No intervention; No intervention, epidemiological investigation
Women_KPSC; Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC).	Other: No intervention; No intervention, epidemiological investigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for ectopic pregnancies	Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors.	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.	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.	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.	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.	Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed surgically		Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed medically		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	Retrospective analysis of data from 2009 to 2019
Accuracy of the contraceptive algorithm	Trained abstractors will conduct chart reviews.	Retrospective analysis of data from 2009 to 2019

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Ectopic pregnancy; Intrauterine device (IUD); Chart Review; Electronic medical records
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: 20257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No