Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670784
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Pregnancy, Ectopic 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Trend of Ectopic Pregnancy 2009-2018 - A Population-based Study
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of ectopic pregnancies [ Time Frame: Retrospective analysis of data from 2009 to 2018 ]
  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.


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Health-insured women of reproductive age from California (USA)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670784


Locations
Layout table for location information
United States, California
Kaiser Permanente
San Francisco, California, United States, 94115
Sponsors and Collaborators
Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03670784     History of Changes
Other Study ID Numbers: 20257
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ectopic pregnancy
Electronic medical records
Chart Review
Intrauterine device (IUD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy, Ectopic
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Pregnancy Complications