Pregnancy, EctopicNCT03670784
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
An observational study of Pregnancy, Ectopic, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Pregnancy, Ectopic
- How many people
- 3,922,877 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Health-insured women of reproductive age from California (USA)
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Ectopic
- Being tested
- No intervention
- Keywords
- Ectopic pregnancy, Electronic medical records, Chart Review, Intrauterine device (IUD)
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, epidemiological investigation
| Study group | Role | What they receive |
|---|---|---|
| Women_KPNC | Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC). Receives: Other: No intervention | |
| Women_KPSC | Women of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ectopic pregnancies
Overall and during contraceptive use
Measured: 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.
Measured: Retrospective analysis of data from 2009 to 2018
Number of ectopic pregnancies
During contraceptive and non- contraceptive use
Measured: Retrospective analysis of data from 2009 to 2019
Secondary outcomes (9)
Risk factors for ectopic pregnancies
Investigated risk factors comprise various demographic and clinical factors, contraceptive use and reproductive factors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed surgically
Measured: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed medically
Measured: 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
Measured: Retrospective analysis of data from 2009 to 2019
Accuracy of the contraceptive algorithm
Trained abstractors will conduct chart reviews.
Measured: Retrospective analysis of data from 2009 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Dec 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, EctopicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,922,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670784
- Sponsor's protocol ID
- 20257
- Status last verified
- Apr 2022
- First submitted
- 12 Sep 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Trend of Ectopic Pregnancy 2009-2018 - A Population-based Study
- ClinicalTrials.gov ID
- NCT03670784
- Acronym / sponsor ID
- 20257
- Conditions
- Pregnancy, Ectopic
- Keywords
- Ectopic pregnancy, Electronic medical records, Chart Review, Intrauterine device (IUD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,922,877 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women_KPNC | – | Other: No interventionWomen of reproductive age who are enrolled in the US-health plan Kaiser Permanente Northern California (KPNC). |
| Women_KPSC | – | Other: No interventionWomen of reproductive age who are enrolled in the US-health plan Kaiser Permanente Southern California (KPSC). |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Health-insured women of reproductive age from California (USA)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention, epidemiological investigation | Other | Women_KPNC, Women_KPSC |
Primary outcome
Number of ectopic pregnancies
Time frame: Retrospective analysis of data from 2009 to 2018
Overall and during contraceptive use
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.
Number of ectopic pregnancies
Time frame: Retrospective analysis of data from 2009 to 2019
During contraceptive and non- contraceptive use
9 secondary outcomes
Risk factors for ectopic pregnancies
Time frame: Retrospective analysis of data from 2009 to 2018
Accuracy of electronic health data to identify diagnosis of ectopic pregnancy
Time 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
Time frame: Retrospective analysis of data from 2009 to 2018
Accuracy of electronic health data to identify contraceptive method over time
Time frame: Retrospective analysis of data from 2009 to 2018
Accuracy of electronic health data to identify induced abortions
Time frame: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed surgically
Time frame: Retrospective analysis of data from 2009 to 2018
Numbers of ectopic pregnancies managed medically
Time frame: Retrospective analysis of data from 2009 to 2018
Risk factors for ectopic pregnancies
Time frame: Retrospective analysis of data from 2009 to 2019
Accuracy of the contraceptive algorithm
Time frame: Retrospective analysis of data from 2009 to 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Ectopic, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ectopic pregnancies (time frame: Retrospective analysis of data from 2009 to 2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.