Study identification

EU PAS number

EUPAS33562

Study ID

46964

Official title and acronym

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

DARWIN EU® study

No

Study countries

United States

Study description

The overall goal of this retrospective cohort study is to assess the incidence rate of ectopic pregnancy over the last decade in a representative population of US women and assess potential risk factors associated with ectopic pregnancy. The research will utilize Kaiser Permanente electronic health records to assess whether ectopic pregnancy incidence rates have changed over the last decade overall as well as in women using prescription contraceptive methods of interest including in IUDs, OCPs and DMPA. The objectives of the study are: - To describe the incidence and temporal trends of ectopic pregnancy during the past decade in women of reproductive age and in subpopulations with selected prescriptive contraceptive use, in particular hormonal and non-hormonal IUDs. - To describe demographic and clinical risk factors associated with ectopic pregnancy and to determine the accuracy of data from electronic health records for assessing prescribed contraceptive method over time.

Study status

Finalised
Research institutions and networks

Institutions

Bayer AG
First published:
01/02/2024
Institution
Kaiser Permanente Northern California Oakland, USA, Kaiser Permanente Southern California Pasadena, USA

Contact details

Bayer Clinical Trials Bayer AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable