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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46964
• 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

Kaiser Permanente Northern California Oakland, USA, Kaiser Permanente Southern California Pasadena, USA

Study timelines

Date when funding contract was signed

Planned: 30/06/2018

Actual: 27/06/2018

Study start date

Planned: 01/12/2018

Actual: 01/12/2018

Date of final study report

Planned: 15/11/2021

Actual: 15/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

Study 20257_Study Protocol_Amendment_Redacted_V2_10_28_2020

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CT.gov: NCT03670784,Bayer number: 20257