Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena (APEX IUD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38003
• EU PAS number:
  EUPAS33461
• Study ID:
  38003
• Official title and acronym:
  Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena (APEX IUD)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is an US postmarketing requirement that investigates the outcomes of uterine perforation and intrauterine device (IUD) expulsion in association with breastfeeding, postpartum exposures and type of IUD.The study aims to quantify the risk of uterine perforation and IUD expulsion in relation to the breastfeeding status and postpartum time (≤ 6, > 6 ≤ 14, > 14, ≤ 52 or > 52 weeks postpartum, including women without a recorded delivery within the past 52 weeks) at the time of IUD insertionThis study will also assess the risk of both perforation and expulsion by type of IUD. The effect of IUD types (LNG-releasing vs. copper) on the association between perforation/ expulsion and breastfeeding status/ postpartum status, as well as the effect of breastfeeding status on the association between perforation and/or expulsion and postpartum status are also investigated.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Kaiser Permanente Northern California Oakland, USA, Kaiser Permanente Southern California Pasadena, USA, Kaiser Permanente Washington Seattle, USA, Regenstrief Institute Indianapolis, USA

Study timelines

Date when funding contract was signed

Planned: 29/06/2016

Actual: 29/06/2016

Study start date

Planned: 01/12/2018

Actual: 03/12/2018

Date of final study report

Planned: 30/04/2020

Actual: 03/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

19682_Study Protocol_v1.0_2019-06-29_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CT.gov: NCT03754556Bayer No.: 19682