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 institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Kaiser Permanente Northern California Oakland, USA, Kaiser Permanente Southern California Pasadena, USA, Kaiser Permanente Washington Seattle, USA, Regenstrief Institute Indianapolis, USA

Contact details

Bayer Clinical Trials Bayer AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
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

English (708.64 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only