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
Conditions: Intrauterine Devices
Sponsor: Bayer

 
Document 
Type: 
Study Protocol  
Official Title: 
Study on the Association of Uterine Perforation and 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) 
NCT Number: 
NCT03754556 
Document Date: 
29 Jun 2018 
 

Reference Number: RD-OI-0214 
Supplement Version: 5 
Observational/Post Authorization Study Information 
Title 
Protocol version identifier 
Date of last version of protocol 
IMP ACT study number 
Study type/Study phase 
Active substance 
Medicinal product 
Marketing authorization 
holder(s) 
Research question and 
objectives 
Study on the Association of Uterine £erforation and IUD 
Expulsion With Breastfeeding Status at the Time ofIUD 
Inse1tion and Postpaiium Timing of IUD Inse1tion in 
Electronic Medical Record Databases - A Postmai·keting 
Requirement for Mirena (APEX IUD) 
Version 2.0 (protocol amendment) 
29 June 2018 
19682 
□non-PASS
cgiPASS
Joint PASS: □YES 
□NO
Phase IV
Intrauterine contraceptives: Plastic IUD with 
progestogen (ATC code G02BA03) and Plastic IUD 
with copper (ATC code G02BA02) 
Mirena®, Skyla®, Liletta®, Kyleena®, and ParaGai·d® 
intrauterine devices 
Bayer AG, 13342 Berlin 
United States postmai·keting requirement study assessing 
outcomes of uterine perforation and intrauterine device 
(IUD) expulsion in association with breastfeeding, 
postpaitum exposures, and type of IUD. 
The study aims to quantify the risk of uterine perforation 
and IUD expulsion for the following compai·isons: 
•
Women who ai·e breastfeeding at the time of IUD
inse1tion versus not breastfeeding at the time of IUD
inse1tion
•
Women who had a first observed IUD inse1tion
within different time periods postpaiium
(i.e.,o 6 weeks, > 6 weeks ando 14 weeks,
> 14 weeks ando 52 weeks) versus women who had
their first observed IUD inse1tion more than
52 weeks postpartum, including women without a
recorded delive1y within the past 52 weeks
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