Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

Number of pregnancies reported in participants at one month post insertion of IUD

This is a pragmatic prospective observational clinical research study to test the
 effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency
 contraception (EC) and same-day start use that will enroll people receiving care at Planned
 Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it
 works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test
 effectiveness (how well it works in the real world) in a larger, heterogenous population in a
 usual care setting where participants select their method and are not randomly assigned to
 it. The study population will include people initiating an LNG 52 mg IUD and meet inclusion
 and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood
 Federation of America was the first major healthcare organization to change its practice to
 incorporate the changes we are studying here. As such, all study participants will receive
 the standard of care at the site they visit which is not the standard of care by most sexual
 and reproductive healthcare providers. The primary outcome is pregnancy status one month
 after LNG IUD placement by home urine pregnancy test or clinical record review. Participant
 follow up concludes one month after enrollment.
 
 The care that is being provided at the clinical sites, including insertion of the LNG IUD is
 standard per this practice group. The purpose of this study is to demonstrate reproducibility
 of earlier findings in a more heterogenous population. As such, IUD placement is not a study
 procedure but a component of clinical care. The study interventions only involve study
 participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or
 same day start. We provide the IND information as it applies even though this is not a FDA
 phased clinical trial.