Relationship of parity and prior cesarean delivery to levonorgestrel 52 mg intrauterine system expulsion over 6 years

Melissa L Gilliam; Jeffrey T Jensen; David L Eisenberg; Michael A Thomas; Andrea Olariu; Mitchell D Creinin

doi:10.1016/j.contraception.2021.02.013

Relationship of parity and prior cesarean delivery to levonorgestrel 52 mg intrauterine system expulsion over 6 years

Contraception. 2021 Jun;103(6):444-449. doi: 10.1016/j.contraception.2021.02.013. Epub 2021 Feb 28.

Authors

Melissa L Gilliam¹, Jeffrey T Jensen², David L Eisenberg³, Michael A Thomas⁴, Andrea Olariu⁵, Mitchell D Creinin⁶

Affiliations

¹ Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.
² Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR, United States.
³ Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, United States.
⁴ Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, United States.
⁵ Medicines360, San Francisco, CA, United States.
⁶ Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mdcreinin@ucdavis.edu.

PMID: 33651995
DOI: 10.1016/j.contraception.2021.02.013

Abstract

Objective: Assess the relationship between parity and prior route of delivery to levonorgestrel 52 mg intrauterine system (IUS) expulsion during the first 72 months of use.

Study design: We evaluated women enrolled in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta levonorgestrel 52 mg IUS. Investigators evaluated IUS presence at 3 and 6 months after placement and then every 6 months and during unscheduled visits. We included women with successful placement and at least one follow-up assessment. We evaluated expulsion rates based on obstetric history; for prior delivery method subanalyses, we excluded 12 participants with missing delivery data. We determined predictors of expulsion using multivariable regression analyses.

Results: Of 1714 women with IUS placement, 1710 had at least one follow-up assessment. The total population included 986 (57.7%) nulliparous women. Sixty-five (3.8%) women experienced expulsion within 72 months, 50 (76.9%) within the first 12 months. Expulsion rates among nulliparous women (22/986 [2.2%]) or parous women with any pregnancy ending with a Cesarean delivery (6/195 [3.1%]) differed from parous women who only experienced vaginal deliveries (37/517 [7.2%]) (p < 0.001). In multivariable regression, obesity (adjusted odds ratio [aOR] 2.2, 95% confidence interval [CI] 1.3-3.7), parity (aOR 2.2, 95% CI 1.2-4.1), and non-white race (aOR 1.8, 95% CI 1.1-3.2) predicted expulsion. Among parous women, obesity (aOR 2.2, 95% CI 1.2-4.2) increased the odds and having ever had a cesarean delivery (aOR 0.4, 95% CI 0.1-0.9) decreased the odds of expulsion.

Conclusion: IUS expulsion occurs in less than 4% of users over the first 6 years of use and occurs mostly during the first year. Expulsion is more likely among obese and parous women.

Implications: Levonorgestrel 52 mg intrauterine system expulsion occured more commonly in parous than nulliparous women; the increase in parous women is primarily in women who had vaginal deliveries only. The association between obesity, delivery route, and IUS expulsion needs further elucidation.

Keywords: Expulsion; Intrauterine device; Intrauterine system; Liletta; Obesity.

Publication types

Clinical Trial, Phase III
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Cesarean Section
Contraceptive Agents, Female*
Female
Humans
Intrauterine Devices, Medicated*
Levonorgestrel
Parity
Pregnancy

Substances

Contraceptive Agents, Female
Levonorgestrel