Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial

David Hubacher; Courtney A Schreiber; David K Turok; Jeffrey T Jensen; Mitchell D Creinin; Kavita Nanda; Katharine O'Connell White; Ila Dayananda; Stephanie B Teal; Pai-Lien Chen; Beatrice A Chen; Alisa B Goldberg; Jennifer L Kerns; Clint Dart; Anita L Nelson; Michael A Thomas; David F Archer; Jill E Brown; Paula M Castaño; Anne E Burke; Bliss Kaneshiro; Diana L Blithe

doi:10.1016/j.eclinm.2022.101554

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial

EClinicalMedicine. 2022 Jul 16:51:101554. doi: 10.1016/j.eclinm.2022.101554. eCollection 2022 Sep.

Authors

David Hubacher¹, Courtney A Schreiber², David K Turok³, Jeffrey T Jensen⁴, Mitchell D Creinin⁵, Kavita Nanda¹, Katharine O'Connell White⁶, Ila Dayananda⁷, Stephanie B Teal⁸, Pai-Lien Chen¹, Beatrice A Chen⁹, Alisa B Goldberg¹⁰, Jennifer L Kerns¹¹, Clint Dart¹², Anita L Nelson¹³, Michael A Thomas¹⁴, David F Archer¹⁵, Jill E Brown¹⁶, Paula M Castaño¹⁷, Anne E Burke¹⁸, Bliss Kaneshiro¹⁹, Diana L Blithe¹⁶

Affiliations

¹ FHI 360, Durham, NC, USA.
² Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
³ Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA.
⁴ Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR, USA.
⁵ Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.
⁶ Department of Obstetrics and Gynecology, Boston University, Boston, MA, USA.
⁷ Planned Parenthood Greater New York, New York, NY, USA.
⁸ Department of Obstetrics and Gynecology, University Hospitals Medical Center and Case Western Reserve University, Cleveland, OH, USA.
⁹ Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, PA, USA.
¹⁰ Planned Parenthood League of Massachusetts, Boston, MA, USA.
¹¹ Department of Obstetrics, Gynecology and Reproductive Sciences, Center for Global Reproductive Health, University of California, San Francisco, San Francisco, CA, USA.
¹² Health Decisions, Durham, NC, USA.
¹³ Essential Access Health, Los Angeles, CA, USA.
¹⁴ Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, USA.
¹⁵ Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA.
¹⁶ Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
¹⁷ Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, NY, USA.
¹⁸ Department of Gynecology and Obstetrics, Johns Hopkins University, Baltimore, MD, USA.
¹⁹ Department of Obstetrics, Gynecology, and Women's Health, University of Hawaii, Honolulu, HI, USA.

Abstract

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users.

Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment.

Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively.

Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy.

Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

Keywords: 12-Month; Bleeding and pain; Blinded; Comparative; Continuation rates; Copper intrauterine device; Early removal; Expulsion; IUD; Nulliparous; Randomized; Satisfaction; Trial.

Associated data

ClinicalTrials.gov/NCT03124160