Abstract
Objectives
To compare pain and ease of insertion of the copper 380 mm2, levonorgestrel 52 mg, and levonorgestrel 19.5-mg intrauterine devices (IUDs) in
Brazilian adolescents.
Study design
We conducted a participant-blinded randomized trial at two clinics in Brazil. We enrolled
318 adolescents<19 years old in a 1:1:1 ratio from November 2021 to February 2022.
We informed the adolescents about the IUD type inserted after they evaluated the pain
associated with the IUD insertion using a Visual Analogue Scale and immediately after
that the healthcare provider who placed the IUD evaluated the ease of the procedure.
Results
The VAS pain level was significantly higher after the levonorgestrel 52-mg IUD placement, median
and [interquartile range, IQ] 8.0 [4.0] than the copper 380-mm2 IUD 7.0 [4.0], and the levonorgestrel 19.5-mg IUD 7.0 [6.0] (p = 0.001). The placement was easier after the copper 380-mm2 IUD (87/106, 82.1%) and the levonorgestrel 19.5-mg IUD (91/106, 85.8%) when compared
with the levonorgestrel 52-mg IUD (75/105, 70.7%). After multiple logistic regression
analyses, the higher VAS pain scores were associated with the levonorgestrel 52-mg
IUD (OR = 2.90), low number of pregnancies (OR –0.48), and with a history of dysmenorrhea
(OR = 2.67).
Conclusions
The placement of the copper 380-mm2 IUD and the levonorgestrel 19.5-mg IUD was associated with lower pain according to
the adolescent and was easier according to the provider when compared with the levonorgestrel
52-mg IUD. However, the small observed differences may not be clinically relevant.
Implications
We found that the three types of IUDs were generally easy to place; however, mean
pain scores were high during insertions. Our findings of high pain scores reinforce
the need for interventions to reduce pain for adolescent IUD insertion.
Keywords
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Article info
Publication history
Published online: February 23, 2023
Accepted:
February 16,
2023
Received in revised form:
February 7,
2023
Received:
December 12,
2022
Publication stage
In Press Corrected ProofFootnotes
☆Declaration of Competing Interest: LB received honorarium to be a member of the advisory board and has been an invited speaker at scientific meetings for Bayer Healthcare Pharmaceuticals, Merck, Organon, and Vifor. The other authors declare no conflicts of interest.
☆☆Funding: This study received partial financial support from the São Paulo Research Council (FAPESP) award 2015/10021 and from the Brazilian National Research Council (CNPq), grant #573747/2008-3. The 52-mg hormonal IUDs used in this study were donated by the International Contraceptive Access Foundation, Turku, Finland under an unrestricted grant and the TCu380A IUDs were donated by Injeflex, São Paulo, Brazil. The donors do not have any participation in the elaboration of the protocol, conducting the study, analyzing the data, or writing the paper.
Identification
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