Abstract
Objectives
To monitor pregnancy occurrence and outcomes among Nexplanon users in the United States
during standard clinical practice.
Study design
The Nexplanon Observational Risk Assessment (NORA) study was a large prospective cohort
study conducted in the United States (US). Study participants with a newly inserted
Nexplanon implant were recruited by health care professionals (HCPs) who had completed
the Nexplanon clinical training. Via a survey, study participants were followed up
at 6-month intervals for 36 months and 6 months after implant removal. Reported unintended
pregnancies were validated and classified as noninsertion, preinsertion, during-use,
or postremoval.
Results
Four hundred and twenty-eight HCPs in 47 states recruited 7364 Nexplanon users. Pregnancies
included one noninsertion, eight preinsertion, three during-use, and 14 postremoval
pregnancies; of these 26 pregnancies, 22 resulted in the birth of a healthy child,
two resulted in an induced abortion, one resulted in a spontaneous abortion, and one
resulted in an ectopic pregnancy. Six pregnancies occurred during-use (n = 3) or within 7 days following implant removal (n = 3), yielding a Pearl Index of 0.04 (95% CI, 0.02–0.09).
Conclusions
Nexplanon is an effective contraceptive in real-world users; the Pearl Index was 0.02
(95% CI, 0.00–0.06) for during-use pregnancies, and 0.04 when including pregnancies
that occurred within 7 days following implant removal.
Implications
This large real-world-use study indicates that Nexplanon is as effective as shown
in the preapproval clinical trials.
Keywords
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Article info
Publication history
Published online: December 15, 2022
Accepted:
November 30,
2022
Received in revised form:
November 28,
2022
Received:
February 16,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
