Pregnancy Outcomes after Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata® System

Abstract

<h3>Study Objective</h3> To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids. <h3>Design</h3> Retrospective study. <h3>Setting</h3> Hospitals in Europe, the UK, Mexico and the US. <h3>Patients or Participants</h3> Women who reported pregnancies after undergoing TFA with the Sonata® System. <h3>Interventions</h3> TFA was used to ablate fibroids, both under clinical trial protocol and commercial usage. <h3>Measurements and Main Results</h3> To date, there have been 32 pregnancies representing 18 deliveries among 25 women who were treated with TFA. Four women conceived more than once post-ablation, and four conceived as a result of assisted reproductive technology (ART). Outcomes include 8 vaginal deliveries, 10 Cesarean sections, 3 therapeutic abortions, and 8 miscarriages (four occurring in a patient with a history of recurrent abortion and an immunologic disorder). Three women are either currently pregnant or have outcomes pending. There were no 5-minute Apgar scores <7, and all neonates weighed >2500 gms. All deliveries occurred at ≥37 weeks, except for one delivery at 35 6/7 weeks. There were no uterine ruptures or abnormal placentation and no reports of postpartum hemorrhage. One patient developed HELLP syndrome and had an emergent C/S after a trial of labor at term, while another underwent C/S for fetal macrosomia. Ablated fibroids included transmural, submucous and intramural myomata up to 6.6 cm in diameter. <h3>Conclusion</h3> Normal pregnancy outcomes at term have occurred after TFA with the Sonata System, including in women with recurrent abortion and in those undergoing ART.