Study Objective: To analyze pregnancy delivery and safety outcomes after patient receipt of percutaneous, laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation (Lap-RFA) for symptomatic uterine myomas. Design: Case series (2010- 2017); evidence was obtained from 2 randomized, controlled trials (level I), 6 cohort studies (level II-2), and in commercial settings (level II-3). Setting: Multiple sites in the United States, Canada, Europe, and Latin America (university hospitals, community hospitals, and stand-alone surgery centers). Commercial cases were United States based and followed US Food and Drug Administration clearance of Lap-RFA. Patients: Premenopausal adult women with symptomatic uterine myoma types 1 through 6. Interventions: The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance. Measurements and Main Results: Safety unknowns included the safety of a full-term pregnancy for mother and baby, rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and vaginal versus cesarean delivery. A total of 28 women (mean age = 35.0 +/- 3.4 years) conceived a total of 30 times after Lap-RFA, either as part of a clinical study or in commercial settings. The number of myomas treated per patient ranged from 1 to 7. The diameter of treated myomas ranged from 0.9 to 11.0 cm. Most patients had 1 or 2 myomas, and most myomas were <= 5.5 cm in maximal diameter. The 30 pregnancies resulted in 26 full-term live births (86.7%), all healthy infants, with an equal distribution of vaginal and cesarean deliveries. Four (13.3%) spontaneous abortions occurred. No cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction were reported. One event each of placenta previa and postpartum hemorrhage were reported. Conclusion: Conception and safe, full-term pregnancy are achievable after Lap-RFA of symptomatic myomas. Additional large, rigorous, multivariate prospective studies that adjust for confounders and report pregnancy outcomes after symptomatic myoma treatment are needed. (C) 2019 AAGL. All rights reserved.

INTRODUCTION: More than 2,000 cases of laparoscopic intrabdominal ultrasound-guided radiofrequency ablation (Lap-RFA) of symptomatic myomas have been performed in the United States and internationally. Safe conception and childbearing following Lap-RFA are of great interest to patients, obstetrician-gynecologists, and reproductive endocrinologists and surgeons. Our purpose is to study the safety and gestational outcomes among reported pregnancies post Lap-RFA. METHODS: Gynecologic surgeons, who perform Lap-RFA, complete standardized data collection forms that capture specific details describing their consenting patients’ preoperative, intraoperative, and postoperative data as well as any pregnancy data. Reproductive outcomes have been collected and analyzed using descriptive statistics. RESULTS: Twenty-seven women (age range, 30-43 years old) conceived 28 times after Lap-RFA treatment. Of the 28 gestations, 23 (82.1%) resulted in full-term deliveries of healthy infants, 2 (7.1%) pregnancies are ongoing (due October and November), 2 (7.1%) pregnancies terminated in first-trimester spontaneous abortions, and 1 (3.6%) pregnancy terminated spontaneously in the second trimester. Time from treatment to conception ranged from 1 month to 28 months. Eleven (47.8%) of the births were by vaginal delivery. No cases of abnormal placentation or endometrial defect were observed. CONCLUSION: Accumulating evidence indicates that safe childbearing with full-term gestation can be achieved after Lap-RFA of symptomatic myomas. Continued collection of obstetric data from commercial Lap-RFA cases and Lap-RFA clinical trials are needed to support these preliminary findings.