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.
OBJECTIVE: To study the effectiveness and morbidity of adding hygroscopic cervical dilators to prostaglandin gel for cervical ripening and labor induction. STUDY DESIGN: Patients of at least 34 weeks' gestation with a medical indication for induction of labor and with a modified Bishop score of 5 or less were randomized to receive either prostaglandin gel or prostaglandin gel with hygroscopic cervical dilators. Primary outcomes were time to delivery, change in cervical score, and infection. Secondary outcomes included cesarean delivery rate and deliveries before 24 hours of induction. Continuous variables were analyzed by Wilcoxon sum rank test and categorical data by chi-square or Fisher exact test, with P < 0.05 being significant. RESULTS: Seventeen patients were randomized to intracervical prostaglandin alone and 23 patients received intracervical prostaglandin plus hygroscopic dilators. No demographic differences were noted between the groups. After six hours of ripening, the combined group achieved a greater change in Bishop score (3.6 vs. 2.1, P = 0.007) and tended to have a shorter induction time (21.7 vs. 26.4 hours, P = 0.085). The combined therapy group had a higher infection rate than the prostaglandin-only group (59% vs. 12%, P = 0.003). CONCLUSION: Combining cervical dilators with prostaglandin gel provides more effective cervical ripening and a more rapid induction to delivery interval than prostaglandin alone but with a significant and prohibitive rate of infection.
A case is described of a patient who presented with signs and symptoms suggestive of endometriosis. She underwent a diagnostic laparoscopy, which failed to identify any features of endometriosis. The patient subsequently underwent a 3D transvaginal sonogram that demonstrated evidence of a deep infiltrating endometriosis, affecting the right uterosacral ligament. This case demonstrates the diagnostic ability of 3D transvaginal sonography and, at the same time, the potential deficiency of laparoscopy to make the diagnosis of deep infiltrating endometriosis.
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