Abnormal CPR is associated with substantial risk of adverse perinatal outcomes. The test seems to be particularly useful for follow up of fetuses with sonographically diagnosed FGR.
Background
Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging–guided focused ultrasound surgery are minimally invasive therapies approved by the United States Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments. (NCT00995878, clinicaltrials.gov)
Objective
To summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment.
Study Design
Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n=57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n=34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected.
Results
Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P<.001). Of women undergoing focused ultrasound (n=43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1–7] vs 1 [1–4]; P=.002). Compared with those having focused ultrasound (n=39), women undergoing embolization (n=36) were more likely to use outpatient opioid (75% vs 21%; P<.001) and nonsteroidal anti-inflammatory medications (97% vs 67%; P<.001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6–14] vs 4 [2–7]; P<.001; days until returned to normal, 15 [10–29] vs 10 [10–15]; P=.02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% (42/49) of adverse events required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and lon...
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