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...
Background: Uterine leiomyomas (fibroids) cause considerable symptoms in 30% to 50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroids often seek uterine-preserving treatments, but comparative effectiveness trials are lacking.Objective: To report treatment effectiveness and ovarian function after uterine artery embolization versus magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study.Study Design: Fibroid Interventions: Reducing Symptoms Today and Tomorrow, a randomized controlled trial of uterine artery embolization versus magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroids; women declining randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroids within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function.Results: During 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 magnetic resonance imaging-guided focused ultrasound surgery Laughlin-Tommaso et al.
Background
Uterine fibroids are an important source of morbidity for reproductive-aged women. Despite an increasing number of alternatives, hysterectomies account for about 75% of all fibroid interventional treatments. Evidence is lacking to help women and their health care providers decide among alternatives to hysterectomy. Fibroid Interventions: Reducing Symptoms Today and Tomorrow (NCT00995878, clinicaltrials.gov) is a randomized controlled trial to compare the safety, efficacy, and economics of 2 minimally invasive alternatives to hysterectomy: uterine artery embolization and magnetic resonance imaging–guided focused ultrasound surgery. Although randomized trials provide the highest level of evidence, they have been difficult to conduct in the United States for interventional fibroid treatments. Thus, contemporaneously recruiting women declining randomization may have value as an alternative strategy for comparative effectiveness research.
Objectives
To compare baseline characteristics of randomized participants with nonrandomized participants meeting the same enrollment criteria and to determine whether combining the 2 cohorts in a comprehensive cohort design would be useful for analysis.
Study Design
Premenopausal women with symptomatic uterine fibroids seeking interventional therapy at 3 American academic medical centers were randomized (1:1) in 2 strata based on calculated uterine volume (<700 cc3 and ≥700 cc3) to undergo embolization or focused ultrasound surgery. Women who met the same inclusion criteria but declined randomization were offered enrollment in a parallel cohort. Both cohorts were followed up for a maximum of 36 months after treatment. The measures addressed in this report were baseline demographics, symptoms, fibroid and uterine characteristics, and scores on validated quality-of-life measures.
Results
Of 723 women screened, 57 were randomized and 49 underwent treatment (27 with focused ultrasound and 22 with embolization). Seven of the 8 women randomized but not treated were assigned to embolization. Of 34 women in the parallel cohort, 16 elected focused ultrasound and 18 elected embolization. Compared with nonrandomized participants, randomized participants had higher mean body mass index (28.7 vs 25.3 kg/m2; P=.01) and were more likely to be gravid (77% vs 47%; P=.003) and smokers (42% vs 12%; P=.003). Age, race, uterine volume, number of fibroids, and baseline validated measures of general and disease-specific quality of life, pain, depression, and sexual function did not differ between the groups. When we performed a comprehensive cohort analysis and analyzed by treatment arm, the only baseline difference observed was a higher median McGill Pain Score among women undergoing focused ultrasound (10.5 vs 6; P=.03); a similar but nonsignificant trend was seen in Visual Analog Scale scores for pain (median, 39.0 vs 24.0; P=.06).
Conclusions
Using a comprehensive cohort analysis of study data could result in additional power and greater generalizability if results are adjusted fo...
Doubling the prophylactic iron dose is comparable to single dose in the prevention of iron deficiency anemia among women with twin gestations with more side effects.
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