Cost-effectiveness of curettage vs. expectant management in women with an incomplete evacuation after misoprostol treatment for first-trimester miscarriage: a randomized controlled trial and cohort study.

INTRODUCTION: Curettage is more effective than expectant management in women with suspected incomplete evacuation after misoprostol treatment for first-trimester miscarriage. The cost-effectiveness of curettage vs. expectant management in this group is unknown. MATERIAL AND METHODS: From June 2012 until July 2014 we conducted a randomized controlled trial and parallel cohort study in the Netherlands, comparing curettage with expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first-trimester miscarriage. Successful treatment was defined as a sonographic finding of an empty uterus 6 weeks after study entry, or an uneventful course. Cost-effectiveness and cost-utility analyses were performed. We included costs of healthcare utilization, informal care and lost productivity. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated using bootstrapping. RESULTS: We included 256 women from 27 hospitals; 95 curettage and 161 expectant management. Treatment was successful in 96% of the women treated with curettage vs. 83% of the women after expectant management (mean difference 13%, 95% confidence interval 5-20). Mean costs were significantly higher in the curettage group (mean difference €1157; 95% C confidence interval €955-1388). The incremental cost-effectiveness ratio for curettage vs. expectant management was €8586 per successfully treated woman. The cost-effectiveness acceptability curve showed that at a willingness-to-pay of €18 200/extra successfully treated women, the probability that curettage is cost-effective is 95%. CONCLUSIONS: Curettage is not cost-effective compared with expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment. This indicates that curettage in this group should be restrained.

Factors influencing women's preferences for subsequent management in the event of incomplete evacuation of the uterus after misoprostol treatment for miscarriage.

STUDY QUESTION: What affects women's treatment preferences in the management of an incomplete evacuation of the uterus after misoprostol treatment for a first-trimester miscarriage? SUMMARY ANSWER: Women's treatment preferences in the management of an incomplete evacuation of the uterus after misoprostol treatment for miscarriage are most strongly influenced by 'the risk of a reduced fertility' followed by 'the probability of success'. WHAT IS KNOWN ALREADY: Available treatment options in miscarriage are surgical, medical or expectant management. Treatment with misoprostol leads to an incomplete evacuation of the uterus and additional surgical treatment in 20-50% of women. To our knowledge, women's preferences for subsequent treatment of an incomplete evacuation of the uterus after misoprostol treatment for miscarriage have not been studied yet. STUDY DESIGN, SIZE, DURATION: Between April 2014 and January 2015, we conducted a prospective nationwide multicentre discrete-choice experiment (DCE). DCEs have become the most frequently applied approach for studying patient preferences in health care. In our DCE, which considerers five attributes, a target sample size was calculated including 20 patients per attribute for the main analysis. We intended to include 25% more patients, i.e. a total of 125 thus enabling us to assess heterogeneity of treatment choices. PARTICIPANTS/MATERIALS, SETTING, METHODS: All women visiting the outpatient clinic with first-trimester miscarriage or incomplete miscarriage were invited to participate in the study. Women under 18 years of age, women who were unable to understand the Dutch questionnaire or women who already had received a treatment for the current miscarriage were excluded. Women's preferences were assessed using a DCE. A literature review, expert opinions and interviews with women from the general population were used to define relevant treatment characteristics. Five attributes were selected: (i) certainty about the duration of convalescence; (ii) number of days of bleeding after treatment; (iii) probability of success (empty uterus after treatment); (iv) risk of reduced fertility and (v) risk of complications requiring more time or readmission to hospital. Fourteen scenarios using these attributes were selected in the DCE. Each of these scenarios presented two treatment options, while treatment characteristics varied between the 14 scenarios. For each scenario, respondents were asked to choose the preferred treatment option. The importance of each attribute was analysed, and preference heterogeneity was investigated through latent-class analysis. MAIN RESULTS AND THE ROLE OF CHANCE: One hundred and eighty-six women were included of whom 128 completed the DCE (69% response rate). The two attributes with the greatest effect on their preference were, probability of success and risk of reduced fertility. The latent-class analysis revealed two subgroups of patients with different preference patterns. Forty per cent of women were more influenced by treatment success and 59% were more influenced by risk. LIMITATIONS, REASONS FOR CAUTION: Most women were highly educated and were of Dutch origin, which limits the generalizability of our findings. Women with lower education levels, other cultural backgrounds and/or different previous experiences may differ from our findings. WIDER IMPLICATIONS OF THE FINDINGS: Patients preferences should be addressed when counselling patients with an incomplete miscarriage after misoprostol treatment. STUDY FUNDING/COMPETING INTEREST(S): This study was embedded in the MisoREST trial, and funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl. TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial.

BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled trials reported outcomes in terms of health-related quality of life, clinical outcomes, efficacy, and cost-effectiveness after 1, 2, and 5 years of follow-up. OBJECTIVE: The purpose of this study was to compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. STUDY DESIGN: In all, 28 Dutch hospitals recruited patients with symptomatic uterine fibroids who were eligible for hysterectomy. Patients were 1:1 randomly assigned to uterine artery embolization or hysterectomy. The outcomes assessed at 10 years postintervention were reintervention rates, health-related quality of life, and patient satisfaction, which were obtained through validated questionnaires. Study outcomes were analyzed according to original treatment assignment (intention to treat). RESULTS: A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. CONCLUSION: In about two thirds of uterine artery embolization-treated patients with symptomatic uterine fibroids a hysterectomy can be avoided. Health-related quality of life 10 years after uterine artery embolization or hysterectomy remained comparably stable. Uterine artery embolization is a well-documented and less invasive alternative to hysterectomy for symptomatic uterine fibroids on which eligible patients should be counseled.

The Effect of Creatine Kinase Inhibition on Contractile Properties of Human Resistance Arteries.

BACKGROUND: Creatine kinase (CK) is a main predictor of blood pressure, and this is thought to largely depend on high resistance artery contractility. We previously reported an association between vascular contractility and CK in normotensive pregnancy, but pregnancy is a strong CK inducer, and data on human hypertension are lacking. Therefore, we further explored CK-dependency of vascular contractility outside the context of pregnancy in normotensive and hypertensive women. METHODS AND RESULTS: Nineteen consecutive women, mean age 42 years (SE 1.3), mean systolic/diastolic blood pressure respectively 142.6 (SE 5.9)/85.6 (3.4) mm Hg (9 hypertensive), donated an omental fat sample during abdominal surgery. We compared vasodilation after the specific CK inhibitor 2,4-dinitro-1-fluorobenzene (DNFB; 10(-6) mol/l) to sodium nitroprusside (10(-6) mol/l) in isolated resistance arteries using a wire myograph. Additionally, we assessed predictors of vasoconstrictive force. DNFB reduced vascular contractility to 24.3% (SE 4.4), P < 0.001, compared to baseline. Sodium nitroprusside reduced contractility to 89.8% (SE 2.3). Maximum contractile force correlated with DNFB effect as a measure of CK (r = 0.8), and with vessel diameter (r = 0.7). The increase in contractile force was 16.5 mN [9.1-23.9] per unit DNFB effect in univariable and 10.35 mN [2.10-18.60] in multivariable regression analysis. CONCLUSION: This study extends on our previous findings in pregnant normotensive women of CK-dependent microvascular contractility, indicating that CK contributes significantly to resistance artery contractility across human normotension and primary hypertension outside the context of pregnancy. Further studies should explore the effect of CK inhibitors on clinical blood pressure.

Randomized comparison of health-related quality of life in women with ectopic pregnancy or pregnancy of unknown location treated with systemic methotrexate or expectant management.

OBJECTIVE: To study the impact on health-related quality of life (HRQoL) of treatment with systemic methotrexate (MTX) or expectant management in women with ectopic pregnancy or pregnancy of unknown location (PUL) with low and plateauing serum hCG concentrations. STUDY DESIGN: HRQoL was assessed alongside a randomized clinical trial (RCT) with the use of standard self-administered psychometric measure questionnaires. PATIENTS AND SETTING: All women who participated in the multicenter RCT comparing treatment with systemic MTX to expectant management in women with ectopic pregnancy or persisting PUL were eligible for the HRQoL measurements. MAIN OUTCOME MEASURE: HRQoL measures of three standardized questionnaires (SF-36, RSCL, HADS). RESULTS: Data were available for 64 of 73 women (78%) randomized in the RCT. We found no difference in HRQoL between the two treatment groups. The need for additional treatment, i.e. additional MTX injections or surgical intervention, had no impact on HRQoL. CONCLUSION: Women treated with MTX or expectant management for an ectopic pregnancy or persisting PUL have comparable quality of life.

Early pregnancy care over time: should we promote an early pregnancy assessment unit?

In this observational study, the effect of the introduction of the first Early Pregnancy Assessment Unit (EPAU) in a university hospital in The Netherlands in 2008 on early pregnancy care is analysed. Derivatives of quality of care were measured before and after the establishment of the EPAU, with the aim of reducing unnecessary care. Care within three time periods was measured: 2006, 2009 and 2012. In 2006, 14% of women who had experienced a miscarriage were admitted to the hospital, whereas in 2009 and 2012 no women were admitted. The surgical management rate for miscarriage decreased from 79% (2006) to 6% (2009) and 28% (2012). Karyotyping of couples who had experienced recurrent miscarriage decreased from 100% (2006) to 17% (2009) and 33% (2012). The surgical management rate for ectopic pregnancy decreased from 50% (2006) to 25% (2009) and 29% (2012). The mean total cost per woman treated in 2006 was €1111 (95% CI €808 to 1426), €436 (95% CI €307 to 590) in 2009 and €633 (95% CI €586 to 788) in 2012. We can therefore conclude that an EPAU results in higher quality and cost-effective care, and has a positive effect on early pregnancy care.

Hypertension risk in Dutch women with symptomatic uterine fibroids.

BACKGROUND: Female-specific risk factors for cardiovascular disease are understudied. We assessed whether women with uterine fibroids have a greater hypertension risk, independent of the shared risk factors for both conditions. METHODS: Blood pressure was measured in women scheduled for fibroid surgery compared to women scheduled for nonfibroid gynecological surgery and women randomly sampled from the general population. We used multivariable binary logistic regression to assess whether hypertension was more common with surgically treated fibroids, independent of age, body mass index, and African ancestry. RESULTS: We included 1,342 women (542 of African ancestry), of which 272 scheduled for fibroid surgery, 385 controls scheduled for nonfibroid gynecological surgery, and 685 random population controls, with a mean age (SD) of, respectively, 43.4 (6.6), 41.3 (10.2), and 45.1 (6.6) years; and a mean body mass index (SD) of, respectively, 27.4 (5.3), 25.7 (5.7), and 28.2 (5.6) kg/m(2). Hypertension was found more frequently with surgically treated fibroids, with an occurrence of 41.9% in women with fibroids vs. 27.5% in surgical controls, and 28.3% in population controls (P < 0.001 for fibroids vs. controls). The association with hypertension was independent of age, body mass index, and African ancestry (odds ratio, 2.4; 95% confidence interval, 1.7-3.4). CONCLUSIONS: Hypertension risk is higher in Dutch women with surgically treated fibroids than in surgery or population controls, independent of age, body mass index, and African ancestry. Our data add to the body of evidence indicating that women with uterine fibroids are eligible for hypertension screening.

The estimated volume of the fibroid uterus: a comparison of ultrasound and bimanual examination versus volume at MRI or hysterectomy.

OBJECTIVES: The volume of a fibroid uterus before performing hysterectomy is typically estimated through bimanual examination and confirmed by ultrasonography. This study compares estimated volumes by bimanual examination and ultrasound examination with MRI and actual volumes obtained from histopathology, as gold standards. STUDY DESIGN: We used data from a previous prospective randomized multi-center trial that compared hysterectomy and uterine artery embolization (UAE) for the treatment of symptomatic fibroids. All patients underwent bimanual vaginal examination and pelvic ultrasonography. Those women randomized to UAE received a pelvic MRI. For women randomized to hysterectomy, the exact uterine volume was based on histopathologic examination. We compared the calculated volumes based on ultrasound parameters and estimated volume based on bimanual examination with either the calculated volumes of the pelvic MRI parameters or the calculated volume based on the exact weight during histological examinations. RESULTS: Our study demonstrated poor agreement between ultrasound and bimanual examination compared with exact volume during histopathologic examination and MRI-based volume. The agreement within the patient group with uterine volume >233 g and >747 g was fair to good. For those women with a uterine volume between 233 and 747 g, the agreement was poor when comparing bimanual estimates with volume obtained from MRI or histolopathologic examination. Within this volume group, the agreement on uterine volume between ultrasound and MRI or histopathologic examination was fair. CONCLUSIONS: Our study shows that uterine volume as estimated by ultrasound and bimanual examination can be used for small or large uteri. For uteri with an intermediate volume, bimanual examination and ultrasound are less reliable.

Practice variation in the management of first trimester miscarriage in the Netherlands: a nationwide survey.

Objectives. To survey practice variation in the management of first trimester miscarriage in The Netherlands. Methods. We sent an online questionnaire to gynecologists in eight academic, 37 nonacademic teaching, and 47 nonteaching hospitals. Main outcome measures were availability of a local protocol; estimated number of patients treated with curettage, misoprostol, or expectant management; misoprostol regimen; and estimated number of curettages performed after initial misoprostol treatment. Outcomes were compared to the results of a previous nationwide survey. Results. The response rate was 100%. A miscarriage protocol was present in all academic hospitals, 68% of nonacademic teaching hospitals, and 38% of nonteaching hospitals (P = 0.008). Misoprostol was first-choice treatment for 41% of patients in academic hospitals versus 34% and 27% in teaching-and nonteaching hospitals (P = 0.045). There were 23 different misoprostol regimens. Curettage was first-choice treatment in 29% of patients in academic hospitals versus 46% and 50% in nonacademic teaching or nonteaching hospitals (P = 0.007). In 30% of patients, initial misoprostol treatment was followed by curettage. Conclusions. Although the percentage of gynaecologists who are aware of the availability of misoprostol for miscarriage treatment has doubled to almost 100% since 2005, practice variation is still large. This practice variation underlines the need for a national guideline.

Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial.

BACKGROUND: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. METHODS: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. FINDINGS: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60·7% after salpingotomy and 56·2% after salpingectomy (fecundity rate ratio 1·06, 95% CI 0·81-1·38; log-rank p=0·678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15·0, 2·0-113·4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1·6, 0·8-3·3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. INTERPRETATION: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW), Region Västra Götaland Health & Medical Care Committee.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial.

BACKGROUND: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. METHODS/DESIGN: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. DISCUSSION: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. TRIAL REGISTRATION: Dutch Trial Register: NTR3110.

Epidural analgesia versus patient-controlled analgesia for pain relief in uterine artery embolization for uterine fibroids: a decision analysis.

PURPOSE: This study was designed to compare the costs and effects of epidural analgesia (EDA) to those of patient-controlled intravenous analgesia (PCA) for postintervention pain relief in women having uterine artery embolization (UAE) for systematic uterine fibroids. METHODS: Cost-effectiveness analysis (CEA) based on data from the literature by constructing a decision tree to model the clinical pathways for estimating the effects and costs of treatment with EDA and PCA. Literature on EDA for pain-relief after UAE was missing, and therefore, data on EDA for abdominal surgery were used. Outcome measures were compared costs to reduce one point in visual analogue score (VAS) or numeric rating scale (NRS) for pain 6 and 24 h after UAE and risk for complications. RESULTS: Six hours after the intervention, the VAS was 3.56 when using PCA and 2.0 when using EDA. The costs for pain relief in women undergoing UAE with PCA and EDA were 191 and 355, respectively. The costs for EDA to reduce the VAS score 6 h after the intervention with one point compared with PCA were 105 and 179 after 24 h. The risk of having a complication was 2.45 times higher when using EDA. CONCLUSIONS: The results of this indirect comparison of EDA for abdominal surgery with PCA for UAE show that EDA would provide superior analgesia for post UAE pain at 6 and 24 h but with higher costs and an increased risk of complications.

The effect of treatment preference and treatment allocation on patients' health-related quality of life in the randomized EMMY trial.

OBJECTIVES: To determine the effect of preference and treatment allocation on health-related quality of life (HRQOL) in patients in the randomized EMMY trial of hysterectomy versus uterine artery embolization (UAE) for symptomatic uterine fibroids. STUDY DESIGN: We invited 349 patients eligible for trial participation, of which 177 agreed to participate (the 'randomized group'). Within the randomized group, patients were allocated to. UAE (n=88) or hysterectomy (n=89). The remaining 172 patients refused randomization and received the treatment of their preference (varying from hysterectomy to no treatment at all), of which 103 patients agreed to fill in questionnaires (the 'preference group'). Patients' treatment preferences and HRQOL were assessed at baseline and the patients were prospectively followed to evaluate HRQOL at 12 months after treatment. RESULTS: At baseline, most patients in the randomized group preferred UAE: 115/177 (65%). In the preference group most patients preferred hysterectomy: 100/172 (58%). At 12 months there was no effect of having had the preferred treatment on HRQOL, neither in the randomized nor in the preference group. The randomized group improved significantly in both mental and physical health, compared to baseline. In the preference group, only mental health improved compared to baseline, while physical health did not improve significantly. CONCLUSIONS: In a randomized trial comparing UAE and hysterectomy for symptomatic fibroids, the pre-randomization preference for a specific treatment did not affect HRQOL. Trial participants improved better on physical HRQOL than women who refused to participate.

Ectopic pregnancy: how the diagnostic and therapeutic management has changed.

Nowadays ectopic pregnancy often can be diagnosed before the woman's condition has deteriorated, which has altered the former clinical picture of a life-threatening disease into a more benign condition. This review describes the historical developments in the diagnostic and therapeutic management of ectopic pregnancy leading up to current clinical practice. The first attempts to diagnose ectopic pregnancy originate from the beginning of the 20th century.

Review of nonsurgical/minimally invasive treatments for uterine fibroids.

PURPOSE OF REVIEW: Many nonsurgical and minimally invasive therapies for symptomatic uterine fibroids have been introduced. The purpose of this review is to summarize the recent evidence on these techniques, and their effect on fibroid volume, menorrhagia, health related quality of life (HRQOL), fertility and their risk of complications. RECENT FINDINGS: Laparoscopic or hysteroscopic myomectomy and uterine artery embolization (UAE) have been the most widely studied and all show significantly beneficial effects on menorrhagia and HRQOL, with a low incidence of complications. Magnetic resonance-guided high-intensity focused ultrasound (MRgFUS), myolysis/radiofrequency ablation (RFA) and laparoscopic or vaginal occlusion of uterine vessels (L/V-OUA) are newer interventions, with a smaller body of evidence.For women wishing to retain their childbearing possibilities, myomectomy is the best-studied intervention. Hysteroscopic myomectomy is specifically indicated in submucosal fibroids with subsequently beneficial effects on fertility. The use of UAE in fertile women has not been studied extensively, but evidence points toward an increase in adverse pregnancy outcomes after UAE compared with myomectomy. For MRgFUS, myolysis/RFA and L/V-OUA more evidence is needed. SUMMARY: Laparoscopic/hysteroscopic myomectomy and UAE are evidence-based beneficial alternative therapies for symptomatic uterine fibroids. Until more evidence is available, myomectomy stays the option of choice for women who wish to conceive in the future.

Severe maternal morbidity in ectopic pregnancy is not associated with maternal factors but may be associated with quality of care.

OBJECTIVE: To study the association between patient-related risk factors and severe maternal morbidity in women with tubal ectopic pregnancy (EP). Furthermore, to identify substandard care factors in clinical care management of EP. DESIGN: Case-control study. SETTING: Not applicable. PATIENT(S): Case subjects were from the LEMMoN study, a prospective nationwide cohort study. Control subjects were from the ESEP study, an international multicenter randomized controlled trial. INTERVENTION(S): Case subjects were women with tubal EP complicated by severe intra-abdominal hemorrhage necessitating blood transfusion of ≥4 units of packed red blood cells peri- or postoperatively. Control subjects were women with tubal EP who were hemodynamically stable and surgically treated. MAIN OUTCOME MEASURE(S): Patient-related risk factors as: maternal age, gestational age, previous EP, Chlamydia infection, pelvic inflammatory disease, assisted reproductive techniques, and serum hCG level. Substandard care categories classified as unawareness of the clinician, misdiagnosis, and nonadherence to the guideline on EP. RESULT(S): Twenty-nine case subjects and 99 control subjects were included. The mean serum hCG level was significantly higher in case subjects compared with control subjects, but we found no reliable cutoff level of serum hCG to rule out maternal morbidity. Other risk factors did not differ significantly. Substandard care was scored more often in case subjects (43%) than in control subjects (14%), mainly concerning misdiagnosis. CONCLUSION(S): No patient-related risk factors for severe intra-abdominal hemorrhage in women with tubal EP were identified. Our findings underpin the importance of awareness of EP among young fertile women and care providers and clinical care management according to the guidelines to prevent severe maternal morbidity.

Open-access transvaginal sonography in women of reproductive age with abnormal vaginal bleeding: a descriptive study in general practice.

BACKGROUND: Diagnostic ultrasonography is used by GPs in approximately 10% of patients of reproductive age with abnormal vaginal bleeding. Transvaginal sonography is recommended as a first-line diagnostic instrument for assessing uterine pathology. AIM: To assess if findings resulting from open-access sonography were in agreement with the GPs' working hypotheses and if these findings contributed to GPs' management. DESIGN AND SETTING: Prospective observational cohort study of GPs working in the health district of the Academic Medical Center, Amsterdam and their patients consulting with abnormal vaginal bleeding. METHOD: Data on patients' history, GPs' primary working hypotheses, and intended management were recorded. After sonography, GPs recorded their actual management. RESULTS: A total of 122 patients were included by 18 GPs from June 2003 to December 2004. Data from 89 patients were available for analysis. The GPs' working hypotheses implied 'no structural pathology' in 65/89 patients, and 'fibroids' in 24/89 patients. Sonographic findings were confirmed in 50/65 patients where 'no structural pathology', and in 14/24 of those where 'fibroids' were expected. Initially, GPs had intended to refer nine patients to a gynaecologist. Actual management after sonographic assessment was watchful waiting or drug therapy in 57/89 patients. Eighty-nine per cent of these patients had normal sonographic findings. The actual referral rate rose to 27/89 patients. In 17 referred patients, sonographic findings were suggestive of intracavitary abnormalities. CONCLUSION: Open-access sonography contributed to more accurate diagnoses and improved GPs' management of women with abnormal vaginal bleeding.

Uterine artery embolization versus surgery in the treatment of symptomatic fibroids: a systematic review and metaanalysis.

OBJECTIVE: To summarize the evidence on short-, mid-, and long-term results up to 5 years of uterine artery embolization in comparison to surgery. STUDY DESIGN: We searched the CENTRAL, MEDLINE and EMBASE databases for randomized clinical trials comparing uterine artery embolization with hysterectomy/myomectomy in premenopausal women with heavy menstrual bleeding caused by symptomatic uterine fibroids, written from September 1995 to November 2010. Two reviewers independently assessed methodologic quality and extracted data from included trials. RESULTS: Four randomized controlled trials with a total of 515 patients were included. On the short-term, uterine artery embolization showed fewer blood loss, shorter hospital stay, and quicker resumption of work. Mid- and long-term results showed comparable health-related quality of life results and a higher reintervention rate in the uterine artery embolization group, whereas both groups were equally satisfied. CONCLUSION: Uterine artery embolization has short-term advantages over surgery. On the mid- and long-term the benefits were similar, except for a higher reintervention rate after uterine artery embolization.

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial.

OBJECTIVE: The purpose of this study was to compare clinical outcome and health related quality of life (HRQOL) 5 years after uterine artery embolization (UAE) or hysterectomy in the treatment of menorrhagia caused by uterine fibroids. STUDY DESIGN: Patients with symptomatic uterine fibroids who were eligible for hysterectomy were assigned randomly 1:1 to hysterectomy or UAE. Endpoints after 5 years were reintervention rates, menorrhagia, and HRQOL measures that were assessed by validated questionnaires. RESULTS: Patients were assigned randomly to UAE (n = 88) or hysterectomy (n = 89). Five years after treatment 23 of 81 UAE patients (28.4%) had undergone a hysterectomy because of insufficient improvement of complaints (24.7% after successful UAE). HRQOL measures improved significantly and remained stable until the 5-year follow-up evaluation, with no differences between the groups. UAE had a positive effect both on urinary and defecation function. CONCLUSION: UAE is a well-established alternative to hysterectomy about which patients should be counseled.