Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Acknowledgments: We thank all the women who participated in this trial; the participating general practitioners, gynecologists, and hospitals; the research nurses; and the staff of the Dutch Consortium for Studies in Women’s Health and Reproduction.Peer reviewedPublisher PD

Diagnostic and prognostic aspects of tubal patency testing

Sjors Coppus keek in zijn onderzoek naar methoden om in vruchtbaarheidsonderzoek vrouwen met de hoogste kans op afwijkingen in de eileiders vroegtijdig op te sporen. Verminderde vruchtbaarheid kan een gevolg zijn van afsluiting van de eileiders. Daarom wordt in het oriënterend vruchtbaarheidsonderzoek vaak de doorgankelijkheid van de eileiders onderzocht. Bij de meerderheid van de vrouwen worden echter geen afwijkingen gevonden. Coppus onderzocht ook de waarde van diverse eileidertesten voor het voorspellen van een spontane zwangerschap

„EUebm“ – Integration einer europaweit harmonisierten Aus- und Fortbildung zu Evidenzbasierter Medizin (EbM) in die Krankenversorgung

Integrative concepts of teaching and learning with close reference to individual work routines are better suited to bring about attitudinal and behavioural modification--apart from a gain in knowledge and skills--than traditional educational approaches. All the same, the vast majority of continuing training courses in Evidence-based Medicine takes place during weekend courses or evening classes, outside the work environment. To counteract this deficit a modular curriculum framework for Evidence-based Medicine was developed within the scope of the European research project EUebm which aims to achieve both a harmonisation of EbM education and training in Europe and a better integration of education and training with everyday clinical practice. The modules of this curriculum are intended to seamlessly fit into our day-to-day clinical work for and with patients and thus facilitate close interaction between the actual clinical work and the learning of EbM techniques and their implementation into our own patients' care. On the basis of a survey conducted among all the project partners in Austria, England, Germany, Hungary, Italy, The Netherlands, Poland, Spain and Switzerland the demand for training and continuing education in EbM in the individual countries was identified. Taking into account the results of this survey as well as previous work such as, for example, the curriculum of the German Network for Evidence-based Medicine or material provided by the Centre for Evidence-based Medicine in Oxford, an Internet-based teaching and learning module on systematic reviews and meta-analyses was developed and tested in five of the participating countries. The test demonstrated that in this way harmonisation of EbM education and training and a better integration of training with our everyday clinical work becomes feasible

Diagnostic criteria for retained products of conception : a scoping review

Introduction Numerous studies have been performed assessing optimal treatment regimens for evacuating (retained) products of conception from the uterus, but standardized criteria for diagnosing retained products of conception (RPOC) are still lacking. We aim to provide an overview of diagnostic criteria in current literature, used to diagnose RPOC after induced first-trimester abortion or early pregnancy loss. Material and methods Pubmed, EMBASE, and the Cochrane library were searched systematically up until March 2020 for English articles reporting on induced abortion or early pregnancy loss. Articles not specifying diagnostic criteria used to assess completeness of treatment were excluded, as were conference abstracts, expert opinions, reviews, and case reports. Four elements of diagnostic criteria were described: diagnostic tools, parameters used within these tools, applied cut-off values, and timing of follow up. Additionally, a meta-analysis was performed assessing diagnostic qualities of the most often applied diagnostic tool and parameter. Results The search strategy yielded 1233 unique articles, of which 248 were included, with a total of 339 517 participants. In the 79 included randomized controlled trials, six diagnostic tools to assess RPOC were identified, combined in 14 ways, with 55 different cut-off values. In 169 observational studies, seven diagnostic tools were identified, used in 28 combinations, applying 89 different cut-off values. Transvaginal ultrasonographic measurement of endometrial thickness with a cut-off value of at least 15 mm indicating RPOC, was used most frequently. In the timing of follow-up there was great variation, with 55 and 107 different combinations in randomized controlled trials and observational studies, respectively. Assessment of treatment success was scheduled most often around 2 weeks after treatment. Diagnostic qualities of endometrial thickness of 15 mm or more was not adequately assessed. Conclusions There is wide variation in the way RPOC are assessed, and the criteria used to define RPOC following induced abortion and early pregnancy loss; ultrasonographic measurement of endometrial thickness, with a cut-off of 15 mm or more 2 weeks after primary treatment is the most widely used diagnostic approach. A meta-analysis on diagnostic accuracy of endometrial thickness of 15 mm or more did not lead to solid results. These findings can be a first step to develop a workable standard of establishing RPOC after induced abortion or early pregnancy loss

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

OBJECTIVE: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. STUDY DESIGN: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n=65) or expectant management (n=132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate RESULTS: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). CONCLUSION: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage

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

Objective: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Study design: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n = 65) or expectant management (n = 132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate Results: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). Conclusion: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage. (C) 2017 Elsevier B.V. All rights reserved

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial : PROSECCO trial, a study protocol

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial : PROSECCO trial, a study protocol

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015