Laparoscopic Trocars: Marketed Versus True Dimensions-A Descriptive Study.

STUDY OBJECTIVE: To establish true dimensions of single-use laparoscopic trocars compared with marketed dimensions, calculate corresponding incision sizes, examine what trocar size categories are based on, and outline accessibility of information regarding true dimensions. DESIGN: Descriptive study. SETTING: Laparoscopic disposable trocars available in North America and Europe are marketed in several distinct categories. In practice, trocars in the same-size category exhibit different functionality (ability to introduce instruments/needles and retrieve specimens) and warrant different incision lengths. PATIENTS: Not applicable. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: True dimensions for 125 trocars (bladeless, optical, and balloon) were obtained from 9 vendors covering 8 marketed size categories (3-, 3.5-, 5-, 8-, 10-, 11-, 12-, and 15-mm trocars). On average, true inner cannula diameter was 0.92 mm wider (SD, 0.41 mm; range, 0-2.4 mm) than the marketed size category, with the widest range in the 5 mm category. For 5-mm trocars, mean true inner diameter was 6.1 mm (SD, 0.45; range, 5.5-7.4) and true outer diameter 8.3 mm (SD, 0.71; range, 8.0-10.7). For 12-mm trocars, mean true inner diameter was 13.0 mm (SD, 0.21; range, 12-13.3) and outer diameter 15.3 mm (SD, 0.48; range, 14.4-16.8). Five-mm trocars necessitate a mean incision size of 13.0 mm (SD, 1.1; range, 12.1-16.8) and 12-mm trocars a mean incision of 24.0 mm (SD, 0.75; range, 22.6-26.4). No vendors stated actual diameters on company website or catalog. In one instance the Instructions For Use document contained the true inner diameter. CONCLUSION: Trocar size categories give a false sense of standardization when in actuality there are considerable within-category differences in both inner and outer diameters, corresponding to differences in functionality and required incision sizes. There is no universally applied definition for trocar size categories. Accessibility of information on true dimensions is limited.

Hormonal support in women with Asherman syndrome does not lead to better outcomes: A randomized trial.

Purpose: The purpose of the study was to investigate if adjuvant hormones after successful adhesiolysis lead to a reduction in spontaneous recurrence of adhesions and influence reproductive outcomes. Methods: A single-blind randomized controlled trial comparing administration of oral estrogen (the usual care group) with not giving estrogen (no estrogen) in women after successful adhesiolysis for Asherman syndrome. Women were included between September 2013 and February 2017, with a follow-up of 3 years to monitor recurrences and reproductive outcomes. Analyses were based on an intention to treat analyses. This study was registered under NL9655. Results: A total of 114 women were included. At 1 year, virtually all patients (except 3) were either having a recurrence or were pregnant. Women who did not receive estrogen did not have more recurrences of adhesions in the first year prior to pregnancy (66.1% in the usual care group, 52.7% in the no-estrogen group, p = 0.15). Of the women in usual care, 89.8% got pregnant within 3 years, and 67.8% got a living child; this was 83.6% and 60.0%, respectively, in the no-estrogen group (p = 0.33 and p = 0.39, respectively). Conclusion: Usual care does not lead to better outcomes as compared with not giving exogenous estrogen but is associated with side effects.

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

BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.

Removal of Essure Sterilization Devices: A Retrospective Cohort Study in the Netherlands.

STUDY OBJECTIVE: To analyze short-term effectiveness and symptom resolution after surgical removal of Essure (Bayer AG, Leverkusen, Germany) sterilization devices. DESIGN: A single-center retrospective cohort study (Canadian Task Force classification III). SETTING: A large secondary care teaching hospital in the Netherlands. PATIENTS: All patients who underwent surgical removal of Essure devices between January 2009 and December 2015. INTERVENTIONS: Surgical removal of Essure devices was predominantly performed by laparoscopic surgery. In the majority of patients, Essure devices were removed by performing bilateral salpingectomy (66.6%). MEASUREMENTS AND MAIN RESULTS: Data regarding patient characteristics, symptoms, the insertion procedure, the removal procedure, results of the pathological assessment, and follow-up were extracted from patient files. A total of 93 patients had Essure devices removed in the selected period. The onset of symptoms after Essure sterilization was variable. The most frequently reported symptom was abdominal pain (69.9%) followed by lower back pain and fatigue. Most patients reported multiple symptoms; 39.8% of women reported complete relief of symptoms after removal surgery, whereas 15.1% did not notice any relief in symptoms. CONCLUSION: Six weeks after removal surgery, 39.8% of patients reported complete resolution of symptoms. Further research to reported symptoms after Essure sterilization and symptom resolution after removal surgery is necessary to inform both patients and gynecologists in order to make a well-considered decision about taking the risks of (major) surgery and the expected benefits of removal.

Magnetic Resonance Imaging-Guided High-Intensity Focused Ultrasound is a Noninvasive Treatment Modality for Patients with Abdominal Wall Endometriosis.

Two women (29 and 35 years of age) presented with an abdominal wall mass in close proximity to a cesarean scar. The main complaints consisted of pain at the site of the mass with catamenial exacerbations. Clinical and imaging findings were consistent with abdominal wall endometriosis in both cases. First, hormonal treatment was started, which proved unsuccessful. Typically, at this point, the proposed treatment would be wide surgical excision. Alternatively, magnetic resonance imaging-guided high-intensity focused ultrasound treatment was offered with the goal to diminish pain complaints noninvasively. Upon treatment, both patients' complaints diminished although some cyclic pain persisted. Overall, these cases show that magnetic resonance imaging-guided high-intensity focused ultrasound can be used as a noninvasive treatment method to reduce complaints in patients with abdominal wall endometriosis.

Changes in the Uterine Scar during the First Year after a Caesarean Section: A Prospective Longitudinal Study.

AIM: To study changes in a ceasarean section (CS) scar during the first year after a CS using gel installation sonography (GIS). METHODS: Proof-of-concept study, prospective cohort study. Twenty women who delivered by their first CS were evaluated by both transvaginal sonography and GIS 2 months and 1 year after CS. A niche was defined as an anechogenic space at the uterine caesarean scar with a depth >2 mm. The primary outcome was any change in the thickness of the residual myometrium (RMT) as evaluated by GIS. RESULTS: Mean RMT changed in time from 11.9 mm at 2 months to 6.5 mm at 12 months after the CS (p < 0.001). Niche prevalence did not change. The adjacent myometrium (AM) reduced from 15 to 12.4 mm (p = 0.04). The ratio between RMT and AM with GIS decreased from 0.80 at 2 months to 0.54 at 12 months (p = 0.002). CONCLUSION: RMT thickness, the adjacent myometium and the ratio between the RMT and AM reduces from 2 to 12 months after a CS. The prevalence did not change. This needs to be taken into account when deciding on the timing of niche measurement and the interpretation of the RMT.

Long-term risk of endometrial cancer following postmenopausal bleeding and reassuring endometrial biopsy.

INTRODUCTION: Women with postmenopausal bleeding and endometrial thickness >4 mm undergo endometrial sampling to exclude endometrial cancer. The aim of this study is to investigate the relative risk of developing endometrial cancer in a prospective cohort after initial work-up for postmenopausal bleeding showing reassuring histology or insufficient sampling. MATERIAL AND METHODS: All women presenting with postmenopausal bleeding were prospectively included from January 2009 to April 2011. Follow-up data were collected from patient charts and PALGA (Dutch Pathology Registry). Hazard ratios for endometrial cancer were determined by calculating standardized incidence ratios. RESULTS: A total of 668 women were included and 568 women were available for follow-up [median follow-up time 47 (range 7-63) months]. Women who presented with postmenopausal bleeding, endometrial thickness >4 mm and hyperplasia without atypia on biopsy at the first presentation showed a significantly increased risk (standardized incidence ratio 17.15, 95% confidence interval 1.96-61.93) of being diagnosed with endometrial cancer during the first four years of follow up compared with the age-specific population. All women that developed endometrial cancer after initial reassuring histology presented with recurrent postmenopausal bleeding. None of the women with endometrial thickness >4 mm and no or insufficient sample for histology at the first presentation developed endometrial cancer during the follow up. CONCLUSIONS: Although in general, women with endometrial hyperplasia without atypia are considered to have a low risk for cancer, we observed a significant long-term risk of endometrial cancer after postmenopausal bleeding. Whether additional diagnostics or a more stringent follow-up regimen would be cost-effective, needs to be studied.

The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study.

BACKGROUND: The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. DESIGN: We performed a preclinical validation study. SETTING: This study was performed at the University hospital. SAMPLE: Animal, cadaver. METHODS: Together with technical engineers, we designed a new medical device that involves a knife and cuts back from buttock toward introitus, in contrast to the conventional episiotomy. We optimized the design and its performance in consecutive animal and cadaver studies. MAIN OUTCOME MEASURES: Ability to perform a standardized incision, ease of use. RESULTS: After multiple adjustments, based on the results of multiple animal and cadaver studies, a medical device was developed to perform a standardized clean-cut episiotomy of 4-6 cm length. CONCLUSION: We have shown that optimizing the technical performance and safety of an innovative device in animals, prior to opposing patients to its potential hazards, is feasible. Our design optimizing study can be used as a model for the pre-clinical validation of future innovative medical devices.

Outcomes of pregnancies in women with hysteroscopically placed micro-inserts in situ.

This was a retrospective review of all pregnancies reported after Essure in situ in the Netherlands. Pregnancies included those that were unintentional (resulting from lack of protocol adherence and/or misread confirmation tests) and those that were intentional (resulting from off-label use of Essure micro-inserts for hydrosalpinx closure before in vitro fertilization/intracytoplasmic sperm injection with embryo transfer or in vitro fertilization with embryo transfer after regret of sterilization). The outcomes of 50 pregnancies in women with 1 or 2 micro-inserts in situ were evaluated. Eight unintended pregnancies and 18 intended pregnancies resulted in birth of a full-term healthy baby. Seven infants were delivered via cesarean-section. Two women delivered prematurely by C-section, (singleton after 34 weeks 1 day, twins after 35 weeks 3 days). All babies are healthy and without any congenital anomalies. There were 2 stillbirths after 20 weeks; however, it is unlikely that this was related to the presence of the micro-inserts. In conclusion, it is unlikely that the presence of intratubal micro-inserts interferes with implantation and the developing amniotic sac and fetus.

Waste analysis and energy use estimation during MR-HIFU treatment: first steps towards calculating total environmental impact.

OBJECTIVES: To assess the environmental impact of the non-invasive Magnetic Resonance image-guided High-Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids, we aimed to perform a full Life Cycle Assessment (LCA). However, as a full LCA was not feasible at this time, we evaluated the CO2 (carbon dioxide) emission from the MRI scanner, MR-HIFU device, and the medication used, and analyzed solid waste produced during treatment. METHODS: Our functional unit was one uterine fibroid MR-HIFU treatment. The moment the patient entered the day care-unit until she left, defined our boundaries of investigation. We retrospectively collected data from 25 treatments to assess the CO2 emission based on the energy used by the MRI scanner and MR-HIFU device and the amount and type of medication administered. Solid waste was prospectively collected from five treatments. RESULTS: During an MR-HIFU treatment, the MRI scanner and MR-HIFU device produced 33.2 ± 8.7 kg of CO2 emission and medication administered 0.13 ± 0.04 kg. A uterine fibroid MR-HIFU treatment produced 1.2 kg (range 1.1-1.4) of solid waste. CONCLUSIONS: Environmental impact should ideally be analyzed for all (new) medical treatments. By assessing part of the CO2 emission and solid waste produced, we have taken the first steps towards analyzing the total environmental impact of the MR-HIFU treatment of uterine fibroids. These data can contribute to future studies comparing the results of MR-HIFU LCAs with LCAs of other uterine fibroid therapies. CRITICAL RELEVANCE STATEMENT: In addition to (cost-) effectiveness, the environmental impact of new treatments should be assessed. We took the first steps towards analyzing the total environmental impact of uterine fibroid MR-HIFU. KEY POINTS: • Life Cycle Assessments (LCAs) should be performed for all (new) medical treatments. • We took the first steps towards analyzing the environmental impact of uterine fibroid MR-HIFU. • Energy used by the MRI scanner and MR-HIFU device corresponded to 33.2 ± 8.7 kg of CO2 emission.

Factors attributing to the failure of endometrial sampling in women with postmenopausal bleeding.

OBJECTIVE: To determine which doctor- and patient-related factors affect failure of outpatient endometrial sampling in women with postmenopausal bleeding, and to develop a multivariable prediction model to select women with a high probability of failed sampling. DESIGN: Prospective multicenter cohort study. SETTING: Three teaching hospitals in the Netherlands. POPULATION: Women presenting with postmenopausal bleeding with an indication for endometrial sampling. METHODS: Multivariable logistic regression was performed to evaluate the impact of doctor's training level and patient's characteristics on failure of sampling. MAIN OUTCOME MEASURES: Failure of endometrial sampling, classified as technical failure or insufficient tissue for diagnosis. RESULTS: In 74 (20.8%) of the 356 included women, sampling technically failed, and in 84 (29.8%) the amount of tissue was insufficient for diagnosis. Nulliparity [odds ratio (OR) 3.8, 95% confidence interval (CI) 1.8-7.9] and advanced age (OR 1.03 per year, 95% CI 1.00-1.06) were associated with technical failure. Advanced age was associated with insufficient sampling (OR 1.04 per year, 95% CI 1.01-1.07), and endometrial thickness >12 mm decreased the chance of insufficient sampling (OR 0.3, 95%CI 0.1-0.8). The prediction model for total failure had an area under the ROC curve of 0.64 (95% CI 0.58-0.70). CONCLUSIONS: In women with postmenopausal bleeding, the failure rate of endometrial sampling is relatively high and is associated with nulliparity and advanced age. Endometrial thickness >12 mm decreased the chance of failure. A multivariable prediction model for total failure based on patient characteristics has a moderate capacity to discriminate between women at high or low risk of failure.

Levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation (Novasure) in women with heavy menstrual bleeding: a multicentre randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities. METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate. DISCUSSON: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding. TRIAL REGISTRATION: Dutch trial register, number NTR2984.

Hysteroscopic sterilization using a virtual reality simulator: assessment of learning curve.

STUDY OBJECTIVE: To assess the learning curve using a virtual reality simulator for hysteroscopic sterilization with the Essure method. DESIGN: Prospective multicenter study (Canadian Task Force classification II-2). SETTING: University and teaching hospital in the Netherlands. PARTICIPANTS: Thirty novices (medical students) and five experts (gynecologists who had performed >150 Essure sterilization procedures). INTERVENTIONS: All participants performed nine repetitions of bilateral Essure placement on the simulator. Novices returned after 2 weeks and performed a second series of five repetitions to assess retention of skills. Structured observations on performance using the Global Rating Scale and parameters derived from the simulator provided measurements for analysis. MEASUREMENTS AND MAIN RESULTS: The learning curve is represented by improvement per procedure. Two-way repeated-measures analysis of variance was used to analyze learning curves. Effect size (ES) was calculated to express the practical significance of the results (ES ≥ 0.50 indicates a large learning effect). For all parameters, significant improvements were found in novice performance within nine repetitions. Large learning effects were established for six of eight parameters (p < .001; ES, 0.50-0.96). Novices approached expert level within 9 to 14 repetitions. CONCLUSION: The learning curve established in this study endorses future implementation of the simulator in curricula on hysteroscopic skill acquisition for clinicians who are interested in learning this sterilization technique.

Essure removal surgery: Are preoperative transvaginal ultrasound and pelvic X-ray necessary?

OBJECTIVE: The objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity. STUDY DESIGN: Retrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included. Four experts first predicted hysteroscopy necessity based on transvaginal ultrasound description and secondly based on transvaginal ultrasound combined with the preoperative pelvic radiograph. Sensitivity, specificity, positive predictive value and negative predictive value of the predictive tests were calculated. RESULTS: Based on transvaginal ultrasound, the mean predictive characteristics for experts were: sensitivity 89.7% (range 66.7%-100%), specificity 37.4% (range 17.6%-67.7%), positive predictive value 18.8% (range 13.2%-29.5%) and negative predictive value 95.1% (range 86.1%-100%). After adding the pelvic radiograph to the transvaginal ultrasound descriptions, the results were: sensitivity 66.7% (range 53.3%-80%), specificity 72.6% (range 56%-97.3%), positive predictive value 23% (range 14.3%-26.9%) and negative predictive value 94.1 % (range 90.3%-98.4%). For three experts sensitivity decreased after adding the pelvic radiograph. For all experts specificity increased. CONCLUSION: It is difficult to preoperatively decide if the fourth marker of the Essure outer coil can be excised during hysteroscopy. The addition of pelvic radiography to transvaginal ultrasound is not beneficial. It is recommended to perform a hysteroscopy during Essure removal surgery.

Is 2-dimensional transvaginal ultrasonography necessary 6 weeks after insertion of the levonorgestrel 52-mg intrauterine device?

BACKGROUND: In Dutch practice, gynecologists are used to assessing the position of the LNG-IUD by performing a two-dimensional transvaginal ultrasonography (TVUS) directly after insertion and do not routinely invite patients for another consultation 4-12 weeks after insertion. There is no consensus whether a TVUS six weeks after insertion is routinely needed. OBJECTIVE: This study aimed to assess the incidence of malposition using 2-dimensional transvaginal ultrasonography during routine investigation 6 weeks after insertion. In addition, we investigated the relationship between malposition of the levonorgestrel 52-mg intrauterine device and unfavorable bleeding patterns and pelvic pain. STUDY DESIGN: We performed a large prospective cohort study. Patients seeking a levonorgestrel 52-mg intrauterine device were eligible for inclusion. Transvaginal ultrasonography was performed to check position of the levonorgestrel 52-mg intrauterine device immediately after insertion and 6 weeks later. Patients filled in questionnaires about bleeding pattern and pelvic pain 6 weeks after insertion. RESULTS: From March 2015 to December 2016, we enrolled 500 patients. Data from the transvaginal ultrasonography assessment 6 weeks after insertion were available for 448 patients, and complete data (transvaginal ultrasonography and questionnaire data) were available for 363 patients (72.6%). Malposition rate was 6.3% (28/448 patients). Malposition was seen in 15 of 198 patients (7.6%) with unfavorable bleeding and/or pelvic pain and in 3 of 165 patients (1.8%) with favorable bleeding patterns and no pelvic pain (P=.03).Malposition was seen in 14 of 186 patients (7.5%) with an unfavorable bleeding pattern and in 4 of 177 patients (2.3%) with favorable bleeding patterns (P=.008). Malposition was seen in 5 of 50 patients (10%) with pelvic pain and in 13 of 313 patients (4.2%) without pelvic pain (P=.08). CONCLUSION: The malposition rate of the levonorgestrel 52-mg intrauterine device observed using transvaginal ultrasonography 6 weeks after insertion was 6.3%. If patients have no complaints of unfavorable bleeding and/or pelvic pain, the risk for malposition is low (1.8%) and a routine transvaginal ultrasonography is not necessary. However, if patients experience unfavorable bleeding, a transvaginal ultrasonography should be considered to exclude malposition, because the effect of malposition on contraceptive effectiveness is unsure. Future research should focus on cost-benefit analysis.

Increased MR-guided high intensity focused ultrasound (MR-HIFU) sonication efficiency of uterine fibroids after carbetocin administration.

Purpose: We investigated whether administration of the long-acting uterus stimulant carbetocin increased intra-subject sonication efficiency during Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) treatment of uterine fibroids. Method: In this prospective cohort study, thirty women with symptomatic uterine fibroids undergoing MR-HIFU treatment were included between January 2018 and January 2019. Treatment started with three sonications on one side of the uterine fibroid. Subsequently, one ampoule of 1 mL carbetocin (100 µg/mL) was administered intravenously and treatment continued with three sonications on the other side of the uterine fibroid. We compared the intra-subject sonication efficiency, in terms of Energy Efficiency Factor (EEF), thermal dose volume and sonication time to ablate one cm3 of fibroid tissue, before and after carbetocin administration. Adverse events that occurred within 30 min after carbetocin administration were recorded. Results: Sonication efficiency improved after carbetocin administration as indicated by a significant decrease in EEF and sonication time (p = 0.006 and p = 0.001 respectively), and a significant increase in thermal dose volume reached (p = <0.001). Five women (16.7%) experienced temporary tachycardia, one women in combination with headache, within 30 min after carbetocin administration. Conclusion: Administration of the long-acting uterus stimulant carbetocin improved the MR-HIFU treatment intra-subject sonication efficiency in women with symptomatic uterine fibroids.

Confirmation of Essure placement using transvaginal ultrasound.

STUDY OBJECTIVE: To evaluate the protocol for confirmation of satisfactory Essure placement using transvaginal ultrasound. DESIGN: Prospective multicenter cohort study (Canadian Task Force classification II-2). SETTING: Outpatient departments of 4 teaching hospitals in the Netherlands. PATIENTS: Eleven hundred forty-five women who underwent hysteroscopic sterilization using the Essure device between March 2005 and December 2007. INTERVENTION: Transvaginal ultrasound examination 12 weeks after uncomplicated successful bilateral placement or as indicated according to the transvaginal ultrasound protocol after 4 weeks, and hysterosalpingography (HSG) at 12 weeks to confirm correct placement of the device after 3 months. MEASUREMENTS AND MAIN RESULTS: The rate of successful placement was 88.4% initially. In 164 women (15%), successful placement was confirmed at HSG according the protocol. In 9 patients (0.84%), incorrect position of the device was observed at HSG. The cumulative pregnancy rate after 18 months was 3.85 per thousand women. CONCLUSION: Transvaginal ultrasound should be the first diagnostic test used to confirm the adequacy of hysteroscopic Essure sterilization because it is minimally invasive, averts ionizing radiation, and does not decrease the effectiveness of the Essure procedure.

Live births after Asherman syndrome treatment.

OBJECTIVE: To study the reproductive outcomes after surgical management of women with Asherman syndrome (AS). DESIGN: Cohort study. SETTING: International referral hospital for women with AS. PATIENT(S): A total of 500 women who were diagnosed with and treated for AS between January 2003 and December 2016 and followed for a minimum of 2 years. INTERVENTION(S): Hysteroscopic adhesiolysis using conventional instruments with concomitant fluoroscopy as a guidance method. MAIN OUTCOME MEASURE(S): Live birth rate. RESULT(S): Of the 500 women included in the cohort, 569 pregnancies were achieved within 3 years after surgery. The miscarriage rate was 33.0%, and the live birth rate was 67.4%. Age, the causal procedure, and at least one miscarriage after adhesiolysis strongly predicted the outcome of a live birth. CONCLUSION(S): The overall take-home newborn rate was 67.4% after adhesiolysis in women with AS. Women with AS who are relatively young, with a first-trimester procedure preceding AS, and with low grades of adhesions and no miscarriage after adhesiolysis have the best chance of a newborn delivery.