Structured hysteroscopic examination of uterine niches: a modified Delphi procedure.

Background: Uterine niches in the Caesarean section scar are seen in approximately half of women with a history of caesarean delivery. Whilst a structured ultrasound assessment of caesarean defects has been described, there is no consensus on a structured hysteroscopic evaluation. Objectives: To propose a methodology for a structured hysteroscopic evaluation of uterine niches. Materials and Methods: We conducted a modified Delphi procedure, including two online rounds and two face-to-face meetings of the members of the ESGE Uterine Niches Working Group. The taskforce members have extensive experience in hysteroscopic niche evaluation. The consensus was predefined as a Rate of Agreement of at least 75%. Results: Thirteen experts participated in this modified Delphi procedure. There was consensus on the need for a standardised methodology and the hysteroscopic definition of a niche as any indentation in the myometrium at the site of a previous CS. There was consensus that a hysteroscopic evaluation of a niche must be combined with ultrasound to measure the residual myometrial thickness. In addition, it was agreed that niches should be subclassified as 'simple', 'simple with one branch', or 'complex'. There was consensus that the following items should be described during a hysteroscopic niche evaluation: the number of niches, the size in relation to the size of cervical canal, the presence of polyps, crypts, cysts, fibrotic tissue, blood, mucus, placental remnants, a dynamic valve, the appearance of the endometrium, the number of blood vessels and bleeding from blood vessels within the defect. Conclusion: Using a modified Delphi procedure with international experts, consensus was achieved on the hysteroscopic evaluation and classification of niches in the uterine caesarean section scar. What is new?: A structured registration form was developed to aid consistency in hysteroscopic niche reporting.

Evaluating use of IOTA two-step strategy to classify adnexal masses identified in pregnancy: pilot study.

OBJECTIVES: The primary aim was the validation of benign descriptors (BDs), followed by Assessment of Different NEoplasia's of the adneXa (ADNEX) (when BDs cannot be applied), in a two-step strategy to classify adnexal masses in pregnancy. The secondary aim was to describe the natural history of adnexal masses in pregnancy. METHODS: Retrospective analysis of prospectively collected data of women with an adnexal mass on ultrasonography identified during pregnancy between 2017 and 2022. The study was conducted at Queen Charlotte's and Chelsea Hospital, UK. Relevant clinical and ultrasound data were extracted from the medical records and ultrasound software astraia. Adnexal masses were classified and managed according to expert subjective assessment (SA). Ultrasound features were recorded prospectively at the time of ultrasound examination. Borderline ovarian tumours (BOT) were classified as malignant. Benign Descriptors (BDs) were applied to classify adnexal masses, in cases where BDs were not applicable, the ADNEX model (using a risk of malignancy of >10%) was used, in a two-step strategy. The two-step strategy was applied retrospectively. The reference standard used was histology (where available) or expert SA at the postnatal ultrasound scan. RESULTS: 291 women with a median age of 33 (IQR 29-36) years presented with an adnexal mass in pregnancy, at a median gestation of 12 (IQR 8-17) weeks. 267 (267/291, 91.8%) women were followed up to the postnatal period, as 24 women (24/291, 8.2%) were lost to follow up. Based on the reference standard, 4.1% of adnexal masses (11/267) were classified as malignant (all BOTs) and 95.9% (256/267) as benign (41 on histology and 215 based on expert SA at postnatal ultrasound). BDs could be applied to 68.9% of adnexal masses (184/267); of these only one mass (BOT) was misclassified as benign (1/184, 0.5%). ADNEX was used to classify the residual masses (83/267) and misclassified three BOTs as benign (3/10, 30.0%) and 25 benign masses (based on reference standard) as malignant (25/73, 34.2%), 13 (13/25, 52.0%) of these were classified as decidualised endometriomas on expert SA, with confirmed resolution of decidualisation in the postnatal period. The two-step strategy had a specificity of 90.2%, sensitivity of 63.6%, negative predictive value of 98.3% and positive predictive value of 21.9%. 56 (56/267, 21.0%) women had surgical intervention, four as an emergency during pregnancy (4/267, 1.5%,) and four (4/267, 1.5%) electively during caesarean section. 48 (48/267, 18.0%) women had surgical intervention in the post-natal period, 11 (11/267, 4.1%) in the first 12 weeks postnatal and 37 >12 weeks (37/267, 13.9%) postnatal. 64 (64/267, 24.0%) adnexal masses resolved spontaneously during follow up. Cyst-related complications occurred in four women (4/267, 1.5%) during pregnancy (ovarian torsion n=2, cyst rupture n=2) and six (6/267, 2.2%) in the postnatal period (all ovarian torsion). 196 (196/267, 73.4%) had a persistent adnexal mass, including one of the women who had an ovarian torsion and underwent de-torsion and had a persistent adnexal mass at postnatal ultrasound. Presumed decidualisation occurred in 31.1% (19/61) of endometriomas and had resolved in 89.5% (17/19) by the first postnatal ultrasound scan. CONCLUSION: We found Benign Descriptors apply to most masses in pregnancy, however the small number of malignant tumours in the cohort (4.1%) restricted the evaluation of the ADNEX model, so expert subjective assessment should be used to classify adnexal masses in pregnancy, when BDs do not apply. A larger multicentre prospective study is required to evaluate the use of the ADNEX model to classify adnexal masses in pregnancy. Our data suggests that most adnexal masses can be managed expectantly during pregnancy given a large proportion of masses spontaneously resolved and the low risk of complications. This article is protected by copyright. All rights reserved.

Validation of ADNEX and IOTA two-step strategy and estimation of risk of complications during follow-up of adnexal masses in low-risk population.

OBJECTIVES: To evaluate the ability of the Assessment of Different NEoplasias in the adneXa (ADNEX) model and the International Ovarian Tumour Analysis (IOTA) two-step strategy to predict malignancy in adnexal masses detected in an outpatient low-risk setting, and to estimate the risk of complications in masses with benign ultrasound morphology managed using clinical and ultrasound follow-up. METHODS: This single-center study was performed at Hospital Universitari Dexeus, Barcelona, Spain, using interim data from the ongoing prospective observational IOTA Phase-5 (IOTA5) study. The primary aim of the IOTA5 study is to describe the cumulative incidence of complications during follow-up of adnexal masses classified as benign on ultrasound examination. Consecutive patients with an adnexal mass detected between June 2012 and September 2016 in a private center offering screening for gynecological cancer were included and followed up until February 2020. Tumors were classified as benign or malignant based on histology (if patients underwent surgery) or the outcome of clinical and ultrasound follow-up at 12 (range, 10-14) months. Multiple imputation was used when outcomes were uncertain. The ability of the ADNEX model without CA125 and of the IOTA two-step strategy to distinguish benign from malignant masses was evaluated retrospectively using the prospectively collected data. We assessed performance with regard to discrimination (area under the receiver-operating-characteristics curve (AUC)), calibration, classification (sensitivity and specificity) and clinical utility (Net Benefit). In the group of patients with a mass judged to be benign who were selected for conservative management, we evaluated the occurrence of spontaneous resolution or any mass complication during the first 5 years of follow-up by assessing the cumulative incidence of malignancy, torsion, cyst rupture and minor mass complications (inflammation, infection or adhesions) and the time to occurrence of an event. RESULTS: A total of 2654 patients were recruited to the study. After application of exclusion criteria, 2039 patients with a newly detected mass were included for the model validation. Of those, 1684 (83%) masses were benign, 49 (2%) masses were malignant and, for 306 (15%) masses, the outcome was uncertain and therefore imputed. The AUC was 0.95 (95% CI, 0.89-0.98) for ADNEX without CA125 and 0.94 (95% CI, 0.88-0.97) for the two-step strategy. Calibration performance could not be meaningfully interpreted because the small number of malignancies resulted in very wide confidence intervals. The two-step strategy had better clinical utility than did the ADNEX model at malignancy risk thresholds < 3%. There were 1472 (72%) patients whose mass was judged to be benign based on pattern recognition by an experienced ultrasound examiner and were managed with clinical and ultrasound follow-up. In this group, the 5-year cumulative incidence was 66% (95% CI, 63-69%) for spontaneous resolution of the mass, 0% (95% CI, 0-0.2%) for torsion, 0.1% (95% CI, < 0.1-0.4%) for cyst rupture, 0.2% (95% CI, 0.1-0.6%) for a borderline tumor and 0.2% (95% CI, 0.1-0.6%) for invasive malignancy. CONCLUSIONS: The ADNEX model and IOTA two-step strategy performed well to distinguish benign from malignant adnexal masses detected in a low-risk population. Conservative management is safe for masses with a benign ultrasound appearance in this population. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

How to perform standardized sonographic examination of Cesarean scar pregnancy in the first trimester.

Early diagnosis and appropriate management of Cesarean scar pregnancy (CSP) are crucial to prevent severe complications, such as uterine rupture, severe hemorrhage and placenta accreta spectrum disorders. In this article, we provide a step-by-step tutorial for the standardized sonographic evaluation of CSP in the first trimester. Practical steps for performing a standardized transvaginal ultrasound examination to diagnose CSP are outlined, focusing on criteria and techniques essential for accurate identification and classification. Key sonographic markers, including gestational sac location, cardiac activity, placental implantation and myometrial thickness, are detailed. The evaluation process is presented according to assessment of the uterine scar, differential diagnosis, detailed CSP evaluation and CSP classification. This step-by-step tutorial emphasizes the importance of scanning in two planes (sagittal and transverse), utilizing color or power Doppler and differentiating CSP from other low-lying pregnancies. The CSP classification is described in detail and is based on the location of the largest part of the gestational sac relative to the uterine cavity and serosal lines. This descriptive classification is recommended for clinical use to stimulate uniform description and evaluation. Such a standardized sonographic evaluation of CSP in the first trimester is essential for early diagnosis and management, helping to prevent life-threatening complications and to preserve fertility. Training sonographers in detailed evaluation techniques and promoting awareness of CSP are critical. The structured approach to CSP diagnosis presented herein is supported by a free e-learning course available online. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Updating M6 pregnancy of unknown location risk-prediction model including evaluation of clinical factors.

OBJECTIVES: Ectopic pregnancy (EP) is a major high-risk outcome following a pregnancy of unknown location (PUL) classification. Biochemical markers are used to triage PUL as high vs low risk to guide appropriate follow-up. The M6 model is currently the best risk-prediction model. We aimed to update the M6 model and evaluate whether performance can be improved by including clinical factors. METHODS: This prospective cohort study recruited consecutive PUL between January 2015 and January 2017 at eight units (Phase 1), with two centers continuing recruitment between January 2017 and March 2021 (Phase 2). Serum samples were collected routinely and sent for ß-human chorionic gonadotropin (ß-hCG) and progesterone measurement. Clinical factors recorded were maternal age, pain score, bleeding score and history of EP. Based on transvaginal ultrasonography and/or biochemical confirmation during follow-up, PUL were classified subsequently as failed PUL (FPUL), intrauterine pregnancy (IUP) or EP (including persistent PUL (PPUL)). The M6 models with (M6P ) and without (M6NP ) progesterone were refitted and extended with clinical factors. Model validation was performed using internal-external cross-validation (IECV) (Phase 1) and temporal external validation (EV) (Phase 2). Missing values were handled using multiple imputation. RESULTS: Overall, 5473 PUL were recruited over both phases. A total of 709 PUL were excluded because maternal age was < 16 years or initial ß-hCG was ≤ 25 IU/L, leaving 4764 (87%) PUL for analysis (2894 in Phase 1 and 1870 in Phase 2). For the refitted M6P model, the area under the receiver-operating-characteristics curve (AUC) for EP/PPUL vs IUP/FPUL was 0.89 for IECV and 0.84-0.88 for EV, with respective sensitivities of 94% and 92-93%. For the refitted M6NP model, the AUCs were 0.85 for IECV and 0.82-0.86 for EV, with respective sensitivities of 92% and 93-94%. Calibration performance was good overall, but with heterogeneity between centers. Net Benefit confirmed clinical utility. The change in AUC when M6P was extended to include maternal age, bleeding score and history of EP was between -0.02 and 0.01, depending on center and phase. The corresponding change in AUC when M6NP was extended was between -0.01 and 0.03. At the 5% threshold to define high risk of EP/PPUL, extending M6P altered sensitivity by -0.02 to -0.01, specificity by 0.03 to 0.04 and Net Benefit by -0.005 to 0.006. Extending M6NP altered sensitivity by -0.03 to -0.01, specificity by 0.05 to 0.07 and Net Benefit by -0.005 to 0.006. CONCLUSIONS: The updated M6 model offers accurate diagnostic performance, with excellent sensitivity for EP. Adding clinical factors to the model improved performance in some centers, especially when progesterone levels were not suitable or unavailable. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Estimating risk of endometrial malignancy and other intracavitary uterine pathology in women without abnormal uterine bleeding using IETA-1 multinomial regression model: validation study.

OBJECTIVES: To assess the ability of the International Endometrial Tumor Analysis (IETA)-1 polynomial regression model to estimate the risk of endometrial cancer (EC) and other intracavitary uterine pathology in women without abnormal uterine bleeding. METHODS: This was a retrospective study, in which we validated the IETA-1 model on the IETA-3 study cohort (n = 1745). The IETA-3 study is a prospective observational multicenter study. It includes women without vaginal bleeding who underwent a standardized transvaginal ultrasound examination in one of seven ultrasound centers between January 2011 and December 2018. The ultrasonography was performed either as part of a routine gynecological examination, during follow-up of non-endometrial pathology, in the work-up before fertility treatment or before treatment for uterine prolapse or ovarian pathology. Ultrasonographic findings were described using IETA terminology and were compared with histology, or with results of clinical and ultrasound follow-up of at least 1 year if endometrial sampling was not performed. The IETA-1 model, which was created using data from patients with abnormal uterine bleeding, predicts four histological outcomes: (1) EC or endometrial intraepithelial neoplasia (EIN); (2) endometrial polyp or intracavitary myoma; (3) proliferative or secretory endometrium, endometritis, or endometrial hyperplasia without atypia; and (4) endometrial atrophy. The predictors in the model are age, body mass index and seven ultrasound variables (visibility of the endometrium, endometrial thickness, color score, cysts in the endometrium, non-uniform echogenicity of the endometrium, presence of a bright edge, presence of a single dominant vessel). We analyzed the discriminative ability of the model (area under the receiver-operating-characteristics curve (AUC); polytomous discrimination index (PDI)) and evaluated calibration of its risk estimates (observed/expected ratio). RESULTS: The median age of the women in the IETA-3 cohort was 51 (range, 20-85) years and 51% (887/1745) of the women were postmenopausal. Histology showed EC or EIN in 29 (2%) women, endometrial polyps or intracavitary myomas in 1094 (63%), proliferative or secretory endometrium, endometritis, or hyperplasia without atypia in 144 (8%) and endometrial atrophy in 265 (15%) women. The endometrial sample had insufficient material in five (0.3%) cases. In 208 (12%) women who did not undergo endometrial sampling but were followed up for at least 1 year without clinical or ultrasound signs of endometrial malignancy, the outcome was classified as benign. The IETA-1 model had an AUC of 0.81 (95% CI, 0.73-0.89, n = 1745) for discrimination between malignant (EC or EIN) and benign endometrium, and the observed/expected ratio for EC or EIN was 0.51 (95% CI, 0.32-0.82). The model was able to categorize the four histological outcomes with considerable accuracy: the PDI of the model was 0.68 (95% CI, 0.62-0.73) (n = 1532). The IETA-1 model discriminated very well between endometrial atrophy and all other intracavitary uterine conditions, with an AUC of 0.96 (95% CI, 0.95-0.98). Including only patients in whom the endometrium was measurable (n = 1689), the model's AUC was 0.83 (95% CI, 0.75-0.91), compared with 0.62 (95% CI, 0.52-0.73) when using endometrial thickness alone to predict malignancy (difference in AUC, 0.21; 95% CI, 0.08-0.32). In postmenopausal women with measurable endometrial thickness (n = 848), the IETA-1 model gave an AUC of 0.81 (95% CI, 0.71-0.91), while endometrial thickness alone gave an AUC of 0.70 (95% CI, 0.60-0.81) (difference in AUC, 0.11; 95% CI, 0.01-0.20). CONCLUSION: The IETA-1 model discriminates well between benign and malignant conditions in the uterine cavity in patients without abnormal bleeding, but it overestimates the risk of malignancy. It also discriminates well between the four histological outcome categories. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

Addendum to the consensus opinion from the International Deep Endometriosis Analysis (IDEA) group: sonographic evaluation of the parametrium.

Preoperative sonographic staging in patients with suspected parametrial endometriosis is essential to plan the surgical intervention and to anticipate the need for a multidisciplinary approach, and hence optimize surgical outcome. The results of a recent metanalysis suggest that defining more accurately the ultrasonographic criteria of parametrial involvement in endometriosis is needed. The aim of this addendum to the IDEA-consensus is to highlight the sonographic characteristics of the parametrium and identify ultrasound techniques to diagnose deep endometriosis in this area. This article is protected by copyright. All rights reserved.

Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial.

OBJECTIVE: To investigate whether psychological wellbeing of women with an intrauterine pregnancy of uncertain viability can be modified during the waiting period to final diagnosis, by offering predictive information regarding the likely outcome of the pregnancy (chance of ongoing viability). METHODS: This was a single-center two-arm randomized controlled trial conducted over 18 months at a teaching hospital in London, UK. Consecutive eligible women attending the early pregnancy assessment unit with an interim ultrasound finding of intrauterine pregnancy of uncertain viability were recruited. All women were offered a follow-up ultrasound scan after 14 days. Participants were randomized to receive a prediction score for ongoing viability at 14 days or routine care (control). Anxiety, depression and worry symptoms were assessed using validated self-report questionnaires (hospital anxiety and depression scale (HADS), Penn state worry questionnaire (PSWQ)) prior to randomization and at two further timepoints during the waiting period preceding final diagnosis. The change in psychological scores over the study period was analyzed. The secondary outcome was the perceived value of the risk prediction tool reported by participants. RESULTS: A total of 278 women participated in this study. After adjusting for baseline scores, no difference in anxiety, depression or worry scores was demonstrated between control and intervention groups at either timepoint. Subgroup analysis, first of women with high initial anxiety (HADS > 11) or worry (PSWQ ≥ 45), and second of women with a more favorable predicted prognosis (≥ 75% chance of ongoing viability), demonstrated no difference between intervention and control groups. Despite this, 76/110 (69.1% (95% CI, 60.5-78.4%)) women who provided feedback in the intervention group found it to be helpful and 97/110 (88.2% (95% CI, 81.0-93.7%)) reported that they would use the tool again. CONCLUSION: Current prediction tools may be useful for healthcare professionals to guide management and optimize utilization of early pregnancy resources. However, in this study, implementation of an accurate tool did not result in an objective measurable benefit to patients in terms of reduction in anxiety, depression and worry symptoms experienced during the waiting period to final outcome compared with women who did not receive a prediction score. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors: retrospective validation in IOTA5 multicenter cohort.

OBJECTIVE: Previous work has suggested that the ultrasound-based benign simple descriptors (BDs) can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. This study aimed to validate a modified version of the BDs and to validate a two-step strategy to estimate the risk of malignancy, in which the modified BDs are followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model if modified BDs do not apply. METHODS: This was a retrospective analysis using data from the 2-year interim analysis of the International Ovarian Tumor Analysis (IOTA) Phase-5 study, in which consecutive patients with at least one adnexal mass were recruited irrespective of subsequent management (conservative or surgery). The main outcome was classification of tumors as benign or malignant, based on histology or on clinical and ultrasound information during 1 year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. RESULTS: A total of 8519 patients were recruited at 36 centers between 2012 and 2015. We excluded patients who were already in follow-up at recruitment and all patients from 19 centers that did not fulfil our criteria for good-quality surgical and follow-up data, leaving 4905 patients across 17 centers for statistical analysis. Overall, 3441 (70%) tumors were benign, 978 (20%) malignant and 486 (10%) uncertain. The modified BDs were applicable in 1798/4905 (37%) tumors, of which 1786 (99.3%) were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver-operating-characteristics curve (AUC) of 0.94 (95% CI, 0.92-0.96). The risk of malignancy was slightly underestimated, but calibration varied between centers. A sensitivity analysis in which we expanded the definition of uncertain outcome resulted in 1419 (29%) tumors with uncertain outcome and an AUC of the two-step strategy without CA125 of 0.93 (95% CI, 0.91-0.95). CONCLUSION: A large proportion of adnexal masses can be classified as benign by the modified BDs. For the remaining masses, the ADNEX model can be used to estimate the risk of malignancy. This two-step strategy is convenient for clinical use. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study.

OBJECTIVE: To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection. METHODS: Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant. RESULTS: Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3-1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2. CONCLUSIONS: Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians' threshold for delivery should be low if there are concerns with fetal movements or fetal heart rate monitoring in the time around infection. The proportion affected by pre-eclampsia amongst participants was not higher than would be expected, although we report a higher than expected proportion affected by eclampsia. There appears to be no effect on birthweight or congenital malformations in women affected by SARS-CoV-2 infection in pregnancy and neonatal infection is uncommon. This study reflects a population with a range of infection severity for SARS-COV-2 in pregnancy, generalisable to whole obstetric populations.