Definition and sonographic reporting system for Cesarean scar pregnancy in early gestation: modified Delphi method.

OBJECTIVE: To develop a standardized sonographic evaluation and reporting system for Cesarean scar pregnancy (CSP) in the first trimester, for use by both general gynecology and expert clinics. METHODS: A modified Delphi procedure was carried out, in which 28 international experts in obstetric and gynecological ultrasonography were invited to participate. Extensive experience in the use of ultrasound to evaluate Cesarean section (CS) scars in early pregnancy and/or publications concerning CSP or niche evaluation was required to participate. Relevant items for the detection and evaluation of CSP were determined based on the results of a literature search. Consensus was predefined as a level of agreement of at least 70% for each item, and a minimum of three Delphi rounds were planned (two online questionnaires and one group meeting). RESULTS: Sixteen experts participated in the Delphi study and four Delphi rounds were performed. In total, 58 items were determined to be relevant. We differentiated between basic measurements to be performed in general practice and advanced measurements for expert centers or for research purposes. The panel also formulated advice on indications for referral to an expert clinic. Consensus was reached for all 58 items on the definition, terminology, relevant items for evaluation and reporting of CSP. It was recommended that the first CS scar evaluation to determine the location of the pregnancy should be performed at 6-7 weeks' gestation using transvaginal ultrasound. The use of magnetic resonance imaging was not considered to add value in the diagnosis of CSP. A CSP was defined as a pregnancy with implantation in, or in close contact with, the niche. The experts agreed that a CSP can occur only when a niche is present and not in relation to a healed CS scar. Relevant sonographic items to record included gestational sac (GS) size, vascularity, location in relation to the uterine vessels, thickness of the residual myometrium and location of the pregnancy in relation to the uterine cavity and serosa. According to its location, a CSP can be classified as: (1) CSP in which the largest part of the GS protrudes towards the uterine cavity; (2) CSP in which the largest part of the GS is embedded in the myometrium but does not cross the serosal contour; and (3) CSP in which the GS is partially located beyond the outer contour of the cervix or uterus. The type of CSP may change with advancing gestation. Future studies are needed to validate this reporting system and the value of the different CSP types. CONCLUSION: Consensus was achieved among experts regarding the sonographic evaluation and reporting of CSP in the first trimester. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure.

OBJECTIVE: To generate guidance for detailed uterine niche evaluation by ultrasonography in the non-pregnant woman, using a modified Delphi procedure amongst European experts. METHODS: Twenty gynecological experts were approached through their membership of the European Niche Taskforce. All experts were physicians with extensive experience in niche evaluation in clinical practice and/or authors of niche publications. By means of a modified Delphi procedure, relevant items for niche measurement were determined based on the results of a literature search and recommendations of a focus group of six Dutch experts. It was predetermined that at least three Delphi rounds would be performed (two online questionnaires completed by the expert panel and one group meeting). For it to be declared that consensus had been reached, a consensus rate for each item of at least 70% was predefined. RESULTS: Fifteen experts participated in the Delphi procedure. Consensus was reached for all 42 items on niche evaluation, including definitions, relevance, method of measurement and tips for visualization of the niche. A niche was defined as an indentation at the site of a Cesarean section with a depth of at least 2 mm. Basic measurements, including niche length and depth, residual and adjacent myometrial thickness in the sagittal plane, and niche width in the transverse plane, were considered to be essential. If present, branches should be reported and additional measurements should be made. The use of gel or saline contrast sonography was preferred over standard transvaginal sonography but was not considered mandatory if intrauterine fluid was present. Variation in pressure generated by the transvaginal probe can facilitate imaging, and Doppler imaging can be used to differentiate between a niche and other uterine abnormalities, but neither was considered mandatory. CONCLUSION: Consensus between niche experts was achieved regarding ultrasonographic niche evaluation. © 2018 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

3D power Doppler in uterine fibroids; influence of gain, cardiac cycle and off-line measurement techniques.

This study answers the question of whether ultrasound machine settings and the cardiac cycle can influence 3D power Doppler (3D PD) indices in the evaluation of uterine fibroid vascularisation. These parameters were reported to affect the vascular indices and cause undesired variation. 3D PD ultrasound was performed using three different gain settings: a fixed predetermined gain (50 dB), a higher gain (65 dB) and an individualised subjectively most optimal gain. Two consecutive 3D PD sweeps were taken to evaluate the effect of the cardiac cycle. A predetermined most optimal fixed gain setting was not different from the individually most optimal chosen gain in vascular assessment of fibroids. A higher gain corresponded with a significantly higher vascular index (VI). Potential variation during the cardiac cycle does not disturb the VI in fibroids.

Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development.

Caesarean section (CS) results in the occurrence of the phenomenon 'niche'. A 'niche' describes the presence of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a discontinuation of the myometrium at the site of a previous CS. Using gel or saline instillation sonohysterography, a niche is identified in the scar in more than half of the women who had had a CS, most with the uterus closed in one single layer, without closure of the peritoneum. An incompletely healed scar is a long-term complication of the CS and is associated with more gynaecological symptoms than is commonly acknowledged. Approximately 30% of women with a niche report spotting at 6-12 months after their CS. Other reported symptoms in women with a niche are dysmenorrhoea, chronic pelvic pain and dyspareunia. Given the association between a niche and gynaecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the aetiology of niche development after CS in order to develop preventive strategies. Based on current published data and our observations during sonographic, hysteroscopic and laparoscopic evaluations of niches we postulate some hypotheses on niche development. Possible factors that could play a role in niche development include a very low incision through cervical tissue, inadequate suturing technique during closure of the uterine scar, surgical interventions that increase adhesion formation or patient-related factors that impair wound healing or increase inflammation or adhesion formation.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review.

BACKGROUND: Various therapies are currently used to treat symptoms related to the niche (an anechoic area) in the caesarean scar, in particular to treat abnormal uterine bleeding (AUB). OBJECTIVE: To systematically review the available literature reporting on the effect of various therapies on niche-related symptoms. SEARCH STRATEGY: A systematic search of MEDLINE, Embase, Cochrane, trial registers and congress abstracts from AAGL and ESGE was performed. SELECTION CRITERIA: Articles reporting on the effectiveness of therapies other than hysterectomy in women with niche-related symptoms were included. Studies were included if they reported one of the following outcomes: effect on AUB, pain relief, sexual function, quality of life (QOL), and surgical, anatomic, fertility, or pregnancy outcome. DATA COLLECTION AND ANALYSIS: Two authors independently selected the articles to be included. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were followed. A standardised checklist was used to score the methodological quality of the included studies. MAIN RESULTS: Twelve studies were included, reporting on hysteroscopic niche resection (eight studies, 384 patients), laparoscopic repair (one study, 13 patients), (laparoscopic assisted) vaginal repair (two studies, 47 patients), and oral contraceptives (OCs) (one study, 11 patients). Reported AUB improved in the vast majority of the patients after these interventions, ranging from 87 to 100%. The rate of complications was low. Pregnancies were reported after therapy; however, sample sizes and follow-up were insufficient to study fertility or pregnancy outcome. The methodological quality of the selected papers was considered to be moderate to poor, and was therefore insufficient to make solid conclusions. AUTHOR'S CONCLUSIONS: More evidence is needed before (surgical) niche interventions are implemented in daily practice.

Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding.

OBJECTIVE: To study the prevalence of niches in the caesarean scar in a random population, and the relationship with postmenstrual spotting and urinary incontinence. DESIGN: A prospective cohort study. SETTING: A teaching hospital in the Netherlands. POPULATION: Non-pregnant women delivered by caesarean section. METHODS: Transvaginal ultrasound (TVU) and gel instillation sonohysterography (GIS) were performed 6-12 weeks after caesarean section. Women were followed by questionnaire and menstruation score chart at 6-12 weeks, 6 months, and 12 months after caesarean section. MAIN OUTCOME MEASURES: Prevalence of a niche 6-12 weeks after caesarean section, using TVU and GIS. SECONDARY OUTCOMES: relation to postmenstrual spotting and urinary incontinence 6 and 12 months after caesarean section; and niche characteristics, evaluated by TVU and GIS. RESULTS: Two hundred and sixty-three women were included. Niche prevalence was 49.6% on evaluation with TVU and 64.5% with GIS. Women with a niche measured by GIS reported more postmenstrual spotting than women without a niche (OR 5.48, 95% CI 1.14-26.48). Women with residual myometrium at the site of the uterine scar measuring <50% of the adjacent myometrial thickness had postmenstrual spotting more often than women with a residual myometrial thickness of >50% of the adjacent myometrial thickness (OR 6.13, 95% CI 1.74-21.63). Urinary incontinence was not related to the presence of a niche. CONCLUSIONS: A niche is present in 64.5% of women 6-12 weeks after caesarean section, when examined by GIS. Postmenstrual spotting is more prevalent in women with a niche and in women with a residual myometrial thickness of <50% of the adjacent myometrium.

Prediction of time to return to work after gynaecological surgery: a prospective cohort study in the Netherlands.

OBJECTIVE: To measure the impact of the level of invasiveness of gynaecological procedures on time to full Return to Work (RTW) and to identify the most important preoperative sociodemographic, medical and work-related factors that predict the risk of prolonged sick leave. DESIGN: Prospective cohort study. SETTING: Dutch university hospital. POPULATION: A total of 148 women aged 18-65 years scheduled for gynaecological surgery for benign indications. METHODS: A questionnaire regarding the surgical procedure as well as perioperative and postoperative complications was completed by the attending resident at baseline and 6 weeks after surgery. All other outcome measures were assessed using self-reported patient questionnaires at baseline and 12 weeks post-surgery. The follow-up period was extended up to 1 year after surgery in women failing to return to work. Surgical procedures were categorised into diagnostic, minor, intermediate and major surgery. MAIN OUTCOME MEASURES: Time to RTW and important predictors for prolonged sick leave after surgery. RESULTS: Median time to RTW was 7 days (interquartile range [IQR] 5-14) for diagnostic surgery, 14 days (IQR 9-28) for minor surgery, 60 days (IQR 28-101) for intermediate surgery and 69 days (IQR 56-135) for major surgery. Multivariable analysis showed a strongest predictive value of RTW 1 year after surgery for level of invasiveness of surgery (minor surgery hazard ratio [HR] 0.51, 95% CI 0.32-0.81; intermediate surgery HR 0.20, 95% CI 0.12-0.34; major surgery HR 0.09, 95% CI 0.06-0.16), RTW expectations before surgery (HR 0.55, 95% CI 0.36-0.84), and preoperative functional status (HR 1.09, 95% CI 1.04-1.13). A prediction model regarding the probability of prolonged sick leave at 6 weeks was developed, with a sensitivity of 89% and a specificity of 86%. CONCLUSIONS: RTW often takes a long time, especially after intermediate and major surgery. This study reveals important predictors for prolonged sick leave and provides a prediction model for the risk of sick leave extending 6 weeks after benign gynaecological surgery in the Netherlands.

A personalised eHealth programme reduces the duration until return to work after gynaecological surgery: results of a multicentre randomised trial.

OBJECTIVE: To evaluate the effectiveness of an eHealth intervention on recovery and return to work, after gynaecological surgery. DESIGN: Randomised multicentre trial that ran from March 2010 until September 2011. SETTING: Secondary care in seven general and university hospitals in The Netherlands. POPULATION: A cohort of 215 women (aged 18-65 years) who had a hysterectomy and/or laparoscopic adnexal surgery for a benign indication. METHODS: The women were randomly assigned to the intervention group (n = 110) or the control group (n = 105). The intervention group received an eHealth programme that provided personalised tailor-made pre- and postoperative instructions on the resumption of daily activities, including work, and tools to improve self-empowerment and to identify recovery problems. The control group was provided with access to a control website. MAIN OUTCOME MEASURES: The primary outcome was the duration of sick leave until a full sustainable return to work. Secondary outcome measures were quality of life, general recovery, and pain intensity. RESULTS: In intention-to-treat analysis the eHealth intervention was effective on time to return to work (hazard ratio 1.43; 95% confidence interval 1.003-2.040; P = 0.048). The median duration of sick leave until a full sustainable return to work was 39 days (interquartile range 20-67 days) in the intervention group and 48 days (interquartile range 21-69 days) in the control group. After 26 weeks pain intensity was lower (visual analogue scale, cumulative odds ratio 1.84; 95% confidence interval 1.04-3.25; P = 0.035) and quality of life was higher (Rand-36 health survey, between-group difference 30, 95% confidence interval 4-57; P = 0.024) in the intervention group, compared with the control group. CONCLUSIONS: The use of the eHealth intervention by women after gynaecological surgery results in a faster return to work, with a higher quality of life and less pain.

Real-time elastography for assessment of uterine disorders.

OBJECTIVES: Sonoelastography is an ultrasound-imaging technique that measures tissue strain. The aim of this study was to define, in a systematic manner, specific sonoelastographic characteristics of the myometrium, fibroids and adenomyosis, to evaluate the feasibility of sonoelastography in patients with suspected gynecological pathology and to compare the results with histology and/or magnetic resonance imaging (MRI)-based diagnoses. METHODS: We performed a prospective observational cohort study between 2009 and 2011. Two-hundred and eighteen women with suspected gynecological pathology underwent routine transvaginal ultrasound and additional real-time sonographic elastography. Sixty-nine of the 218 women underwent MRI and/or histological examination and were included in the final analysis. Acquisition of elastographic images was standardized. We analyzed the elastographic characteristics of myometrium, fibroids and adenomyosis. An independent observer, unaware of clinical, histological or MRI findings, evaluated the recorded elastographic images and cineloops. These elastographic-based diagnoses were compared with histology and/or MRI diagnoses. RESULTS: With elastography, the uterus was well delineated from the surrounding bowel. The myometrium was uniform in color in 49% of the cases, with a main color of purple or dark blue, indicating stiffer tissue. Fibroids and adenomyosis had different elastographic characteristics and different color patterns. In general, fibroids were darker and adenomyosis was brighter than adjacent myometrium. The agreement between elastography-based diagnosis of fibroids and adenomyosis with MRI-based diagnosis was excellent; with histology-based diagnosis, agreement was substantial for fibroids and adenomyosis. CONCLUSIONS: Elastography is able to identify clear discriminating characteristics of the uterus, fibroids and adenomyosis, and elastography-based diagnoses are in excellent agreement with those of MRI. Agreement between elastography-based diagnosis of adenomyosis and histology is substantial but not optimal.