Reproductive outcomes after laparoscopic resection of symptomatic niches in uterine cesarean scars: Long-term follow-up on the prospective LAPNICHE study.

INTRODUCTION: After incomplete healing of the uterine cesarean section scar, a niche can be observed; 24% of the women develop large niches with a residual myometrial thickness <3 mm. In these cases a laparoscopic resection is possible. The effect of this new treatment on fertility outcome is not known yet. This paper describes reproductive outcomes 2 years after a laparoscopic niche resection and compares women with or without secondary infertility at baseline. MATERIAL AND METHODS: A prospective cohort study was performed, with consecutive inclusion of women between 2011 and 2019. Women with a niche in the uterine cesarean scar, with a residual myometrial thickness of <3 mm and with a desire to become pregnant, were scheduled to undergo a laparoscopic niche resection because of one or more of the following problems (1) postmenstrual spotting; (2) midcycle intrauterine fluid accumulation diagnosed during the fertility workup or (3) difficulties with a previous embryo transfer and preferring a surgical therapy. The study is registered in the ISRCTN register (ref. no. ISRCTN02271575) on April 23, 2013. RESULTS: There were 133 (62%) women included with a desire to become pregnant, 88 with secondary infertility. In all, 83 had an ongoing pregnancy at the 2-year follow-up. The ongoing pregnancy rate in patients with previous fertility problems was 60.2% compared with 66.7% in patients without infertility (odds ratio [OR] 0.68, 95% confidence interval [CI] 0.32-1.7). The OR for live births was 0.57 (95% CI 0.02-1.2). Overall, 8.3% of the pregnancies resulted in miscarriages by the 2-year follow-up. CONCLUSIONS: The reproductive outcomes in women with and without previous fertility problems undergoing resection of a large niche are very promising and quite comparable in both groups. These results suggest, but do not prove, a beneficial effect of this therapy for these indications. The results support the design of future randomized controlled trials to evaluate the effect of niche resection vs expectant management to assess its additional value in women with or without fertility problems who desire pregnancy.

The link between intrauterine adhesions and impaired reproductive performance: a systematic review of the literature.

BACKGROUND: Intrauterine adhesions (IUAs) are one of the main reproductive system diseases in women worldwide. Fusion between the injured opposing walls leads to partial-to-complete obliteration of the cavity and/or cervical canal. The main clinical manifestations in case of IUAs are menstrual disturbances, cyclic pain and reproductive disorders. The reproductive outcomes of women with IUAs remain limited and inefficient compared to women without IUAs, even after adhesiolysis. An exact understanding of the underlying mechanisms and processes to explain the compromised reproductive performance and outcomes in case of IUAs are lacking. METHODS: A systematic literature review of MEDLINE-PubMed (1966 to January 2022) and EMBASE (1974 to January 2022) was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported underlying causes, related mechanisms and processes to explain the association between IUAs and impaired reproductive performance, pregnancy and obstetric complications. RESULTS: After an extensive review of the literature, 58 articles were identified reporting underlying mechanisms to explain the association between IUAs and impaired fertility. Intrauterine scarring influences the process of fertilization, reproductive performance and ultimately reproductive outcome. IUAs can disturb the cervico-utero-tubal sperm transport and result in an avascular and unresponsive endometrium with decreased receptivity and thickness. Abnormal decidualization and abnormal trophoblastic infiltration leads to placental attachment disorders. Moreover, the risk for premature delivery, intrauterine fetal growth restriction and fetal anomalies is increased in case of IUAs. CONCLUSION: The impact of IUAs on reproductive performance, even after adhesiolysis, is becoming more apparent. The postulated mechanisms to explain the association are related to sperm transport, embryo implantation and placentation. Prevention, by preserving the basal layer of the endometrium is essential. Effective and evidence-based strategies for the prevention of endometrial injury and formation of IUAs, are urgently needed.

Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial.

STUDY QUESTION: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. SUMMARY ANSWER: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth. WHAT IS KNOWN ALREADY: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. STUDY DESIGN, SIZE, DURATION: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. PARTICIPANTS/MATERIALS, SETTING, METHODS: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. MAIN RESULTS AND THE ROLE OF CHANCE: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. LIMITATIONS, REASONS FOR CAUTION: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage. WIDER IMPLICATIONS OF THE FINDINGS: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. STUDY FUNDING/COMPETING INTEREST(S): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR 3120.

Electronic Continuous Pain Measurement vs Verbal Rating Scale in gynaecology: A prospective cohort study.

OBJECTIVE: To compare pain measured with a new electronic device - the Continuous Pain Score Meter (CPSM) - and the Verbal Rating Scale (VRS) during gynaecological procedures in an outpatient setting, and to correlate these outcomes with baseline anxiety and patient (in)tolerance to the procedure. STUDY DESIGN: This prospective cohort study was undertaken in two centres: a university hospital and a large teaching hospital in The Netherlands. Patients undergoing an outpatient hysteroscopy, colposcopy or ovum pick-up procedure for in-vitro fertilization in one of the two participating hospitals with availability of the CPSM were included. Pain was measured by both the CPSM and the VRS. Patient tolerance to the procedure was reported. Various outcomes of the CPSM were compared with those of the VRS and related to baseline anxiety scores. RESULTS: Ninety-one of 108 included patients (84 %) used the CPSM correctly during the procedure, and it was possible to analyse the CPSM scores for 87 women (81 %). The CPSM scores were all linearly related to the VRS. The peak pain score on the CPSM (CPSM-PPS) had the strongest correlation with the VRS score for all three procedures. Higher CPSM-PPS was related to patient (in)tolerance to the procedure (p = 0.03-0.002). Anxiety at baseline was not correlated with pain perception, except for VRS during colposcopy (r = 0.39, p = 0.016). CONCLUSION: The majority of patients were able to use the CPSM correctly, resulting in detailed information on pain perception for each individual pain stimulus during three outpatient gynaecological procedures. The CPSM-PPS had the strongest correlation with the VRS score and patient (in)tolerance to the procedure.

Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.

OBJECTIVE: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. DESIGN: Follow-up of a prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. INTERVENTION(S): Participants received a questionnaire 30 months after treatment. MAIN OUTCOME MEASURE(S): Ongoing pregnancy and outcome of subsequent pregnancies. RESULT(S): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. CONCLUSION(S): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. DUTCH CLINICAL TRIAL REGISTRY NUMBER: NTR 3120.

Reproductive performance after the application of hyaluronic acid gel after dilation and curettage in women who have experienced at least one previous curettage: long-term results of a multicenter prospective randomized trial.

OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance. DESIGN: Multicenter prospective randomized trial. SETTING: One university and seven university-affiliated teaching hospitals. PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed. INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome. MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively. CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Accuracy and Reproducibility of Sonoelastography for the Assessment of Fibroids and Adenomyosis, with Magnetic Resonance Imaging as Reference Standard.

The aims of this prospective diagnostic evaluation study were (i) to estimate the inter-observer agreement and reproducibility of real-time sonoelastography and real-time gray-scale ultrasound in the measurement of uterine and fibroid volumes; (ii) to evaluate the agreement between real-time gray-scale ultrasound, sonoelastography and magnetic resonance imaging with respect to these outcomes; and (iii) to evaluate the diagnostic accuracy of sonoelastography in the diagnosis of uterine pathology on stored sonoelastography and gray-scale cine loops. Women without a history of uterine pathology and with the diagnosis intrauterine fibroids or adenomyosis were included. All participants underwent gray-scale ultrasound, sonoelastography and magnetic resonance imaging. Compression sonoelastography was found to have high inter-observer and inter-method agreement for the measurement of uterine and fibroid volumes. The addition of sonoelastography to gray-scale ultrasound seems to be useful in the differentiation between fibroids, adenomyosis and normal uteri as reflected by an increase in accuracy and diagnostic agreement.

Use of Contrast-Enhanced Ultrasound in the Assessment of Uterine Fibroids: A Feasibility Study.

Contrast-enhanced ultrasound (CEUS) is an innovative ultrasound technique capable of visualizing both the macro- and microvasculature of tissues. In this prospective pilot study, we evaluated the feasibility of using CEUS to visualize the microvasculature of uterine fibroids and compared CEUS with conventional ultrasound. Four women with fibroids underwent gray-scale ultrasound, sonoelastography and power/color Doppler scans followed by CEUS examination. Analysis of CEUS images revealed initial perfusion of the peripheral rim, that is, a pseudo-capsule, followed by enhancement of the entire lesion through vessels traveling from the exterior to the interior of the fibroid. The pseudo-capsules exhibited slight hyper-enhancement, making a clear delineation of the fibroids possible. The centers of three fibroids exhibited areas lacking vascularization, information not obtainable with the other imaging techniques. CEUS is a feasible technique for imaging and quantifying the microvasculature of fibroids. In comparison with conventional ultrasound imaging modalities, CEUS can provide additional diagnostic information based on the microvasculature.

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

OBJECTIVE: To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. DESIGN: Stepped-wedge cluster randomised controlled trial. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. INTERVENTIONS: An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. RESULTS: Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95% CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). CONCLUSIONS: Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. TRIAL REGISTRATION NUMBER: NTR2933; Results.

Cost-effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: economic evaluation alongside a stepped-wedge cluster-randomised trial.

OBJECTIVES: To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. DESIGN: Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. INTERVENTION: The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. RESULTS: At 12 months, there were no statistically significant differences in total societal costs (€-647; 95% CI €-2116 to €753) and duration until RTW (-4.1; 95% CI -10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. CONCLUSIONS: Considering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. TRIAL REGISTRATION NUMBER: NTR2933; Results.

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.

Role of 3-Dimensional Sonography in the Assessment of Submucous Fibroids: A Pilot Study.

OBJECTIVES: To investigate the accuracy and reliability of 3-dimensional (3D) transvaginal sonography in classifying submucous fibroids using the International Federation of Gynecology and Obstetrics PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) classification and protrusion (percent) compared to 2-dimensional (2D) transvaginal sonography, 2D saline infusion sonography, and 3D saline infusion sonography, using hysteroscopy as a reference test. METHODS: A prospective cohort pilot study was performed among 14 consecutive patients undergoing hysteroscopic surgery, preceded by routine sonography (2D transvaginal sonography, 2D saline infusion sonography, 3D transvaginal sonography, and 3D saline infusion sonography). RESULTS: The intraclass correlation coefficient (ICC) for 2D transvaginal sonography versus hysteroscopy was 0.69 (95% confidence interval [CI], 0.06, 0.90) compared to 0.94 (95% CI, 0.83, 0.98) for 2D saline infusion sonography. The ICCs for 3D transvaginal sonography versus hysteroscopy were 0.69 (95% CI, 0.03, 0.90 [investigator A]) and 0.55 (95% CI, -0.48, 0.86 [investigator B]). The ICCs for 3D saline infusion sonography versus hysteroscopy were 0.94 (95% CI, 0.81, 0.98 [investigator A]) and 0.87 (95% CI, 0.60, 0.96 [investigator B]). Interobserver agreement of 3D transvaginal sonography was 0.81 (95% CI, 0.43, 0.94) compared to 0.86 (95% CI, 0.56, 0.96) for 3D saline infusion sonography. CONCLUSIONS: In these preliminary data, 3D transvaginal sonography was not as accurate as 2D or 3D saline infusion sonography and was not more accurate than 2D transvaginal sonography. There was moderate interobserver agreement for 3D transvaginal sonography. There might be room for improvement, as 3D transvaginal sonography is more accurate when endometrial thickness increases. Further study is warranted to evaluate in which patients saline infusion sonography eventually can be obviated.

IDEAL framework in surgical innovation applied on laparoscopic niche repair.

The research objective of the current systematic literature review is to classify the laparoscopic niche repair according to the IDEAL framework of 'innovation stages' and to recommend the required research setting to facilitate safe and properly timed implementation of the technique. In doing so, we are also able to evaluate the practical applicability of the IDEAL framework. A systematic search of the available literature on laparoscopic niche repair was performed in PubMed, Embase, and the Wiley/Cochrane library. Articles were classified according to the IDEAL framework and recommendations were given on additional required research before the technique can be safely implemented. Practical applicability of the IDEAL framework was also evaluated. Introduction of laparoscopic niche repair matches Idea (1) and Development (2a), according to the stages of IDEAL framework, although most studies are retrospective and complications have not been registered structurally in a considerable number of the articles. As feasibility and safety have been more or less established and surgery has been further developed we enter stage 2b (Exploration) and need prospective trials preferably comparing the effectiveness of laparoscopic niche repair to expectant management, the current standard care. Available studies were classified with the use of the IDEAL framework, achieving an overall IDEAL stage to be 2a Development. As clinical outcomes, though poorly registered, have been substantially improved, laparoscopic niche repair needs to be carried forward by more advanced study designs.

Niches after cesarean section in a population seeking hysteroscopic sterilization.

OBJECTIVE: To study the prevalence of hysteroscopically evaluated disruptions of the integrity of the uterine wall ('niches') in women with and without a previous cesarean section. STUDY DESIGN: A prospective cohort study was performed in a teaching hospital in the Netherlands. Women seeking hysteroscopic sterilization were included. A hysteroscopic evaluation of the anterior wall of the uterus and cervix to identify the existence of disruptions (niches) was performed in a standard manner. Primary outcome was the presence of a uterine niche, defined as any visible defect, disruption, or concavity (gap) in the anterior wall. Secondary outcome was to develop a registration form of niche features for hysteroscopic evaluation. RESULTS: In total, 713 women were included, 603 without and 110 with a previous cesarean section. In women with a previous cesarean Section 83 (75%) niches were observed using hysteroscopy. Anterior wall disruptions were not observed in women without a cesarean section. The following niche features were identified and incorporated in a registration form: polyps, cysts, myometrium defect, fibrotic tissue, (abnormal) vascular pattern, lateral branches, mucus production inside the defect, and bleeding. CONCLUSION: In a prospective cohort study among women undergoing hysteroscopic sterilization, a uterine niche could be detected by hysteroscopy in 75% of women with a previous cesarean section.

Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial.

OBJECTIVE: To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs). DESIGN: Multicenter; women and assessors blinded prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): A total of 152 women with a miscarriage of <14 weeks with at least one previous D&C for miscarriage or termination of pregnancy. INTERVENTION(S): Women were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A follow-up diagnostic hysteroscopy was scheduled 8-12 weeks after the D&C procedure. MAIN OUTCOME MEASURE(S): The primary outcome was the number of women with IUAs and the secondary outcome was the severity of IUAs. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The IUAs were observed in 10 (13.0%) and 22 women (30.6%), respectively (relative risk, 0.43; 95% confidence interval 0.22-0.83). Mean adhesion score and the amount of moderate-to-severe IUAs were significantly lower in the intervention group according to the American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions. CONCLUSION(S): Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Prognostic Factors for Niche Development in the Uterine Caesarean Section Scar.

In a prospective study on 134 women after their first cesarean section prognostic factors for developing an uterine niche (scar defect) measured with sonohysterography were evaluated. With multivariable logistic regression anlaysis the following prognostic factors were identified; enlarged cervical dilatation and induction of labour. Contractions before labour reduced the risk for niche development. The predictive value of the model made with this prognostic factors was low. The development of a niche is a multifactorial proces and more studies are needed.

Long-term complications and reproductive outcome after the management of retained products of conception: a systematic review.

OBJECTIVE: To examine the long-term complications and reproductive outcomes after the management of retained products of conception (RPOC). DESIGN: Systematic review. SETTING: Not applicable. PATIENT(S): Women suspected of RPOC who were subjected to medical therapy with misoprostol or surgical treatment. INTERVENTION(S): An electronic literature search was conducted in June 2015 using MEDLINE, EMBASE, and the Cochrane library. We included clinical trials in which women were consecutively included, independent of their symptoms. MAIN OUTCOME MEASURE(S): The prevalence of intrauterine adhesions (IUAs) and reproductive outcomes. RESULT(S): No studies reporting on IUAs or reproductive indicators after medical management with misoprostol were found. We included 10 cohort studies with poor to average methodological quality. Five cohort studies (n = 339) reported IUAs in 22.4% (95% confidence interval, 18.3%-27%) of women hysteroscopically evaluated. Significantly more IUAs were encountered after dilation and curettage (D&C) compared with after hysteroscopic resection (HR): 30% vs. 13%. Incomplete evacuation was encountered in, respectively, 29% and 1% of the D&C and HR cases. Similar conception, ongoing pregnancy, live-birth, and miscarriage rates were reported after D&C and HR in six cohort studies (n = 380), and there was a tendency toward earlier conception after HR. The reproductive outcomes were not reported in relation to IUAs. CONCLUSION(S): HR may be a preferable surgical treatment in women suspected of RPOC; fewer IUAs and incomplete evacuations are encountered, while similar reproductive outcomes were reported compared with D&C. Confirmation of the observed effects is required, and trials evaluating medical treatment with misoprostol as well as expectant management are urgently needed.

Effectiveness and feasibility of hysteroscopic sterilization techniques: a systematic review and meta-analysis.

OBJECTIVE: To assess whether hysteroscopic sterilization is feasible and effective in preventing pregnancy. Secondarily, to identify risk factors for failure of hysteroscopic sterilization. DESIGN: A systematic review and meta-analysis. SETTING: Not applicable. PATIENT(S): Women undergoing hysteroscopic sterilization. INTERVENTION(S): Hysteroscopic sterilization with a commercially available system (Ovabloc Intra Tubal Device, Essure system, or Adiana permanent contraception system). MAIN OUTCOME MEASURE(S): Successful placement at first attempt, confirmed correct placement, complications, incidence of pregnancy, and risk factors for placement failure in hysteroscopic sterilization. RESULT(S): Of the 429 citations identified, 45 articles were eligible for analyses. No randomized controlled trials (RCTs) were identified, just cohort studies. Six articles concerned Ovabloc, 37 Essure, and two Adiana sterilization. The probabilities for successful bilateral placement in a first attempt for Ovabloc, Essure, and Adiana, were, respectively, in the ranges 78%-84%, 81%-98%, and 94%. The probabilities of successful bilateral placement could not be pooled because of substantial heterogeneity. The 36 months' cumulative pregnancy rate of Adiana was 16 of 1,000. Reliable pregnancy rates after sterilization with Ovabloc or Essure method could not be calculated. For all three hysteroscopic techniques, the incidence of complications and their severity has not been studied adequately and remains unclear. We also found too little evidence to identify risk factors for placement failure. CONCLUSION(S): Sterilization by hysteroscopy seems feasible, but the effectiveness and risk factors for failure of sterilization remain unclear owing to the poor-quality evidence. Both currently applied hysteroscopic sterilization techniques and the coming new techniques must be evaluated properly for feasibility and effectiveness. Appropriate RCTs and observational studies with sufficient power and complete and long-term (>10 years) follow-up data on unintended pregnancies and complications are needed.

Reproducibility of three-dimensional ultrasound for the measurement of a niche in a caesarean scar and assessment of its shape.

OBJECTIVE: To evaluate the inter- and intraobserver agreement for measurement of the size and volume of a niche and assessment of the shape, with the use of three-dimensional (3D) ultrasound. STUDY DESIGN: In this reproducibility study, 20 3D ultrasound volumes of uteri with a niche were selected, based on complete visualisation of the uterus and niche in both the longitudinal and transversal plane. Niche measurements were performed off-line twice by one observer and once by another observer. Niche measurements and assessment of shape were performed in the longitudinal and transversal plane, and niche volume in the longitudinal plane. The mean difference, 95% limits of agreement, the intraclass correlation coefficient (ICC) and Cohen's kappa were calculated to assess the inter- and intraobserver agreement. RESULTS: The interobserver agreement was excellent for all niche measurements (ICC >0.86), including depth and residual myometrial thickness (RMT), except for width at niche base in the transversal plane (ICC 0.74) and niche volume (ICC 0.79), which were classified as good agreement. Wide limits of agreement and a high mean difference were found for maximal width in the transversal plane. The intraobserver agreement was excellent for all measurements (ICC >0.80), except for RMT in the longitudinal and transversal plane, which were classified as good agreement (ICC 0.73 and 0.62, respectively). Wide limits of agreement were found for maximal width and width at niche base in the transversal plane. The overall agreement in the transversal plane was lower than in the longitudinal plane, but still all in the range of good agreement. The inter- and intraobserver agreement was good to poor for the assessment of niche shape. CONCLUSION: Using 3D ultrasound, various niche parameters, including depth (both perpendicular to niche base and maximal depth), maximal width, width at niche base, RMT and volume, can be measured with a high level of agreement, in particular if measured in the longitudinal plane.