Perceived health status after mid-urethral sling revision in 287 women from the VIGI-MESH registry: A cross-sectional study.

OBJECTIVE: To evaluate the health status and recovery of women after mid-urethral sling (MUS) revision in response to complications. DESIGN: Cross-sectional study using a questionnaire sent to women from a registry. SETTING: Twenty-two French surgical centres. POPULATION: A total of 287 women from the VIGI-MESH registry responded, having undergone MUS revision for complications. METHODS: Our sample of women were compared against a representative set of French women taken from the Eurostat database. Multivariate analysis was performed to identify clinical predictors for successful MUS revision. A qualitative analysis was carried out on free-text comments. MAIN OUTCOME MEASURES: Health status, defined by the Minimum European Health Module, and recovery, assessed by Patient Global Impression of Improvement. RESULTS: The response rate was 76% (287/378), with 49% of the women (141/287, 95% CI 43%-55%) reporting good health status, which was 8 points lower than that expected from the comparator French set (57%, 95% CI 55%-58%). Overall, 53% (147/275, 95% CI 47%-59%) of the women reported feeling much better after MUS revision. Just over one-third (35%, 95/275, 95% CI 29%-40%) of respondents reported poor health with little or no improvement. Multivariate analysis showed that being operated on for pain at revision was associated with worse self-perceived health than being operated on for exposure (OR 0.6, 95% CI 0.14-0.95); women with pre-existing comorbidity reported a poorer health status following MUS revision (OR 0.22, 95% CI 0.13-0.38). CONCLUSIONS: Our results suggest that half of the women recovered good health status after MUS revision, whereas a proportion appeared to be seriously affected by an MUS complication despite the revision.

Screening women in young adulthood for disabling dysmenorrhoea: a nationwide cross-sectional study from the CONSTANCES cohort.

RESEARCH QUESTION: How do different warning indicators help to identify disabling dysmenorrhoea among women in young adulthood? DESIGN: A nationwide cross-sectional study of women aged 18-25 years from the CONSTANCES cohort was constructed. Disability was assessed with the Global Activity Limitation Indicator question 'For the past 6 months, have you been limited in routine activities?Yes, severely limited/Yes, limited/ No, not limited'. Dysmenorrhoea pain intensity and other chronic pelvic pain symptoms (dyspareunia and non-menstrual pain) were evaluated according to questions from a specific questionnaire. Probability of disability was estimated using a logistic prediction model according to dysmenorrhoea intensity, other indicators of pelvic pain symptoms and other obvious covariates. The results of the predictive model of disabling dysmenorrhoea were presented on a nomogram. RESULTS: Among 6377 women, the rate of disability was estimated at 7.5%. Increased intensity of dysmenorrhoea (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.04-1.13), increased frequency of dyspareunia (from OR 1.69, 95% CI 1.33-2.14 up to OR 3.41, 95% CI 2.16-5.38) non-menstrual chronic pelvic pain (OR 1.75, 95% CI 1.40-2.19), body mass index over 25 kg/m2 (OR 1.45, 95% CI 1.17-1.80) and non-use of the hormonal contraceptive pill (OR 1.29, 95% CI 1.05-1.59) were significantly associated with disability. According to the nomogram, a predicted probability of 15% or more could be chosen as a threshold. This represents almost 4.6% of young women in this sample being classified at risk of disabling dysmenorrhoea. CONCLUSIONS: Dysmenorrhoea pain intensity and associated pelvic pain symptoms are warning indicators that can be measured to help screen young women who may suffer from disabling dysmenorrhoea.

French college of gynecologists and obstetricians (CNGOF) recommendations for clinical practice: Place of breast self-examination in screening strategies.

Breast cancer is the most common female cancer in the world. Numerous studies have shown that the risk of metastatic disease increases with tumor volume. In this context, it is useful to assess whether the regular practice of formal breast self-examination (BSE) as opposed to breast awareness has an impact on the number of cancers diagnosed, their stage, the treatments used and mortality. DESIGN: The Commission of Senology (CS) of the Collège National de Gynécologie et Obstétrique Français (CNGOF) respected and followed the Grading of Recommendations Assessment, Development and Evaluation method to assess the quality of the evidence on which the recommendations were based. METHODS: The CS studied 16 questions individualizing four groups of women (general population, women aged over 75, high-risk women, and women previously treated for breast cancer). For each situation, it was determined whether the practice of BSE versus abstention from this examination led to detection of more breast cancers and/or recurrences and/or reduced treatment and/or increased survival. RESULTS: BSE should not be recommended for women in the general population, who otherwise benefit from clinical breast examination by practitioners from the age of 25, and from organized screening from 50 to 74 (strong recommendation). In the absence of data on the benefits of BSE in patients aged over 75, for those at high risk and those previously treated for breast cancer, the CS was unable to issue recommendations. Thus, if women in these categories wish to undergo BSE, information on the benefits and risks observed in the general population must be given, notably that BSE is associated with a higher number of referrals, biopsies, and a reduced quality of life.

Impact of educational workshops to increase awareness of pelvic floor dysfunction and integrate preventive lifestyle habits.

OBJECTIVES: Our objectives were to evaluate the impact of group pelvic floor education workshops on participants' knowledge, their satisfaction, and the modification of their urinary and digestive behaviors, and to compare health care providers' (HCP) knowledge with that of the general population. METHODS: For this prospective observational study, group pelvic floor education workshops were proposed between May 2021 and June 2022 in a web-conference format. Each workshop covered pelvic floor anatomy and physiology, urinary and digestive physiology as well as risk factors of PFD and preventive measures. At the start and the end of the workshops, participants completed a questionnaire on their knowledge and their beliefs about the pelvic floor. Questions about their satisfaction were asked at the end of the workshops. A 2-month questionnaire assessed changes in urinary and digestive habits and whether participants had talked about the workshop around them. RESULTS: A total of 856, with an average age 40.1 years, participated and completed the questionnaires before and after the workshops; 694 responded at 2 months. The education workshops significantly improved knowledge about the pelvic floor in the "HCP" and "non-HCP" groups. At 2 months, 591 participants (85.2%) 85.2% had talked about the workshop content; 557 (80.3%) reported having changed, or planned to change, their urinary behaviors and 495 (71.3%) their defecatory behaviors. CONCLUSIONS: Pelvic floor education workshops can increase level of knowledge and thus limit risky behaviors for the pelvic floor. The high rate of participation and the satisfaction of the participants shows the interest for the theme.

Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Episiotomy practice in France and prevention of high-grade perineal tears at the time of operative vaginal delivery: a prospective multicentre ancillary cohort study.

INTRODUCTION AND HYPOTHESIS: Evidence suggests that episiotomies reduce the risk for obstetric anal sphincter injuries (OASIs) in operative vaginal deliveries (OVDs). However, there is limited evidence on the importance of episiotomy technique in this context. The primary objective of this study was to assess if an episiotomy suture angle >45° from the median line would be associated with a lower risk for OASIs at the time of OVD. METHODS: This was an ancillary study from the multicentre prospective cohort INSTRUMODA study. Of the 2,620 patients who had an OVD with a concomitant episiotomy between April 2021 and March 2022, a total of 219 fulfilled the inclusion criteria. Post-suturing photographs were used to assess episiotomy characteristics. RESULTS: Based on suture angles of ≤45° and >45° the study cohort was categorized into groups A (n = 155) and B (n = 64) respectively. The groups had comparable demographic and birth-related characteristics. The mean episiotomy length was significantly longer in group A than in group B (3.21 cm vs 2.84 cm; p = 0.009). Senior obstetricians performed more acute angled episiotomies than junior residents (p = 0.016). The total prevalence of OASIS was 2.3%, with no significant difference in rate of OASI between the two study groups. Birthweight was significantly higher in OASI births (p = 0.018) and spatula-assisted births were associated with higher risk for OASIs than ventouse or forceps (p = 0.0039). CONCLUSIONS: This study did not demonstrate a significant reduction in risk for OASI at the time of OVD when the episiotomy suture angle was >45° from the median line. However, these results should be interpreted with caution owing to the low prevalence of OASIs in our cohort.

[Place of breast self-examination in screening strategies. French College of Gynecologists and Obstetricians (CNGOF) recommendations for clinical practice]. / Recommandations pour la pratique clinique du CNGOF. Place de l'auto-examen des seins dans les stratégies de dépistage.

OBJECTIVES: Breast cancer is the most common female cancer in the world. In France, over 60,000 new cases are currently diagnosed, and 12,000 deaths are attributed to it annually. Numerous studies have shown that the risk of metastatic disease increases with tumor volume. In this context, it is useful to assess whether the regular practice of breast self-examination (BSE) has an impact on the number of cancers diagnosed, their stage, the treatments used and mortality. DESIGN: the CNGOF's Commission de Sénologie (CS), composed by 17 experts and 3 invited members, drew up these recommendations. No funding was provided for the development of these recommendations. The CS respected and followed the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method to assess the quality of the evidence on which the recommendations were based. METHODS: The CS studied 16 questions concerning BSE, individualizing four groups of women (general population, women aged over 75, high-risk women, and women previously treated for breast cancer). For each situation, it was determined whether the practice of BSE compared with abstention from this examination led to the detection of more breast cancers and/or recurrences and/or reduced treatment and/or increased survival. RESULTS: BSE should not be recommended for women in the general population, who otherwise benefit from a clinical breast examination (by the attending physician or gynecologist) from the age of 25, and from organized screening from 50 to 74 (strong recommendation). However, in the absence of data on the role of BSE in patients aged over 75, those at high risk of breast cancer and those previously treated for breast cancer, the CS was unable to issue recommendations. Thus, if women in these latter categories wish to undergo BSE, they must be given rigorous training in the technique, and information on the benefits and risks observed in the general population. Finally, the CS invites all women who detect a change or abnormality in their breasts to consult a healthcare professional without delay. CONCLUSION: BSE is not recommended for women in the general population. No recommendation can be established for women aged over 75, those at high risk of breast cancer and those previously treated for breast cancer.

In vivo measurement of the elastic properties of pelvic floor muscles in pregnancy using shear wave elastography.

OBJECTIVE: We aimed to investigate changes in the elastic properties of levator ani muscle (LAM) and external anal sphincter (EAS) during pregnancy using shear wave elastography (SWE). Our secondary objective was to examine the association between the elastic properties of pelvic floor muscles (PFM) and perineal tears at childbirth. METHODS: This was a prospective monocentric study, including nulliparous women. Three visits were planned (14-18, 24-28, and 34-38 weeks) with a SWE assessment of the LAM and EAS at rest and during Valsalva maneuver. Then, we collected data about the delivery's characteristics. Assessments were performed using an Aixplorer V12® device (SL 18-5 linear probe) using a transperineal approach, reporting the shear modulus in kPa. We looked for changes in PFM's elastic properties during pregnancy using one-way ANOVA for repeated measures. We compared the mean shear modulus in late pregnancy for each muscle and condition between women with an intact perineum at delivery and those with a perineal tear using Student's t test. RESULTS: Forty-seven women were considered. Forty-five women had vaginal delivery of which 38 (84.4%) had perineal tears. We did not report any significant changes in the elastic properties of PFM during pregnancy. Women with an intact perineum at delivery had a stiffer EAS at Valsalva maneuver in late pregnancy (27.0 kPa vs. 18.2 kPa; p < 0.005). CONCLUSIONS: There were no significant changes in the elastic properties of the PFM in pregnancy. Stiffer EAS in late pregnancy appears to be associated with a lower incidence of perineal tears.

Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial.

Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.

Do Surgeons Anticipate Women's Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial.

Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse.

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan-Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien-Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

In vivo assessment of the elastic properties of the external anal sphincter in term pregnant women using shear wave elastography.

INTRODUCTION AND HYPOTHESIS: The objective was to assess the intraobserver intersession and interobserver intrasession reliability of shear wave elastography applied to the external anal sphincter in term pregnant women. METHODS: This prospective study involved nulliparous pregnant women at 37 weeks or more with two visits (V1: one observer; V2 two observers) planned within a 12-h to 7-day interval. Measurements were performed using an Aixplorer V12® device with an SL 18-5 linear probe using a transperineal approach, allowing a measurement of the shear modulus (SM) in kPa. Measures were performed at rest, Valsalva maneuver, and maximal contraction. Reliability was assessed using the intraclass correlation coefficient (ICC). The study was approved by an ethics committee (ID RCB: 2020-A00764-65). RESULTS: A total of 37 women were included. Intraobserver reliability was excellent at rest (ICC = 0.91 [0.84-0.95) and good during the Valsalva maneuver (ICC = 0.83 [0.72-0.90]) and contraction (ICC = 0.85 [0.75-0.91]). Interobserver reliability was good at rest (ICC = 0.79 [0.66-0.87]) and during Valsalva (ICC = 0.84 [0.73-0.90]), but moderate during contraction (ICC = 0.70 [0.53-0.82]). CONCLUSIONS: Shear wave elastography is a reliable tool for assessing the elastic properties of the external anal sphincter in term pregnant women.

Management of female pelvic organ prolapse-Summary of the 2021 HAS guidelines.

When a patient presents with symptoms suggestive of pelvic organ prolapse (POP), clinical evaluation should include an assessment of symptoms, their impact on daily life and rule out other pelvic pathologies. The prolapse should be described compartment by compartment, indicating the extent of the externalization for each. The diagnosis of POP is clinical. Additional exams may be requested to explore the symptoms associated or not explained by the observed prolapse. Pelvic floor muscle training and pessaries are non-surgical conservative treatment options recommended as first-line therapy for pelvic organ prolapse. They can be offered in combination and be associated with the management of modifiable risk factors for prolapse. If the conservative therapeutic options do not meet the patient's expectations, surgery should be proposed if the symptoms are disabling, related to pelvic organ prolapse, detected on clinical examination and significant (stage 2 or more of the POP-Q classification). Surgical routes for POP repair can be abdominal with mesh placement, or vaginal with autologous tissue. Laparoscopic sacrocolpopexy is recommended for cases of apical and anterior prolapse. Autologous vaginal surgery (including colpocleisis) is a recommended option for elderly and fragile patients. For cases of isolated rectocele, the posterior vaginal route with autologous tissue should be preferentially performed over the transanal route. The decision to place a mesh must be made in consultation with a multidisciplinary team. After the surgery, the patient should be reassessed by the surgeon, even in the absence of symptoms or complications, and in the long term by a primary care or specialist doctor.

How Women Perceive Severity of Complications after Pelvic Floor Repair?

BACKGROUND: The Clavien-Dindo classification, used to describe postoperative complications, does not take into account patient perception of severity. Our main objective was to assess women's perception of postoperative pelvic floor repair complications and compare it to the classification of Clavien-Dindo. METHODS: Women and surgeons participating in the VIGI-MESH registry concerning pelvic floor repair surgery were invited to quote their perception of complication severity through a survey based on 30 clinical vignettes. For each vignette, four grades of severity were proposed: "not serious", "a little serious", "serious", "very serious". RESULTS: Among the 1146 registered women, we received 529 responses (46.2%) and 70 of the 141 surgeons (49.6%) returned a completed questionnaire. A total of 25 of the 30 vignettes were considered classifiable according to the Clavien-Dindo classification. The women's classification was concordant with Clavien-Dindo for 52.0% (13/25) of the classifiable vignettes. The women's and surgeons' responses were discordant for 20 of the 30 clinical vignettes (66.7%). Loss of autonomy (self-catheterization, long-term medication use) or occurrence of sequelae (organ damage or severe persistent pain) were perceived by women as more serious than Clavien-Dindo classification or than surgeons' perceptions. CONCLUSIONS: Women's perception of pelvic floor repair surgery seems different from the Clavien-Dindo classification. Lack of repair and long-term disability seem to be two major factors in favor of perception of the surgical complication as serious.

French guidelines for restrictive episiotomy during instrumental delivery were not followed by an increase in obstetric anal sphincter injury.

The objective was to assess the influence of the French guidelines in favor of a restrictive use of episiotomy on both episiotomy and obstetric anal sphincter injury (OASI) rates during instrumental delivery. It was aulticenter study involving 193 maternities between 2000 and 2016. We included women with a singleton pregnancy, with cephalic presentation at 34 weeks of gestation or more who underwent an instrumental delivery. The study period was divided into three phases: 2000-2005 (reference) 2006-2011, and 2012-2016. We calculated the adjusted relative risk (aRR) of episiotomy and OASI and investigated for changes in episiotomy and OASI rates over time by using Prais-Winsten regression. We considered 96,035 deliveries. The episiotomy's risk was lower in 2006-2011 (69.4%) and 2012-2016 (59.1%) compared to 2000-2005 (81.2%), respectively: aRR 0.93 [0.92-0.95] and 0.89 [0.87-0.90]. The OASI's risk was higher in 2006-2011 (2.5%) and 2012-2016 (3.1%) compared to 2000-2005, respectively: aRR 1.30 [1.10-1.53]) and 1.57 [1.33-1.85]. However, Prais-Winsten regression showed no difference in the OASI rate during the study period. We observed a massive decrease in episiotomy use and a moderate increase in crude OASI's rate but multivariate analysis failed to report an association between these outcomes.

Cephalic marks and well-being in newborns after operative vaginal delivery.

OBJECTIVES: To compare the incidence of cephalic marks in newborns exposed to operative vaginal delivery and those who are not. We examined the factors associated with alterations in neonatal well-being and with cephalic mark occurrence. METHODS: Prospective study involving singleton term newborns delivered in a cephalic presentation. Newborns in the operative group were matched with newborns born on the same day without instruments required. A cephalic mark was defined as any mark or edema on the newborn's skin between 12 and 72 hours of life. Neonatal well-being was assessed by analgesic consumption, neonatal discomfort (EDIN score of 1 or more), and prolonged hospitalization (4 days or more). We compared the operative and spontaneous groups and determined the relative risk (RR) for cephalic marks. We investigated the factors associated with alterations in neonatal well-being and factors associated with cephalic mark occurrence in the case of operative delivery using multivariate logistic regression analysis. RESULTS: A total of 135 newborns were included in each group. The incidence of cephalic marks was higher in the operative group (RR = 13.3 [6.0-29.5]). In case of operative delivery, cephalic marks were associated with neonatal discomfort (adjusted odds ratios [aOR] = 8.2 [2.2-30.6]) and analgesic consumption (aOR = 3.0 [1.2-7.1]). The number of cephalic marks was higher in cases with sequential use of vacuum and forceps (aOR = 3.5 [1.1-11.7]) and forceps only deliveries (aOR = 3.0 [1.1-8.1]) relative to vacuum only deliveries. CONCLUSIONS: Operative delivery increases the risk of neonatal cephalic marks, which can negatively affect neonatal well-being.

[Non-genetic indications for risk reducing mastectomies: Guidelines of the National College of French Gynecologists and Obstetricians (CNGOF)]. / Indications des mastectomies de réduction de risque en dehors du risque avéré de prédisposition héréditaire : recommandations du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: To determine the value of performing a risk-reducting mastectomy (RRM) in the absence of a deleterious variant of a breast cancer susceptibility gene, in 4 clinical situations at risk of breast cancer. DESIGN: The CNGOF Commission of Senology, composed of 26 experts, developed these recommendations. A policy of declaration and monitoring of links of interest was applied throughout the process of making the recommendations. Similarly, the development of these recommendations did not benefit from any funding from a company marketing a health product. The Commission of Senology adhered to the AGREE II (Advancing guideline development, reporting and evaluation in healthcare) criteria and followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method to assess the quality of the evidence on which the recommendations were based. The potential drawbacks of making recommendations in the presence of poor quality or insufficient evidence were highlighted. METHODS: The Commission of Senology considered 8 questions on 4 topics, focusing on histological, familial (no identified genetic abnormality), radiological (of unrecognized cancer), and radiation (history of Hodgkin's disease) risk. For each situation, it was determined whether performing RRM compared with surveillance would decrease the risk of developing breast cancer and/or increase survival. RESULTS: The Commission of Senology synthesis and application of the GRADE method resulted in 11 recommendations, 6 with a high level of evidence (GRADE 1±) and 5 with a low level of evidence (GRADE 2±). CONCLUSION: There was significant agreement among the Commission of Senology members on recommendations to improve practice for performing or not performing RRM in the clinical setting.

Early identification of women with endometriosis by means of a simple patient-completed questionnaire screening tool: a diagnostic study.

OBJECTIVES: To assess the value of a self-completed questionnaire based on patients' verbal descriptors of pelvic painful symptoms to identify women with endometriosis. DESIGN: Prospective 1:2 nonmatched case-control study. SETTING: Three French endometriosis referral centers. PATIENT(S): Endometriosis cases were women aged 18-45 years with endometriosis confirmed by histology. Controls were as follows: asymptomatic women attending a gynecologic consultation for routine examination; women without evidence of endometriosis consulting for pain/infertility; and population-based controls from the same urban locations. INTERVENTION(S): All women completed the 21-item yes/no questionnaire about painful symptoms. MAIN OUTCOME MEASURE(S): The area under the receiver operating characteristic curve of the full question set model based on binary logistic regression and the diagnostic accuracy of low- and high-risk classification rules based on selected threshold of the prediction model. RESULT(S): We included 105 cases and 197 controls (45 asymptomatic consultation-based controls, 66 women without endometriosis consulting for pain/infertility, and 86 population-based controls). The full question set prediction model, including age, had an area under the receiver operating characteristic curve of 0.92 (95% confidence interval, 0.87-0.95) after internal validation. The high-risk classification rule had a specificity of 98.0% and a positive likelihood ratio of 30.5. The low-risk classification rule had a sensitivity of 98.1% and a negative likelihood ratio of 0.03. For a hypothesized pretest prevalence of 10%, the high- and low-risk prediction rules ascertained endometriosis with posttest probability rates of 77.2% and 0.3%, respectively. CONCLUSION(S): A self-completed patient-centered questionnaire can identify women at low or high risk of endometriosis with a high diagnostic accuracy and, thus, may help early identification of women with endometriosis.

Oocyte Vitrification for Fertility Preservation in Women with Benign Gynecologic Disease: French Clinical Practice Guidelines Developed by a Modified Delphi Consensus Process.

International guidelines are published to provide standardized information and fertility preservation (FP) care for adults and children. The purpose of the study was to conduct a modified Delphi process for generating FP guidelines for BGD. A steering committee identified 42 potential FP practices for BGD. Then 114 key stakeholders were asked to participate in a modified Delphi process via two online survey rounds and a final meeting. Consensus was reached for 28 items. Among them, stakeholders rated age-specific information concerning the risk of diminished ovarian reserve after surgery as important but rejected proposals setting various upper and lower age limits for FP. All women should be informed about the benefit/risk balance of oocyte vitrification-in particular about the likelihood of live birth according to age. FP should not be offered in rASRM stages I and II endometriosis without endometriomas. These guidelines could be useful for gynecologists to identify situations at risk of infertility and to better inform women with BGDs who might need personalized counseling for FP.

The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis.

OBJECTIVES: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. METHODS: A prospective, observational, multicentre study was conducted including all women ≥18 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire's measurement properties. The minimal clinically important difference was estimated by the anchor-based method. RESULTS: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach α): (I) pain-related disability (α = 0.79), (II) painful bowel symptoms (α = 0.80), (III) dyspareunia (α = 0.83), and (IV) painful urinary tract symptoms (α = 0.77). They produced four subscores that can be summed to obtain a single score (α = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean ± SD: 46.7 ± 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10-7, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. CONCLUSIONS: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.