Vaginal Patch Plastron for cystocele repair at the time of vaginal prosthesis bashing: A technical note (with video).

Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh related complications and recommend a vaginal route without prosthesis in first intention. Surgical techniques mainly consist in anterior colporraphy, vaginal patch plastron and para vaginal repair. However, in case of vaginal patch plastron, the vagina left in contact with the bladder is a material of much better quality than colporraphy alone. The multiplication of native tissues, generating post-operative fibrosis, associated with anchorage on a strong ligamentous structure, allows to expect better outcomes compared to anterior colporraphy. Indeed, vaginal plastron corrects median cystoceles with a vaginal strip as well as lateral cystoceles thanks to bilateral paravaginal suspension. Thereby, vaginal patch plastron appears to be a good compromise between the 3 autologous techniques with median and paralateral repair We aimed to describe the surgical technique of the vaginal patch plastron for vaginal native tissue repair for cystocele.

[Impact of a service protocol on the practice of vaginal delivery of breech presentations at term]. / Impact d'un protocole de service sur la pratique de l'accouchement voie basse des présentations du siège à terme.

OBJECTIVES: The delivery of breech presentations remains controversial. Our study analysed the impact of a service protocol on the proportion of planned vaginal delivery and its success. Immediate neonatal morbidity and factors that may influence the success of vaginal delivery were studied. METHODS: Retrospective study, between 2009 and 2020 at the CHRU of Limoges, type 3 maternity hospital, on patients with a breech foetus at term. The proportion of planned vaginal delivery and the rate of effective vaginal delivery were compared before/after 2015. Neonatal morbidity was compared for planned vaginal delivery and planned cesarean delivery groups. RESULTS: We included 923 patients. The rate of planned vaginal delivery was significantly higher after 2015 from 5.2% to 19% (P<0.001), with a success rate increasing from 60% to 82.1% (P=0.06). The rate of vaginal breech deliveries significantly increased from 3.8% to 17% (P<0.001). We found significantly more newborns with moderate acidosis when a vaginal delivery was attempted (P<0.001). The success of vaginal delivery was correlated to the Magnin index (P=0.044), to gestational age (P=0.037), and to multiparity (OR 3.78 95% CI [1.42-10.03] P=0.006). CONCLUSION: Our study demonstrates the benefits of setting up a service protocol for the practice of breech vaginal delivery.

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial.

BACKGROUND: Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking. METHODS: Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment). DISCUSSION: A prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension. TRIAL REGISTRATION: CHU LIMOGES is the sponsor of this research (n°87RI18_0013). This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019. The trial is registered in the ClinicalTrials.gov registry ( NCT03875989 ).

Robot-assisted laparoscopic auto-graft of patchwork ovarian cortex in two steps.

The main difficulty of ovarian tissue autograft (OTA) is to preserve as many follicles as possible because the ovarian tissue undergoes warm ischemia during grafting until revascularisation, resulting in significant follicular loss. We describe a two-stage grafting technique to stimulate new vascularisation in order to enhance the revascularization process to reduce the ischemic injuries. Furthermore we performed ovarian patchwork in the laboratory and then grafting with robotic laparoscopy to facilitate surgery and increase precision. This technique is used in the DATOR study with promising results, such as a 40% delivery rate.

[External validation of FullPIERS model for prediction of adverse outcomes among women with pre-eclampsia in French maternity of 2014 to 2018]. / Validation externe du modele FullPIERS dans la pré-éclampsie à partir d'une série française de 4 ans.

OBJECTIVES: FullPIERS score (Pre-eclampsia Integrated Estimate of RiSk) is built in order to predict maternal outcomes among women with preeclampsia. Our objective is to assess external validity of this score among a population of French women. METHODS: A retrospective study was conducted for all patients with pre-eclampsia (severe or not) admitted to a tertiary hospital center. A receiver operating characteristic (ROC) curve was constructed to determine accuracy of the model at 48 hours and 7 days after admittance and area under the curve (AUC) was calculated. RESULTS: In total, 276 patients meet inclusions criterion. Among them, 217 were included and 61 (28 %) had one or more complication. Only 8 patients had two complications at two different moments (one at 48 hours and one at 7 days). The FullPiers score predicted maternels events at 48 hours with an area under the curve at 0.80 (IC95 % [0.74-0.85]). At 4.2 cut off, the sensitivity was 71 % and specifity 88 %. At 7 days, the area under the curve was 0.74 (IC95 % [0.67-0.79]), admiting a cutoff point for FullPIERS probability of 3.4, sensitivity was 59 % and specificity 85 %. CONCLUSIONS: Our study show utility of FullPIERS score in french maternity. This model might be a useful tool for predicting complications in women with pre-eclampsia. Using of this score in clinical practice might help improving optimization of patient's care.

Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial.

BACKGROUND: Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery. METHODS: RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality. DISCUSSION: This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus. TRIAL REGISTRATION: Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).

Fetal supraventricular tachycardia and cystic fibrosis: Coincidence or association? Two case reports.

Prenatal diagnosis of cystic fibrosis (CF) is difficult and is mainly considered upon identification of digestive sonographic signs. Although such an association has never been described until now to our knowledge, we report two cases of fetal arrhythmia associated with cystic fibrosis. This association may be explained by the physiopathology of heart in the context of CF, but nevertheless needs to be confirmed by other reports. The prenatal diagnosis of CF is important in order to implement early appropriate care, with better prognosis. The finding of possibly new associated prenatal signs may then improve the global management of the disease.

[Risk of axillary recurrence after sentinel lymph node biopsy before neoadjuvant chemotherapy in breast cancer]. / Récidive axillaire après prélèvement du ganglion sentinelle avant chimiothérapie néoadjuvante dans le cancer du sein.

OBJECTIVES: In case of large breast cancer, neoadjuvant chemotherapy (NAC) can be performed to reduce the size of the tumor and thus perform a conservative surgery. The place of the sentinel lymph node biopsy (SLNB) in case of NAC is still debated. The main aim of this study is to assess the risk of axillary recurrence after negative SLNB before NAC. METHODS: It is a retrospective, observational and uni-centric study. We included 18 to 80-year-old patients with unilateral breast cancer requiring a NAC and with a negative SLNB before NAC. Our primary endpoint was axillary recurrence. RESULTS: Between August 2006 and October 2016, 64 patients had a negative GS performing before a NAC and did not benefit from axillary dissection after NAC. The average duration of follow-up was 37 months. During our follow-up, we did not find any cases of axillary recurrence. CONCLUSION: This study supports the reliability of lymph node status assessment using the SLNB before CNA.

[Cervical ripening after previous cesarean section with dinoprostone vaginal insert]. / Déclenchement par dinoprostone et utérus cicatriciel.

OBJECTIVES: Because, to date in France, 20 % of pregnant women had a scared uterus and because the best mean of cervical ripening is unknown and controversial, we want to evaluate efficacy and safety of dinoprostone for cervical ripening in women with previous cesarean. MATERIALS AND METHODS: We conducted a retrospective unicentric study, from 2010 to 2014, at Limoges regional university hospitals. Two hundred and sixty nine patients, with medical indication for induction of labor and scared uterus, were included and ripened with dinoprostone (Propess® and/or Prostine®). Women had unfavorable cervix with Bishop score inferior to 6. RESULTS: Overall rate of vaginal delivery was 62 %. Patients have had more of one prostaglandin in 19 % of cases; the cesarean rate was significantly higher in this case (cesarean: 55.6 % vs. vaginal delivery: 44.4 %; P=0.0043). Overall, there were respectively 4 % and 0.7 % of post-partum hemorrhage and uterine rupture. One percent of newborns had a severe acidosis (pH<7 in umbilical artery) and 1 % was admitted to the Intensive Neonatal Care Unit. CONCLUSION: Dinoprostone is an effective procedure in patients with previous cesarean section requiring labor induction, with a morbidity comparable to other methods of induction of labor.

Pregnancy and primary Sjögren's syndrome: management and outcomes in a multicentre retrospective study of 54 pregnancies.

OBJECTIVES: Primary Sjögren's syndrome (pSS) is one of the most common autoimmune diseases, mainly affecting women during the fourth decade of life. During pregnancy, the presence of anti-Ro/SSa and anti-La/SSb antibodies increases the risk of congenital heart block (CHB). Foetal and pregnancy outcomes in pregnant women with pSS compared with the general population are difficult to evaluate because of confounding factors including age and body mass index (BMI). METHOD: The aim of this case-control study was to analyse the impact of pSS in pregnant women on foetal and pregnancy outcomes. RESULTS: We enrolled 19 women with pSS (54 pregnancies) matched by age and BMI to 216 controls. Patients with pSS delivered significantly earlier (38 weeks + 3 days vs. 39 weeks + 2 days) and experienced more spontaneous abortions [< 22 weeks of gestation (WG)] than the controls [n = 16/54 (30.0%) vs. n = 1/216 (0.4%); p < 0.00001]. Preterm delivery (≤ 37+6 WG) was significantly higher in the pSS group than in the control group (29% vs. 12%, p = 0.04). pSS activity significantly affected the birthweight percentile, which was lower in pregnancies occurring after the diagnosis of pSS than in those occurring before (32.43 ± 21.57 vs. 60.46 ± 27.37; p = 0.008). No case of CHB was observed. CONCLUSIONS: pSS is responsible for an increased risk of spontaneous abortion. The duration of pregnancy is lower in patients with than without pSS, with more premature deliveries. Pregnancies that occur after the onset of the disease result in lower birthweight percentile children than when pSS is not clinically overt.

Uterus transplantation in France: for which patients?

OBJECTIVE: Uterine infertility (UI), which can be caused by a variety of congenital or acquired factors, affects several thousand women in Europe. Uterus transplantation (UTx), at the current stage of research, offers hope for these women to be both the biological mother and the carrier of their child. However, the indications of UTx still need to be defined. The main aim of the study was to describe the different etiologies of UI and other data as marital and parental status from women requesting UTx who contacted us in the framework of a UTx clinical trial. Secondarily, we discussed the potential indications of UTx and their feasibility. STUDY DESIGN: This is an observational study. RESULTS: Of a total of 139 patients with UI, 105 patients (75.5%) had uterine agenesis, making it the leading cause of UI in this sample. Among the patients with uterine agenesis, 25% had a solitary kidney and 44.7% had undergone vaginal reconstruction. Peripartum hysterectomy, hysterectomy for cancer, and hysterectomy for benign pathologies accounted for 9.4%, 7.2% and 5% of cases, respectively. Less common causes of UI included complete androgen insensitivity syndrome (2.2% of patients) and prenatal diethylstilbestrol exposure (0.7%). Approximately 14% of the women already had at least one child and 66% were in a couple living together for at least 2 years. CONCLUSION: UTx is still under evaluation and further research is under way. Nulliparous patients with no major medical or surgical history and with normal ovarian function, who meet the legal criteria for medically assisted reproduction, represent the best indications for UTx at this stage of its development.

[Uterine transplantation: is there a real demand?]. / Transplantation utérine : une demande réelle ?

OBJECTIVES: To study the demand there is for uterus transplantation (UTx). PATIENTS AND METHODS: Recent media coverage of developments in UTx prompted associations of patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and of women suffering from UI to contact us. We sent them anonymous questionnaires devised to sound out their attitude towards UTx and towards adoption and gestational surrogacy (GS). A clinical psychologist also carried out a qualitative discourse analysis. RESULTS: Sixty patients answered the questionnaire. Thirty-eight patients were married or living with a male partner. Seven patients had had a hysterectomy. Fifty-one patients had uterine agenesis. Of the 60 patients, 19 and 21, respectively, had ruled out the option of adoption or GS, and 11 would not envisage either possibility. Thirty-five patients were willing to take part in a clinical study into UTx despite the uncertainty of the outcome and the potential risks involved. Of these 35 volunteers, 23 were in a heterosexual relationship and aged ≤35 years. DISCUSSION AND CONCLUSION: For women with UI the condition is all the more distressing because there is no medical solution for it. UTx could hold out hope for some of these patients despite the complexity of the procedure and the attendant risks. Because of the feelings of vulnerability engendered by UI, any UTx programme should provide full information to patients and ensure they are carefully screened and selected.

Ex vivo model of congenital cytomegalovirus infection and new combination therapies.

INTRODUCTION: Congenital human cytomegalovirus (HCMV) infection is a major public health problem due to severe sequelae in the fetus and newborns. Currently, due to their toxicity anti-CMV treatments cannot be administered to pregnant women. We thus developed an ex vivo model of 1(st) trimester placental CMV infection to observe the route of infection across the placenta and to test the efficacy of various new drugs targeting different stages of viral cycle. METHODS: After validation of the viability of floating villi explants by ELISA ß-HCG, the kinetics of placental infection were determined by immunochemistry and qPCR in this ex vivo model. Antiviral susceptibility was determined in vitro using focus reduction assay and by qPCR in the ex vivo model. RESULTS: The ex vivo model showed viral infection in trophoblasts and mesenchymal space of floating villi. In vitro, antiviral combinations of maribavir with baïcalein or artesunate inhibited viral infection by more than 90%. On the other hand, in ex vivo model, infection was reduced by 40% in presence of maribavir and artesunate. The synergistic effect observed in vitro was not observed ex vivo. DISCUSSION: This model allowed us to understand the CMV spread in 1(st) trimester floating villi better and to analyze the anti-CMV efficacy and toxicity of new drugs that could be administered to pregnant women, either alone or in combination. CONCLUSIONS: Such an ex vivo model could be applied to other viruses such as rubella or parvovirus B19 and in new drug development.

Management of presumed benign ovarian tumors: updated French guidelines.

Transvaginal pelvic ultrasound is the first-line imaging examination for presumed benign ovarian tumors (PBOT) in adult women (Grade A). Ultrasound is sufficient for characterizing a unilocular anechoic cyst smaller than 7cm (Grade A). Magnetic resonance imaging is the recommended second-line investigation for indeterminate masses or masses larger than 7cm (Grade B). Serum CA-125 assay is not recommended for first-line diagnosis in adult women (Grade C). In women with a unilocular anechoic cyst, hormone therapy is ineffective and not recommended (Grade A). Ultrasound-guided aspiration is not recommended (Grade B). Abstention is an option in adult women with a unilocular asymptomatic anechoic cyst smaller than 10cm and no history of cancer (Grade B). If symptoms develop, laparoscopy is the gold standard for surgical treatment of PBOT (Grade A). Conservative surgical treatment (cystectomy) should be preferred to oophorectomy in pre-menopausal women without a previous history of cancer (Grade C). In cases of suspected adnexal torsion, laparoscopic surgical exploration is recommended (Grade B). Conservative treatment or detorsion without oophorectomy is recommended for pre-menopausal women regardless of the estimated torsion duration and macroscopic appearance of the ovary (Grade B). During pregnancy, expectant management is recommended for unilocular asymptomatic anechoic cysts smaller than 6cm (Grade C).

Transperineal versus transvaginal ultrasound cervical length measurement and preterm labor.

OBJECTIVE: The aim was to evaluate the agreement between and the reproducibility of transperineal and transvaginal ultrasound cervical length measurements performed by the duty obstetrical team in case of preterm labor. The acceptability of transperineal ultrasonography was also assessed. METHODS: Pregnant patients between 25 and 34 weeks of gestation with contractions and a clinically modified cervix were included. Order of ultrasonography examination (transperineal or transvaginal first) and rank of operator (resident or senior) were allocated randomly. Agreement was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman plot. The patient's discomfort and preference for either method were assessed with a questionnaire. RESULTS: 62 patients admitted for preterm labor between 25 and 34 weeks of gestation were included. Six seniors and nine residents took part in the study. Among the 51 patients with an interpretable transperineal ultrasound scan, median cervical length measurements with the transperineal and the transvaginal technique were, respectively, 25 mm (0-53) and 27 mm (4-51). Concordance was good with an ICC of 0.83 [IC 95 % = (0.73-0.90)]. Transperineal ultrasonography was preferred in 56.5 % of cases. CONCLUSION: In case of preterm labor, cervical length measurement with transperineal ultrasonography seems reproducible and can be performed by the obstetric team on duty.