Baron Antoine Dubois and the difficult childbirth of Napoleon I's second wife the Empress Marie Louise on 20 March 1811.

BACKGROUND: History has paid little attention to the childbirth of Marie Louise, second wife to the Emperor Napoleon I. Most historians state that the obstetrician Antoine Dubois needed to use his forceps during a difficult breech delivery. As practicing obstetricians we aimed to reconstruct the likely course of events using a forensic approach. METHODS: We have consulted historical documents and key witness accounts as primary sources. We have followed the clinical guidance of the 1807 edition of 'l'Art des Accouchemens'. We have tested a new hypothesis of the possible course of the childbirth through a simulation using the Assisted Vaginal Birth Module PROMPT Flex CDE® as an obstetrical model and an authentic Levret forceps. DISCUSSION: A transverse lie with hip presentation is the most plausible diagnosis of the foetal malposition that complicated the delivery of Marie Louise by Antoine Dubois. The long duration of the delivery of the entrapped foetal head and the insistence on the presence of his colleague Corvisart by Antoine Dubois can be explained through our hypothesis that the occiput of the entrapped foetal head was very likely in a transverse position. The seemingly impossible application of a forceps in this position, had already been described in the nineteenth century both in France and outside. CONCLUSION: Our simulation confirmed the practicability of the application of the forceps as assumed by our hypothesis. Definitive proof that this scenario actually happened, cannot be given because there are no written first-hand accounts by Dubois on the delivery.

VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy.

INTRODUCTION: Hysterectomy is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal hysterectomy. Hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). METHODS: Multicentre pragmatic RCT aiming to recruit 1000 women aged 18-75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH is considered safe and feasible, the patient will be randomised within group A (VH vs vNOTES). If VH is not considered safe or feasible, patients will be randomised within group B (LH vs vNOTES). ANALYSIS: Primary outcome is the proportion of women leaving the hospital within 12 hours after surgery. Secondary outcomes are hospitalisation time, conversion rates, duration of the surgical procedure, intraoperative complications, postoperative complications and readmission. ETHICS AND DISSEMINATION: The Ethical Board Committee at Imelda Hospital, Bonheiden, Belgium, has approved the research protocol 230704 (principal investigator). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05971875.

vNOTES retroperitoneal transient uterine artery occlusion: a new approach to control bleeding during a high-risk evacuation of products of conception.

OBJECTIVE: To describe a retroperitoneal transient occlusion of the uterine or internal iliac artery in conjunction with a high-risk evacuation of products of conception. The procedure was performed vaginally, minimally invasively, via vaginal natural orifice transluminal endoscopic surgery. DESIGN: Description of the surgical technique using original video footage. This study was exempted from requiring hospital institutional review board approval. SETTING: Teaching hospital. PATIENT(S): A 34-year-old woman (G8P3) with a medical history of 2 cesarean sections, 1 partial mole, and a missed abortion with 2.8 L of blood loss. The patient presented after 10 weeks of amenorrhea. Ultrasound revealed a large blood-filled niche in the cesarean section scar with a thin overlying myometrium. A partial mole was suspected as well as increased vascularization in the myometrium and enhanced myometrial vascularity with arterial flow velocities of 100 cm/s. A risk of heavy blood loss in conjunction with curettage was anticipated. The patient had a strong preference for a fertility-preserving treatment, and after informed consent, she opted for transient occlusion of the uterine arteries with subsequent suction evacuation of the molar pregnancy. The patient signed a consent form accepting the procedure. The patient included in this video provided consent for publication of the video and posting of the video online including social media, the journal website, and scientific literature websites. Institutional review board approval was not required in accordance with the IDEAL guidelines. INTERVENTION(S): A vaginal incision was made over the bladder, and the vaginal mucosa was dissected. The paravesical space was dissected over the arcus tendinous, and the pelvic retroperitoneal space was opened. A small (7 cm) GelPOINT V-Path (Applied Medical, Rancho Santa Margarita, California) was inserted into the obturator fossa and insufflated with 10 CO2 mm Hg. Standard laparoscopic instruments were used through the gel port. Under endoscopic view, dissection to the right obturator fossa and iliac vessels was made, and the internal iliac artery was identified. A removable clip was placed on the origin of the right uterine artery. The same procedure was performed on the left side where the internal iliac artery was clipped. Different vessels were clipped to demonstrate and investigate the feasibility of both approaches. Both vessels were equally accessible. Care should be taken not to injure the uterine vein at the time of clipping. Dilation and evacuation was performed under transanal ultrasound surveillance. When hemostatic control was assured, first, the right clip was removed from the iliac artery. Hemostatic control was ensured, and after 10 minutes, the second clip on the left iliac artery was removed. The GelPOINT was removed, and the vaginal incision was sutured. The patient bled in total 500 mL. MAIN OUTCOME MEASURE(S): Not applicable. RESULT(S): The patient recovered swiftly without complications. Pathology confirmed a partial molar pregnancy. CONCLUSION(S): Uterine or internal iliac artery ligation can be lifesaving in situations with massive bleeding from the uterus. Current minimally invasive approaches are laparoscopic vessel ligation and, more commonly, uterine artery embolization, which has unclear impact on fertility and has shown an increased risk of intrauterine growth restriction, miscarriage, and prematurity. As the patient was undergoing a vaginal evacuation of pregnancy, a vaginal and retroperitoneal approach of artery ligation was deemed least invasive. In patients with fertility-preserving wishes, care should to be taken to avoid as much trauma as possible to the endometrium. Optimized blood control, and a shorter duration of using a curette, may potentially reduce the risk of endometrial damage. We present a novel minimally invasive approach via vaginal natural orifice transluminal endoscopic surgery-retroperitoneal transient occlusion of the internal iliac or uterine artery. The whole procedure can be performed by the operating gynecologist, and the occlusion is transient and can be reversed in a stepwise controlled manner.

Standardized 10-step approach for successfully performing a hysterectomy via vaginal natural orifice transluminal endoscopic surgery.

Vaginal natural orifice transluminal endoscopic surgery (NOTES) is a novel technique for minimally invasive gynecological surgery. Adequate training and standardization are key elements to patient safety and quality of care. Based on consensus statements and expert opinion; we report a step-by-step guidance for hysterectomy via natural orifice transluminal endoscopy. A detailed description is presented of pre- and postoperative care, and the instruments and equipment used, and surgical steps are illustrated by photographic images. This report can guide surgeons in their training to perform a hysterectomy via NOTES.

Predictors for sexual dysfunction in the first year postpartum: A systematic review and meta-analysis.

BACKGROUND: Pregnancy and childbirth increase the risk for pelvic floor dysfunction, including sexual dysfunction. So far, the mechanisms and the extent to which certain risk factors play a role remain unclear. OBJECTIVES: In this systematic review of the literature we aimed to determine risk factors for sexual dysfunction in the first year after childbirth. SEARCH STRATEGY: We searched MEDLINE, Embase and CENTRAL using the search strategy: sexual dysfunction AND obstetric events. SELECTION CRITERIA: We included original, comparative studies, reported in English, that used validated questionnaires and the ICS/IUGA terminology for sexual dysfunction, dyspareunia and vaginal dryness. DATA COLLECTION AND ANALYSIS: We assessed the quality and the risk of bias of the included studies with the Newcastle-Ottawa scale. We extracted the reported data and we performed random-effects meta-analysis to obtain the summary odds ratios (ORs) with 95% confidence intervals (95% CIs). Heterogeneity across studies was assessed using the I2 statistic. MAIN RESULTS: Anal sphincter injury was associated with increased odds for both sexual dysfunction (OR 3.00, 95%CI 1.28-7.03) and dyspareunia (OR 1.92, 95% CI 1.47-2.52). Episiotomy was associated with dyspareunia (OR 1.64, 95% CI 1.25-2.14), but not with sexual dysfunction (OR 1.90, 95% CI 0.94-3.84). Compared with spontaneous birth, caesarean section reduced the odds for dyspareunia (OR 0.68, 95% CI 0.54-0.86) but not for sexual dysfunction (OR 1.14, 95% CI 0.89-1.46). Instrumental vaginal birth increased the odds for sexual dysfunction (OR 1.70, 95% CI 1.05-2.76), yet no difference was found for dyspareunia (OR 1.82, 95% CI 0.88-3.75). One study of low quality reported on vaginal dryness and found no association with obstetric events. CONCLUSIONS: Perineal trauma, rather than mode of birth, increases the odds for sexual dysfunction in the first year after childbirth. TWEETABLE ABSTRACT: Perineal trauma, rather than mode of birth, correlates with sexual dysfunction and dyspareunia postpartum. #dyspareunia #OASI #episiotomy.

Pregnancy Outcome after Vaginal Natural Orifice Transluminal Endoscopic Surgery, a First Retrospective Observational Cohort Study.

STUDY OBJECTIVE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimal invasive surgical technique allowing a variety of gynecological procedures. The current literature describes improved patient comfort, improved better cosmetic results, and reduced operation time. This is a first study to assess pregnancy outcome after fertility-preserving vNOTES procedures. Design/Participants/Materials/Setting/Methods: We performed a retrospective observational cohort study including 125 patients under 43 years that underwent fertility-preserving vNOTES over a 5-year period (2014-2019). The gynecological surgical procedures included were vNOTES myomectomy, vNOTES salpingectomy for ectopic pregnancy, vNOTES unilateral adnexectomy, and vNOTES cystectomy. A total of 26 pregnancies in 21 cases were observed, with deliveries between 2015 and 2020. RESULTS: Retrospective analysis in this patient group showed that 18 pregnancies were diagnosed within 1 year after vNOTES (85.7%). Mean interval between surgery and pregnancy was 6 months. Fertility treatment was performed in 28.6%. In the 26 observed pregnancies, no vNOTES-related complications were observed and delivery was at term in all cases. Mode of delivery was a vaginal delivery in twenty cases (76.9% of total) of which 2 cases vacuum assisted (7.7%) and a Caesarean section in 6 cases (23.1% of total). Two cases of trial of labor after Caesarean are described after vNOTES surgery, both ended in an uncomplicated vaginal delivery. In case of vaginal delivery, the perineum was intact in 15%, a mediolateral episiotomy was performed in 50 and 35% a grade 1-2 perineal rupture was described. No grade 3-4 perineal ruptures are described. LIMITATIONS: A limitation of this study is the retrospective design which does not correct for confounding factors. Further larger multicenter studies are needed to validate these data. CONCLUSIONS: This is the first study describing pregnancy outcome after fertility-preserving vNOTES procedures. vNOTES did not affect the mode of delivery or cause pregnancy-related complications. vNOTES did not increase the risk of extensive perineal tears during vaginal delivery. These preliminary data show no adverse events when vNOTES is performed in women of reproductive age. Posterior colpotomy as performed in all vNOTES procedures is by itself not an indication for an elective Caesarean section.

Obstetric risk factors for anorectal dysfunction after delivery: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Pregnancy and childbirth are considered risk factors for pelvic floor dysfunction, including anorectal dysfunction. We aimed to assess the effect of obstetric events on anal incontinence and constipation after delivery. METHODS: We systematically reviewed the literature by searching MEDLINE, Embase and CENTRAL. We included studies in women after childbirth examining the association between obstetric events and anorectal dysfunction assessed through validated questionnaires. We selected eligible studies and clustered the data according to the type of dysfunction, obstetric event and interval from delivery. We assessed risk of bias using the Newcastle Ottawa Scale and we performed a random-effects meta-analysis and reported the results as odds ratios (ORs) with their 95% confidence intervals. Heterogeneity across studies was assessed using I2 statistics. RESULTS: Anal sphincter injury (OR: 2.44 [1.92-3.09]) and operative delivery were risk factors for anal incontinence (forceps-OR :1.35 [1.12-1.63]; vacuum-OR: 1.17 [1.04-1.31]). Spontaneous vaginal delivery increased the risk of anal incontinence compared with caesarean section (OR: 1.27 [1.07-1.50]). Maternal obesity (OR:1.48 [1.28-1.72]) and advanced maternal age (OR: 1.56 [1.30-1.88]) were risk factors for anal incontinence. The evidence on incontinence is of low certainty owing to the observational nature of the studies. No evidence was retrieved regarding constipation after delivery because of a lack of standardised validated assessment tools. CONCLUSIONS: Besides anal sphincter injury, forceps delivery, maternal obesity and advanced age were associated with higher odds of anal incontinence, whereas caesarean section is protective. We could not identify obstetric risk factors for postpartum constipation, as few prospective studies addressed this question and none used a standardised validated questionnaire.

Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia.

BACKGROUND: Congenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehensive assessment of severity is possible, allowing for in utero referral to an experienced centre for planned delivery. In an effort to improve outcomes, prenatal interventions to stimulate lung development were proposed. Along the same lines, new postnatal management strategies are being developed. In order to enable proper comparison of novel perinatal interventions as well as outcomes, a set of uniform and relevant outcome measures is required. Core outcome sets (COS) are agreed, clearly defined sets of outcomes to be measured in a standardised manner and reported consistently. Herein we aim to describe the methodology we will use to define a COS for perinatal and neonatal outcomes of foetuses and newborns with congenital diaphragmatic hernia and to draft a dissemination and implementation plan. METHODS: We will use the methodology described in the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Handbook. An international steering group will be created to guide the development of the COS. We are systematically reviewing the literature to identify all potential relevant pre- and neonatal outcomes previously used in studies on perinatal interventions for CDH. We will build a consensus on these core outcomes in a stakeholder group using the Delphi method. After completion, a stakeholder meeting will decide on a final COS, using a modified Nominal Group Technique. Thereafter, we will review potential definitions and measurements of these outcomes, and again a consensus meeting will be organised, to finalise the COS before dissemination. DISCUSSION: We have started a procedure to develop a COS for studies on perinatal interventions for congenital diaphragmatic hernia, with the purpose of improving the quality of research, guide clinical practice and improve patient care and eventual use in future clinical trials, systematic reviews and clinical practice guidelines. TRIAL REGISTRATION: We prospectively registered this study in the International Prospective Register of Systematic Reviews (PROSPERO) (registration number: CRD42019124399 ) and The Core Outcome Measures in Effectiveness Trials (COMET) Initiative (registration number: 1296 ).

Preclinical stem cell therapy in fetuses with myelomeningocele: A systematic review and meta-analysis.

OBJECTIVE: We performed a systematic review to summarize the efficacy and safety of in utero stem cells application in preclinical models with myelomeningocele (MMC). METHODS: The study was registered with PROSPERO (CRD42019160399). We searched MEDLINE, Embase, Web of Science, Scopus and CENTRAL for publications articles on stem cell therapy in animal fetuses with MMC until May 2020. Publication quality was assessed by the SYRCLE's tool. Meta-analyses were pooled if studies were done in the same animal model providing similar type of stem cell used and outcome measurements. Narrative synthesis was performed for studies that could not be pooled. RESULTS: Nineteen and seven studies were included in narrative and quantitative syntheses, respectively. Most used mesenchymal stem cells (MSCs) and primarily involved ovine and rodent models. Both intra-amniotic injection of allogeneic amniotic fluid (AF)-MSCs in rat MMC model and the application of human placental (P)-MSCs to the spinal cord during fetal surgery in MMC ovine model did not compromise fetal survival rates at term (rat model, relative risk [RR] 1.03, 95% CI 0.92-1.16; ovine model, RR 0.94, 95% CI 0.78-1.13). A single intra-amniotic injection of allogeneic AF-MSCs into rat MMC model was associated with a higher rate of complete defect coverage compared to saline injection (RR 16.35, 95% CI 3.27-81.79). The incorporation of human P-MSCs as a therapeutic adjunct to fetal surgery in the ovine MMC model significantly improved sheep locomotor rating scale after birth (mean difference 5.18, 95% CI 3.36-6.99). CONCLUSIONS: Stem cell application during prenatal period in preclinical animal models is safe and effective.

vNOTES Hysterectomy for Large Uteri: A Retrospective Cohort Study of 114 Patients.

STUDY OBJECTIVE: To evaluate the outcome of hysterectomy through vaginal natural orifice transluminal endoscopic surgery (vNOTES) in cases with a large uterus. DESIGN: A retrospective cohort study. SETTING: Belgian teaching hospital. PATIENTS: Women who underwent a vNOTES hysterectomy from March 2015 to March 2020 for benign gynecologic disease with a uterine weight of 280 g or more on pathologic examination (N = 114). INTERVENTIONS: All women underwent vaginally assisted NOTES hysterectomy. We performed a retrospective analysis of baseline patient characteristics and clinical outcomes. MEASUREMENTS AND MAIN RESULTS: The mean age was 50 ± 3.5 years. Twenty-two (19%) patients were obese (body mass index ≥30 kg/m2), and 4 (3.5%) were morbidly obese (body mass index ≥40 kg/m2). Thirty-five (31%) patients were nulliparous, and 15 (13%) women had 1 or more cesarean sections in their medical history. Uterine weight varied from 281 g to 3361 g, with a mean weight of 559 ± 425 g. Mean surgical time was 63 ± 34 minutes. Surgical time was positively associated with uterine size. There were 4 complications: 3 bleeding complications in the first 24 hours after surgery and 1 minor late complication. Conversion to laparotomy for specimen extraction was performed in 1 case (conversion rate 0.9%). There were no conversions to laparoscopy. No ureteric, bladder, or intestinal injuries occurred in this case series, and there were neither life-threatening complications nor intensive care unit admissions. CONCLUSION: The vNOTES technique can offer a safe and effective alternative to laparoscopy or laparotomy in cases with a large to very large uterus, even if the patient has a history of cesarean section, obesity, or nulliparity. In 99% of all women in this study, hysterectomy was successfully performed through vNOTES without conversion. By making use of the advantages of endoscopic surgery, vNOTES might broaden the indications of vaginal hysterectomy. Randomized controlled trials are needed to evaluate whether vaginally assisted NOTES hysterectomy is superior to laparoscopic or abdominal hysterectomy in large uteri cases.

Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications.

(1) Objective: We aimed to report an update of the systematic review and meta-analysis by Baekelandt et al. (2016). (2) Method: We followed PRISMA guidelines to perform this systematic review. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. (3) Results: Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra- and postoperative complications, readmission, pain scores at 24 h postoperative and change in hemoglobin (Hb) on day 1 postoperative.

Does Laparoscopy and Hysteroscopy Have a Place in the Diagnosis of Unexplained Infertility?

The standard fertility workup includes assessment of ovulation, semen analysis, and evaluation of tubal patency. If the fertility workup is found to be normal, a diagnosis of unexplained infertility is made. The role of laparoscopy in fertility workup has been a matter of debate. The current review presents the evidence for and against laparoscopy and hysteroscopy during fertility workup and subsequently prior to fertility treatment. After appraising the literature, we found the role of diagnostic laparoscopy in fertility workup is limited and is dependent on factors like prevalence of pelvic infection, setting, and availability of expertise. Moreover, whenever a laparoscopy is planned as a part of the fertility workup, the preparation should include ability to carry out simultaneous therapeutic intervention to maximize the benefit. Similarly, the routine use of hysteroscopy in women with unexplained infertility cannot be recommended. There is a need to investigate the impact of choice of tubal test on chances of spontaneous conception and treatment outcomes in women with unexplained infertility. Our future research agenda should also include high-quality multicenter randomized trials assessing the cost-effectiveness of screening and operative hysteroscopy prior to intrauterine insemination or in vitro fertilization.

Laparoscopic surgery for endometriosis.

BACKGROUND: Endometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. OBJECTIVES: To assess the effectiveness and safety of laparoscopic surgery in the treatment of pain and infertility associated with endometriosis. SEARCH METHODS: This review has drawn on the search strategy developed by the Cochrane Gynaecology and Fertility Group including searching the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, reference lists for relevant trials, and trial registries from inception to April 2020. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) that compared the effectiveness and safety of laparoscopic surgery with any other laparoscopic or robotic intervention, holistic or medical treatment, or diagnostic laparoscopy only. DATA COLLECTION AND ANALYSIS: Two review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data with disagreements resolved by a third review author. We collected data for the core outcome set for endometriosis. Primary outcomes included overall pain and live birth. We evaluated the quality of evidence using GRADE methods. MAIN RESULTS: We included 14 RCTs. The studies randomised 1563 women with endometriosis. Four RCTs compared laparoscopic ablation or excision with diagnostic laparoscopy only. Two RCTs compared laparoscopic excision with diagnostic laparoscopy only. One RCT compared laparoscopic ablation or excision with laparoscopic ablation or excision and uterine suspension. Two RCTs compared laparoscopic ablation and uterine nerve transection with diagnostic laparoscopy only. One RCT compared laparoscopic ablation with diagnostic laparoscopy and gonadotropin-releasing hormone (GnRH) analogues. Two RCTs compared laparoscopic ablation with laparoscopic excision. One RCT compared laparoscopic ablation or excision with helium thermal coagulator with laparoscopic ablation or excision with electrodiathermy. One RCT compared conservative laparoscopic surgery with laparoscopic colorectal resection of deep endometriosis infiltrating the rectum. Common limitations in the primary studies included lack of clearly described blinding, failure to fully describe methods of randomisation and allocation concealment, and poor reporting of outcome data. Laparoscopic treatment versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic treatment on overall pain scores compared to diagnostic laparoscopy only at six months (mean difference (MD) 0.90, 95% confidence interval (CI) 0.31 to 1.49; 1 RCT, 16 participants; very low quality evidence) and at 12 months (MD 1.65, 95% CI 1.11 to 2.19; 1 RCT, 16 participants; very low quality evidence), where a positive value means pain relief (the higher the score, the more pain relief) and a negative value reflects pain increase (the lower the score, the worse the increase in pain). No studies looked at live birth. We are uncertain of the effect of laparoscopic treatment on quality of life compared to diagnostic laparoscopy only: EuroQol-5D index summary at six months (MD 0.03, 95% CI -0.12 to 0.18; 1 RCT, 39 participants; low quality evidence), 12-item Short Form (SF-12) mental health component (MD 2.30, 95% CI -4.50 to 9.10; 1 RCT, 39 participants; low quality evidence) and SF-12 physical health component (MD 2.70, 95% CI -2.90 to 8.30; 1 RCT, 39 participants; low quality evidence). Laparoscopic treatment probably improves viable intrauterine pregnancy rate compared to diagnostic laparoscopy only (odds ratio (OR) 1.89, 95% CI 1.25 to 2.86; 3 RCTs, 528 participants; I2 = 0%; moderate quality evidence). We are uncertain of the effect of laparoscopic treatment compared to diagnostic laparoscopy only on ectopic pregnancy (MD 1.18, 95% CI 0.10 to 13.48; 1 RCT, 100 participants; low quality evidence) and miscarriage (MD 0.94, 95% CI 0.35 to 2.54; 2 RCTs, 112 participants; low quality evidence). There was limited reporting of adverse events. No conversions to laparotomy were reported in both groups (1 RCT, 341 participants). Laparoscopic ablation and uterine nerve transection versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic ablation and uterine nerve transection on adverse events (more specifically vascular injury) compared to diagnostic laparoscopy only (OR 0.33, 95% CI 0.01 to 8.32; 1 RCT, 141 participants; low quality evidence). No studies looked at overall pain scores (at six and 12 months), live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage. Laparoscopic ablation versus laparoscopic excision There was insufficient evidence to determine whether there was a difference in overall pain, measured at 12 months, for laparoscopic ablation compared with laparoscopic excision (MD 0.00, 95% CI -1.22 to 1.22; 1 RCT, 103 participants; very low quality evidence). No studies looked at overall pain scores at six months, live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy, miscarriage and adverse events. Helium thermal coagulator versus electrodiathermy We are uncertain whether helium thermal coagulator compared to electrodiathermy improves quality of life using the 30-item Endometriosis Health Profile (EHP-30) at nine months, when considering the components: pain (MD 6.68, 95% CI -3.07 to 16.43; 1 RCT, 119 participants; very low quality evidence), control and powerlessness (MD 4.79, 95% CI -6.92 to 16.50; 1 RCT, 119 participants; very low quality evidence), emotional well-being (MD 6.17, 95% CI -3.95 to 16.29; 1 RCT, 119 participants; very low quality evidence) and social support (MD 5.62, 95% CI -6.21 to 17.45; 1 RCT, 119 participants; very low quality evidence). Adverse events were not estimable. No studies looked at overall pain scores (at six and 12 months), live birth, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage. AUTHORS' CONCLUSIONS: Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. No data were reported on live birth. There is moderate quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only. No studies were found that looked at live birth for any of the comparisons. Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.

Effects of non-ablative Er:YAG laser on the skin and the vaginal wall: systematic review of the clinical and experimental literature.

INTRODUCTION AND HYPOTHESIS: Er:YAG laser is frequently used in dermatology and gynecology. Clinical studies document high satisfaction rates; however, hard data on the effects at the structural and molecular levels are limited. The aim of this systematic review was to summarize current knowledge about the objective effects of non-ablative Er:YAG laser on the skin and vaginal wall. METHODS: We searched MEDLINE, Embase, Cochrane, and the Web of Science. Studies investigating objectively measured effects of non-ablative Er:YAG laser on the skin or vaginal wall were included. Studies of any design were included. Owing to the lack of methodological uniformity, no meta-analysis could be performed and therefore results are presented as a narrative review. RESULTS: We identified in vitro or ex vivo studies on human cells or tissues, studies in rats, and clinical studies. Most studies were on the skin (n = 11); the rest were on the vagina (n = 4). The quality of studies is limited and the settings of the laser were very diverse. Although the methods used were not comparable, there were demonstrable effects in all studies. Immediately after application the increase in superficial temperature, partial preservation of epithelium and subepithelial extracellular matrix coagulation were documented. Later, an increase in epithelial thickness, inflammatory response, fibroblast proliferation, an increase in the amount of collagen, and vascularization were described. CONCLUSIONS: Er:YAG laser energy may induce changes in the deeper skin or vaginal wall, without causing unwanted epithelial ablation. Laser energy initiates a process of cell activation, production of extracellular matrix, and tissue remodeling.

The Risk for Glucose Intolerance after Gestational Diabetes Mellitus since the Introduction of the IADPSG Criteria: A Systematic Review and Meta-Analysis.

The aim of the study was to assess the postpartum risk for glucose intolerance since the introduction of the 'International Association of Diabetes and Pregnancy Study Groups' (IADPSG) criteria for gestational diabetes mellitus (GDM). Studies published since 2010 were included, which evaluated the risk for type 2 diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and cardiovascular (CV) events in women with previous GDM compared to normal glucose tolerant women. We included forty-three studies, evaluating 4,923,571 pregnant women of which 5.8% (284,312) had a history of GDM. Five studies used IADPSG criteria (n = 6174 women, 1314 with GDM). The overall pooled relative risk (RR) for postpartum T2DM was 7.42 (95% CI: 5.99-9.19) and the RR for postpartum T2DM with IADPSG criteria was 6.45 (95% CI: 4.74-8.77) compared to the RR of 9.08 (95% CI: 6.96-11.85; p = 0.17) for postpartum T2DM based on other diagnostic criteria. The RR for postpartum IGT was 2.45 (95% CI: 1.92-3.13), independent of the criteria used. None of the available studies with IADPSG criteria evaluated the risk for CV events. Women with a history of GDM based on the IADPSG criteria have a similarly increased risk for postpartum glucose intolerance compared to GDM based on other diagnostic criteria. More studies with GDM based on the IADPSG criteria are needed to increase the quality of evidence concerning the long-term metabolic risk.

Screening hysteroscopy in subfertile women and women undergoing assisted reproduction.

BACKGROUND: Screening hysteroscopy in infertile women with unexplained infertility, or prior to intrauterine insemination (IUI) or in vitro fertilisation (IVF) may reveal intrauterine pathology that may not be detected by routine transvaginal ultrasound. Hysteroscopy, whether purely diagnostic or operative may improve reproductive outcomes. OBJECTIVES: To assess the effectiveness and safety of screening hysteroscopy in subfertile women undergoing evaluation for infertility, and subfertile women undergoing IUI or IVF. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL CRSO, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (September 2018). We searched reference lists of relevant articles and handsearched relevant conference proceedings. SELECTION CRITERIA: Randomised controlled trials comparing screening hysteroscopy versus no intervention in subfertile women wishing to conceive spontaneously, or before undergoing IUI or IVF. DATA COLLECTION AND ANALYSIS: We independently screened studies, extracted data, and assessed the risk of bias. The primary outcomes were live birth rate and complications following hysteroscopy. We analysed data using risk ratio (RR) and a fixed-effect model. We assessed the quality of the evidence by using GRADE criteria. MAIN RESULTS: We retrieved 11 studies. We included one trial that evaluated screening hysteroscopy versus no hysteroscopy, in women with unexplained subfertility, who were trying to conceive spontaneously. We are uncertain whether ongoing pregnancy rate improves following a screening hysteroscopy in women with at least two years of unexplained subfertility (RR 4.30, 95% CI 2.29 to 8.07; 1 RCT; participants = 200; very low-quality evidence). For a typical clinic with a 10% ongoing pregnancy rate without hysteroscopy, performing a screening hysteroscopy would be expected to result in ongoing pregnancy rates between 23% and 81%. The included study reported no adverse events in either treatment arm. We are uncertain whether clinical pregnancy rate is improved (RR 3.80, 95% CI 2.31 to 6.24; 1 RCT; participants = 200; very low-quality evidence), or miscarriage rate increases (RR 2.80, 95% CI 1.05 to 7.48; 1 RCT; participants = 200; very low-quality evidence), following screening hysteroscopy in women with at least two years of unexplained subfertility.We included ten trials that included 1836 women who had a screening hysteroscopy and 1914 women who had no hysteroscopy prior to IVF. Main limitations in the quality of evidence were inadequate reporting of study methods and higher statistical heterogeneity. Eight of the ten trials had unclear risk of bias for allocation concealment.Performing a screening hysteroscopy before IVF may increase live birth rate (RR 1.26, 95% CI 1.11 to 1.43; 6 RCTs; participants = 2745; I² = 69 %; low-quality evidence). For a typical clinic with a 22% live birth rate, performing a screening hysteroscopy would be expected to result in live birth rates between 25% and 32%. However, sensitivity analysis done by pooling results from trials at low risk of bias showed no increase in live birth rate following a screening hysteroscopy (RR 0.99, 95% CI 0.82 to 1.18; 2 RCTs; participants = 1452; I² = 0%).Only four trials reported complications following hysteroscopy; of these, three trials recorded no events in either group. We are uncertain whether a screening hysteroscopy is associated with higher adverse events (Peto odds ratio 7.47, 95% CI 0.15 to 376.42; 4 RCTs; participants = 1872; I² = not applicable; very low-quality evidence).Performing a screening hysteroscopy before IVF may increase clinical pregnancy rate (RR 1.32, 95% CI 1.20 to 1.45; 10 RCTs; participants = 3750; I² = 49%; low-quality evidence). For a typical clinic with a 28% clinical pregnancy rate, performing a screening hysteroscopy would be expected to result in clinical pregnancy rates between 33% and 40%.There may be little or no difference in miscarriage rate following screening hysteroscopy (RR 1.01, 95% CI 0.67 to 1.50; 3 RCTs; participants = 1669; I² = 0%; low-quality evidence).We found no trials that compared a screening hysteroscopy versus no hysteroscopy before IUI. AUTHORS' CONCLUSIONS: At present, there is no high-quality evidence to support the routine use of hysteroscopy as a screening tool in the general population of subfertile women with a normal ultrasound or hysterosalpingogram in the basic fertility work-up for improving reproductive success rates.In women undergoing IVF, low-quality evidence, including all of the studies reporting these outcomes, suggests that performing a screening hysteroscopy before IVF may increase live birth and clinical pregnancy rates. However, pooled results from the only two trials with a low risk of bias did not show a benefit of screening hysteroscopy before IVF.Since the studies showing an effect are those with unclear allocation concealment, we are uncertain whether a routine screening hysteroscopy increases live birth and clinical pregnancy, be it for all women, or those with two or more failed IVF attempts. There is insufficient data to draw conclusions about the safety of screening hysteroscopy.

Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities.

BACKGROUND: Observational studies suggest higher pregnancy rates after the hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum or intrauterine adhesions, which are present in 10% to 15% of women seeking treatment for subfertility. OBJECTIVES: To assess the effects of the hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum or intrauterine adhesions suspected on ultrasound, hysterosalpingography, diagnostic hysteroscopy or any combination of these methods in women with otherwise unexplained subfertility or prior to intrauterine insemination (IUI), in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). SEARCH METHODS: We searched the following databases from their inception to 16 April 2018; The Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Studies Online, ; MEDLINE, Embase , CINAHL , and other electronic sources of trials including trial registers, sources of unpublished literature, and reference lists. We handsearched the American Society for Reproductive Medicine (ASRM) conference abstracts and proceedings (from 1 January 2014 to 12 May 2018) and we contacted experts in the field. SELECTION CRITERIA: Randomised comparison between operative hysteroscopy versus control for unexplained subfertility associated with suspected major uterine cavity abnormalities.Randomised comparison between operative hysteroscopy versus control for suspected major uterine cavity abnormalities prior to medically assisted reproduction.Primary outcomes were live birth and hysteroscopy complications. Secondary outcomes were pregnancy and miscarriage. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and risk of bias, and extracted data. We contacted study authors for additional information. MAIN RESULTS: Two studies met the inclusion criteria.1. Randomised comparison between operative hysteroscopy versus control for unexplained subfertility associated with suspected major uterine cavity abnormalities.In women with otherwise unexplained subfertility and submucous fibroids, we were uncertain whether hysteroscopic myomectomy improved the clinical pregnancy rate compared to expectant management (odds ratio (OR) 2.44, 95% confidence interval (CI) 0.97 to 6.17; P = 0.06, 94 women; very low-quality evidence). We are uncertain whether hysteroscopic myomectomy improves the miscarriage rate compared to expectant management (OR 1.54, 95% CI 0.47 to 5.00; P = 0.47, 94 women; very low-quality evidence). We found no data on live birth or hysteroscopy complication rates. We found no studies in women with endometrial polyps, intrauterine adhesions or uterine septum for this randomised comparison.2. Randomised comparison between operative hysteroscopy versus control for suspected major uterine cavity abnormalities prior to medically assisted reproduction.The hysteroscopic removal of polyps prior to IUI may have improved the clinical pregnancy rate compared to diagnostic hysteroscopy only: if 28% of women achieved a clinical pregnancy without polyp removal, the evidence suggested that 63% of women (95% CI 45% to 89%) achieved a clinical pregnancy after the hysteroscopic removal of the endometrial polyps (OR 4.41, 95% CI 2.45 to 7.96; P < 0.00001, 204 women; low-quality evidence). We found no data on live birth, hysteroscopy complication or miscarriage rates in women with endometrial polyps prior to IUI. We found no studies in women with submucous fibroids, intrauterine adhesions or uterine septum prior to IUI or in women with all types of suspected uterine cavity abnormalities prior to IVF/ICSI. AUTHORS' CONCLUSIONS: Uncertainty remains concerning an important benefit with the hysteroscopic removal of submucous fibroids for improving the clinical pregnancy rates in women with otherwise unexplained subfertility. The available low-quality evidence suggests that the hysteroscopic removal of endometrial polyps suspected on ultrasound in women prior to IUI may improve the clinical pregnancy rate compared to simple diagnostic hysteroscopy. More research is needed to measure the effectiveness of the hysteroscopic treatment of suspected major uterine cavity abnormalities in women with unexplained subfertility or prior to IUI, IVF or ICSI.

Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial.

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) uses natural orifices to access the cavities of the human body to perform surgical interventions. NOTES limits the magnitude of surgical trauma and potentially reduces postoperative pain. Our group published a protocol on a randomised study comparing transvaginal NOTES (vNOTES) versus laparoscopy for hysterectomy (HALON). We simultaneously designed a similar randomised controlled trial (RCT) comparing vNOTES with laparoscopy for adnexectomy. To the best of our knowledge, this is the first RCT comparing vNOTES with laparoscopy for adnexal surgery. METHODS AND ANALYSIS: The methodology of the Notes Adnexectomy for Benign Indication versus Laparoscopic Excision (NOTABLE) study is similar to that of the HALON trial. Women aged 18-70 years with an indication for benign adnexal surgery will be eligible. We will use stratification according to adnexal size. Entrants will be randomised to the laparoscopic treatment (control) or vNOTES (intervention). Participants will be evaluated on days 0-7 and at 3 and 6 months. The primary outcome will be the proportion of women successfully treated by removing an adnexa by the allocated technique without conversion. We will collect the following data (secondary outcomes): proportion of women hospitalised on the day of surgery, postoperative pain scores measured two times per day from day 1 to 7, total dosage of pain killers used from day 1 to 7, hospital readmission during the first 6 weeks, dyspareunia and sexual well-being at baseline, 3 and 6 months using a validated questionnaire (Short Sexual Functioning Scale), health-related quality of life at baseline, 3 and 6 months after surgery using a validated questionnaire (EQ-5D-3L), duration of surgical intervention, infection or other surgical complications and direct costs up to 6 weeks following surgery. For the primary outcome measure, a one-sided 95% CI of the difference in the proportions of women with a successful removal of the uterus by the randomised technique will be estimated. Non-inferiority will be concluded when 15% lies above the upper limit of this 95% CI. ETHICS AND DISSEMINATION: The study was approved on 1 December 2015 by the EthicsCommitteeof the Imelda Hospital (registration no: 689), Bonheiden, Belgium. We aim to present the final results of the NOTABLE trial in peer-reviewed journals and at scientific meetings within 4 years after the start of the recruitment. TRIAL REGISTRATION NUMBER: NCT02630329.