From pregnancy to 3 months after birth:the beginning of mother-infant relationship from a maternal perspective.

BACKGROUND: An early positive mother-child relationship is a central factor in the development of a psychologically balanced personality. The study aims to identify risk and protective factors for the development of a balanced maternal-infant postnatal attachment. We explored the association between maternal-infant attachment and prenatal and postnatal variables potentially implicated in the development of this early bond: maternal-foetal prenatal attachment, social support, memories of parental care, romantic attachment, dyadic adjustment, parity, breastfeeding, planning pregnancy, woman's and infant's age, and difficulty of delivery. METHODS: 123 pregnant women participated in the longitudinal study; they were assessed on the MAAS, PBI, ECR-R, MSPSS (t1: pregnancy), MPAS (t2: 3-months postnatally), DAS , and CES-D (t1, t2). RESULTS: Four significant predictors of maternal-infant postnatal attachment (MPAS) emerged: maternal-foetal prenatal attachment (ß = 0.379, p < .001), anxiety in the romantic relationships (ß=-0.237, p=0.019), prenatal and postnatal dyadic adjustment (t1, ß=-0.323, p=0.025 ;t2, ß=0.329, p=0.014) in the couple's relationship. These variables explained 20.2% of variance in mother-infant attachment (R2adjusted=0.202). DISCUSSION: The study highlights associations of maternal-infant postnatal attachment with prenatal and postnatal relational variables and with other variables related to the woman's reproductive and pregnancy history. Clinical attention to these factors could help protect the well-being of mother and child.

"An unnecessary cut?" multilevel health systems analysis of drivers of caesarean sections rates in Italy: a systematic review.

BACKGROUND: Improvements in medical technologies have seen over-medicalization of childbirth. Caesarean section (CS) is a lifesaving procedure proven effective in reducing maternal and perinatal mortality across the globe. However, as with any medical procedure, the CS intrinsically carries some risk to its beneficiaries. In recent years, CS rates have risen alarmingly in high-income countries. Many exceeding the World Health Organisation (WHO) recommendation of a 10 to 15% annual CS rate. While this situation poses an increased risk to women and their children, it also represents an excess human and financial burden on health systems. Therefore, from a health system perspective this study systematically summarizes existing evidence relevant to the factors driving the phenomenon of increasing CS rates using Italy as a case study. METHODS: Employing the WHO Health System Framework (WHOHSF), this systematic review used the PRISMA guidelines to report findings. PubMed, SCOPUS, MEDLINE, Cochrane Library and Google Scholar databases were searched up until April 1, 2020. Findings were organised through the six dimensions of the WHOHSF framework: service delivery, health workforce, health system information; medical products vaccine and technologies, financing; and leadership and governance. RESULTS: CS rates in Italy are affected by complex interactions among several stakeholder groups and contextual factors such as the hyper-medicalisation of delivery, differences in policy and practice across units and the national context, issues pertaining to the legal and social environment, and women's attitudes towards pregnancy and childbirth. CONCLUSION: Mitigating the high rates of CS will require a synergistic multi-stakeholder intervention. Specifically, with processes able to attract the official endorsement of policy makers, encourage concensus between regional authorities and local governments and guide the systematic compliance of delivery units with its clinical guidelines.

Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data.

Uterine fibroids (UFs) are the most common gynaecological benign disease. Even though often asymptomatic, UFs can worsen women's health and their quality of life, causing heavy bleeding and anaemia, pelvic discomfort and reduced fertility. Surgical treatment of UFs could be limited by its invasiveness and the desire to preserve fertility. Thus, effective medical therapies for the management of this condition are needed. Common drugs used to control bleeding, such us hormonal contraceptive or levonorgestrel-releasing intrauterine system, have no effect on fibroids volume. Among other more efficient treatments, the gonadotropin-releasing hormone (GnRH) agonist or the selective progesterone-receptor modulators have a non-neutral safety profile; thus, they are used for limited periods or for cyclic treatments. Elagolix is a potent, orally bioavailable, non-peptide GnRH antagonist that acts by a competitive block of the GnRH receptor. The biological effect is a dose-dependent inhibition of gonadal axis, without a total suppression of estradiol concentrations. For this reason, even though comparative studies between elagolix and GnRH agonists have not been performed, elagolix has been associated with a better profile of adverse events. Recently, elagolix received US FDA approval for the treatment of moderate to severe pain caused by endometriosis. Several clinical trials assessed the efficacy of elagolix for the treatment of heavy bleeding caused by UFs and the definitive results of Phase III studies are expected. Available data on elagolix and UFs showed that the drug, with or without low-dose hormone add-back therapy, is able to significantly reduce menstrual blood loss, lead to amenorrhea and improve haemoglobin concentrations in the majority of participants in comparison with placebo. The safety and tolerability profile appeared generally acceptable. The concomitant use of add-back therapy can prevent bone loss due to the hypoestrogenic effect and can improve safety during elagolix treatment.

Sentinel lymph node biopsy with cervical injection of indocyanine green in apparent early-stage endometrial cancer: predictors of unsuccessful mapping.

OBJECTIVE: To identify predictors of unsuccessful sentinel lymph node (SLN) mapping in patients with apparent early-stage endometrial cancer (EC) undergoing surgical staging with cervical injection of indocyanine green and SLN biopsy. METHODS: We retrospectively identified consecutive patients with EC with attempted SLN biopsy between June 2014 and June 2016 at our institution. Patients were grouped according to whether they had a successful procedure, defined as the bilateral identification of SLNs, or an unsuccessful procedure, defined as unilateral or no SLN mapping. Logistic regression was used to evaluate predictors of an unsuccessful procedure. RESULTS: Among 327 patients included in the analysis, 256 (78.3%) had a successful procedure and 71 (21.7%) had an unsuccessful procedure (15.0% unilateral SLN mapping, 6.7% no mapping). The rate of successful procedure increased from 57.7% to 83.3% between the first and last quarters of the 2-year study period, which represented the learning curve for the technique. The mean (SD) operative time decreased from 164 (55) to 137 (37) minutes. By multivariable analysis, lysis of adhesions at the beginning of surgery (odds ratio, 3.07; 95% CI, 1.56-6.07) and the presence of enlarged lymph nodes (odds ratio, 4.69; 95% CI, 1.82-12.11) were independently associated with an unsuccessful procedure. CONCLUSIONS: Lysis of adhesions at the beginning of surgery and the presence of enlarged lymph nodes independently affect the bilateral detection of SLNs.

Systemic therapy for the treatment of endometrial cancer.

Introduction: Endometrial cancer (EC) is one of the most frequent gynecological cancers worldwide. The gold standard treatment of EC is most certainly surgery and may very well be the only therapy in the early stages of disease. To improve outcomes in non-early EC, adjuvant therapy is often employed but this is not standardized. Adjuvant options can include radiotherapy, chemotherapy or a combination of both. Adjuvant chemotherapy could be indicated in high-risk stage I and II or advanced stage EC. Several clinical trials are ongoing in an attempt to define the optimal adjuvant treatment. Furthermore, chemotherapy is the front-line therapy in advanced unresectable, metastatic or recurrent endometrial cancer. Areas covered: Herein, the authors review the first-line chemotherapy for the treatment of endometrial cancer and provide their expert perspectives on these therapies. Expert opinion: Chemotherapy is fundamental in advanced/recurrent EC. Further evidence is needed to characterize the role of adjuvant chemotherapy. Future studies should consider genomic and molecular heterogeneities to identify even more efficient tailored therapies.

Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health.

This observational study was conducted in premenopausal women who presented themselves at the Obstetrics and Gynecology Department of the University Hospital of Cagliari (Italy), for heavy menstrual bleeding (HMB) dependent on uterine myomas. After a screening visit, 19 women without contraindications to ulipristal acetate (UPA) treatment, were included in the study that envisaged 12 months of observation in which each subject was asked to assume UPA (tablet of 5 mg, ESMYA®, one tablet a day for 3 months: first cycle) two menstrual cycles of interruption and a second ESMYA® cycle, followed by 3 months of observation (third follow-up month, visit 4). The significant decrease of myoma volume, diagnosed after the first ESMYA® cycle, persisted until the visit 4. The HMB significantly decreased during the ESMYA® treatment and persisted until visit 4. The quality of life (QoL), evaluated with the questionnaire SF-36, significantly improved during the study. The values of estradiol (E2), biochemical parameters of bone metabolism, as well as those of lumbar and hip bone mineral density, did not change during the study in comparison with basal levels. The efficacy of two repeated ESMYA® cycles to treat uterine myomas and their related symptoms improves the QoL without interfering with bone health.

Prophylaxis of peripartum haemorrhage using recombinant factor VIIa (rfVIIa) in pregnant women with congenital factor VII deficiency: A case report and literature review.

Congenital factor VII deficiency is a rare autosomal recessive disorder associated to different haemorrhagic manifestations. Labour and delivery may cause bleeding risk in patients with this coagulation deficit, thus it is appropriate to clarify whether prophylaxis of peripartum haemorrhage is necessary. To date, there are very few cases in scientific literature which report the management of women with congenital factor VII deficiency during labour, and a consensus for prophylaxis does not exist. In this manuscript we present the management of a 35 years old woman with factor VII deficiency, treated with recombinant factor VIIa before delivery, without haemorrhagic complications either for the woman and for the infant. Therefore, we present a review of similar cases managed with a peripartum prophylaxis with recombinant factor VIIa, and discuss its usefulness and effectiveness, in view of the severity of the deficit and the doses used.

Does the clinical information play a role in the magnetic resonance diagnostic confidence analysis of ovarian and deep endometriosis?

OBJECTIVE:: Some recent studies have explored how the experience in the observers change their performance in the endometriosis detection using MRI but the effects of the clinical information remains uncertain. The purpose of this study was to assess the effect of the clinical information in the diagnostic confidence in the MRI diagnosis of endometriosis. METHODS AND MATERIALS:: Institutional Review Board was obtained. This study is compliant to STARD method. 80 patients (mean age 32 years; range 19 - 46 years) who had undergone MRI study and surgery for suspected endometriosis were retrospectively evaluated. MRI exams were performed with a 1.5 T scanner and the following five locations were assessed: ovary, anterior compartment, vaginal fornix, utero-sacral ligaments, and Rectum\Sigmoid\Pouch of Douglas. Data sets were evaluated twice on a 5-point scale by four radiologists with different level of expertise; the first time blinded to the clinical information and the second time, after 3 months together with the clinical chart. Statistical analysis included receiver operating characteristics curve analysis, the Cohen weighted test and sensitivity, specificity, positive predictive value, negative predictive value, accuracy, LR+ and LR-. RESULTS:: A total of 140 localization of endometriosis (47 endometriomas and 93 endometriotic nodules) were found. The pairwise comparison demonstrated that in all cases the presence of clinical information improved the Az value. The concordance analysis indicated a mixed pattern from modest agreement (weighted κ value 0.556 for anterior compartment) to excellent agreement values (weighted κ value 0.867 for ovarian endometriomas). CONCLUSION:: The results of our study suggest that clinical information is useful in diagnosing endometriosis in general anterior compartment, but not in other locations. Less experienced radiologists (resident) may benefit from it at utero-sacral ligaments or Rectum\Sigmoid\Pouch of Douglas. ADVANCES IN KNOWLEDGE:: In this era of sometimes indiscriminate use of diagnostic methods, it is important to emphasis the context for interpretation of diagnostic results. Our paper confirms that clinical information is useful in diagnosing endometriosis.

Incidence of sarcoma in patients undergoing hysterectomy for benign indications: a population-based study.

BACKGROUND: Minimally invasive hysterectomy may require the use of morcellation to remove the uterus. In the presence of unexpected sarcoma, morcellation risks disseminating malignant cells and worsening survival outcomes. As a consequence, in 2014 the US Food and Drug Administration issued a black box warning against the use of power morcellator for the treatment of uterine fibroids. However, the proportion of unexpected sarcoma at the time of hysterectomy for presumed benign indication remains unclear. OBJECTIVE: The objective of the study was to estimate the incidence of sarcoma among women undergoing hysterectomy for benign indication in Olmsted County, MN, between 1999 and 2013. STUDY DESIGN: We conducted a population-based study including all hysterectomies performed for benign indication in Olmsted County women between Jan. 1, 1999, and Dec. 31, 2013. Cases were identified using the medical records-linkage system of the Rochester Epidemiology Project, and data were abstracted by a gynecologist who reviewed the complete medical records of each woman who underwent hysterectomy. An expert pathologist reviewed the pathologic slides of each sarcoma to ensure the accuracy of the diagnosis. Incidences of sarcoma (overall and by type of sarcoma) were estimated both overall and stratified by menopausal status, indication for surgery, and uterine weight as a rate per 100 persons. RESULTS: A total of 4232 hysterectomies were performed during the study period. Among them, we identified 16 sarcomas, of which 11 (69%) were suspected preoperatively and 5 (31%) were unexpected. Of the total number of hysterectomies, 3759 (88.8%) were performed for benign indication. Among those, the incidence of unexpected sarcoma was 0.13% (5 per 3759 [95% confidence interval, 0.04-0.31%]). Uterine fibroids comprised 27.3% of all hysterectomies for benign indication (n = 1025) and was the indication most commonly associated with diagnosis of unexpected sarcoma. The incidence of unexpected sarcoma among surgeries for uterine fibroids was 0.35% (3 of 851) for premenopausal women and 0.57% (1 of 174) for peri/postmenopausal, and all 4 unexpected sarcomas were leiomyosarcoma. The incidence of unexpected sarcoma progressively increased with higher uterine weight with an incidence of 0.03% (1 of 2993) among women with a uterine weight <250 g vs 15.4% (2 of 13) with a uterine weight ≥2000 g. CONCLUSION: Unexpected uterine sarcoma was low in all women undergoing hysterectomy for benign indication (0.13% or 1 in 752 surgeries) while it was increased in women with uterine fibroids (0.39% or 1 in 256 surgeries). Peri/postmenopausal women, women with large uteri, and age ≥45 years were risk factors for sarcoma.

Vilaprisan for treating uterine fibroids.

INTRODUCTION: The medical strategy to antagonize myoma size and related-symptoms is to reduce estrogen and progesterone activity on myomas. This can be obtained with the GnRH agonist (GnRHa) or with compounds that antagonize progesterone stimulatory activity on myomas. Selective progesterone receptor modulators (SPRMs) bind progesterone receptor (PR), leading to both agonist and antagonist effects. The result of SPRMs's action is tissue-specific and it depends on the particular affinity and strength of each SPRM. Area covered: Ulipristal acetate (UPA) is the first SPRM registered for myoma treatment. UPA reduces heavy uterine bleeding within 7 days from the onset of treatment, whereas a longer time is required with GnRHa treatment. Vilaprisan is a novel powerful SPRM. Phase I and II studies give encouraging results on the efficacy of vilaprisan at different doses. Like other SPRMs, vilaprisan induces benign changes of endometrium (PR modulator-associated endometrial changes, PAECs). These disappear as treatment is discontinued. Unlike GnRHa treatment, neither UPA nor vilaprisan induce hypoestrogenism and associated symptoms. Phase III studies are ongoing to confirm efficacy and safety of vilaprisan in long-term treatment of symptomatic fibroids. Expert opinion: It is fundamental to underline the rapidity of action (only 3 days) in the control of myoma-related bleeding.

The stimulation of the vaginal immune system with short-term administration of a vaginal gel containing fraction of Propionibacterium acnes, hyaluronic acid and polycarbophil is efficacious in vaginal infections dependent on disorders in the vaginal ecosystem.

The vaginal immune system (VIS) is the first defense against antigens recognized as foreign. Substances capable of locally activating the VIS could be a valid strategy to treat vulvo-vaginal infections (VVI), caused by changes in the vaginal ecosystem, such as bacterial vaginosis (BV), vulvo-vaginal candidiasis (CA), and mixed vaginitis (MV). Bacterial lysates, obtained by crushing bacterial cultures, exert immuno-modulatory activities. The parietal fraction from Propionibacterium acnes is a patent of Depofarma (MoglianoVeneto, Italy). The preparation that associates such fraction to hyaluronic acid and polycarbophil is a registered trademark, commercially available in Italy as vaginal gel, Immunovag®. The study aimed to evaluate whether a 5-day-treatment with Immunovag® improves the symptoms and signs of VVI, in 60 women with Gardnerella vaginalis (GV), 154 with CA, 95 with MV, diagnosed with vulvar vaginal swab (VVS), and in 283 with BV, diagnosed with the Amsel criteria. At the end of the treatment (visit 2), the symptoms and signs of VVI disappeared in a significant number of subjects (χ2p < .02 vs pre-treatment) in all VVI groups, and their intensity was significantly (p < .0002) reduced in the subjects in which they were still present. Immunovag® represents a valid treatment of VVI induced by changes in the vaginal ecosystem.

PROM and Labour Effects on Urinary Metabolome: A Pilot Study.

Since pathologies and complications occurring during pregnancy and/or during labour may cause adverse outcomes for both newborns and mothers, there is a growing interest in metabolomic applications on pregnancy investigation. In fact, metabolomics has proved to be an efficient strategy for the description of several perinatal conditions. In particular, this study focuses on premature rupture of membranes (PROM) in pregnancy at term. For this project, urine samples were collected at three different clinical conditions: out of labour before PROM occurrence (Ph1), out of labour with PROM (Ph2), and during labour with PROM (Ph3). GC-MS analysis, followed by univariate and multivariate statistical analysis, was able to discriminate among the different classes, highlighting the metabolites most involved in the discrimination.

Long-acting reversible contraception (LARC) with the intrauterine system with levonorgestrel (6 mcg/d): observational study on the acceptability, quality of life, and sexuality in Italian women.

This observational study was conducted in healthy premenopausal women, who presented themselves for contraception with an intrauterine system (IUS) releasing LNG (6 mcg/d) (Jaydess®, Bayer, Germany) at the outpatient Family Planning Clinics of the Departments of Obstetrics and Gynaecology of the Universities of Cagliari and Sassari (CA/SS), University-Hospitals of CA/SS (Italy). After a screening visit, 31 women without contraindications to Jaydess® were included in the study. No difficulty in Jaydess® insertion (Ji) was found in 87% of subjects, with pelvic pain (PP) (visual analogic scale, VAS:5.33 ± 2.54) reported by 27/31 subjects at the Ji. Pelvic pain was reported by 17/31 subjects on the first day (VAS: 3.07 ± 3.1), 16/31 subjects on the second day (VAS:2.37 ± 2.71), and 11/31 subjects on the third day (VAS:1.18 ± 2.02) from Ji, with a significant (p < .001) decrease in the intensity. The primary purposes of the study were to evaluate whether a 12-month-treatment (12-M-T) with Jaydess® interferes on either the quality of life (QoL) or sexuality. Jaydess® did not modify either QoL or sexuality in the 25 subjects who completed the 12-M-T. Throughout the 12-M-T, PP, or pregnancies were not found; the menstrual blood loss was significantly (p < .0001) reduced, and the intensity VAS of dysmenorrhea (#14 subjects) significantly (p < .001) improved.

Very low dose of flutamide in the treatment of hyperandrogenism.

Hyperandrogenism is a condition affecting 5-10% of adolescents. The aim of this study was to evaluate the efficacy of very low dose of flutamide in the treatment of hyperandrogenism in adolescence. One hundred and fifty-eight patients, presenting severe acne and/or hirsutism, received 62.5 mg/day of flutamide + ethinylestradiol + gestodene for 18 months. The patients were subjected to assessments of hepatic enzymes levels. Thirty subjects treated with drospirenone + ethinylestradiol represented the control group. After 18 months of treatment, it was obtained a decrease of hirsutism (-39.9%), an almost recovery of acne (98% of patients) with better results of those obtained in control group. Only one case of light hypertransaminasemia was recorded, regressed spontaneously. Very low dose of flutamide was successful and safe and in the treatment of hyperandrogenism in adolescence.

Body composition and psychological improvement in healthy premenopausal women assuming the oral contraceptive containing micronized estradiol (E2) and nomegestrol acetate (NOMAC).

This observational study was conducted in healthy premenopausal women, who presented themselves for contraceptive advice at the outpatient Family Planning Clinics of the Department of Obstetrics and Gynecology of the University of Cagliari, Hospital-University of Cagliari (Italy). After a screening period of three menstrual cycles, 48 women without contraindications to estroprogestin contraceptives (OCs) were included in the study. The primary purposes of the study were to evaluate whether a 12-month-treatment with the combined OC containing micronized estradiol (1.5 mg, E2) plus nomegestrol acetate (2.5 mg, NOMAC) (E2/NOMAC) interfere on anthropometric indices (AI), body composition (BC) and psychological status (PS). In subjects with dysmenorrhea (#36), its intensity was evaluated using the visuo analogic scale (VAS), both before and during the 12-month-treatment with E2/NOMAC. E2/NOMAC did not modify neither AI nor BC in the 40 subjects who concluded the study. The PS and the VAS of dysmenorrhea were significantly (p < 0.0001) improved from the first cycle of treatment and throughout the E2/NOMAC treatment in comparison with basal values. The study suggests that E2/NOMAC is devoid of negative effects on AI and BC, with additional benefits on PS and dysmenorrhea.

Pregnancy Complications After Hysteroscopic Metroplasty: A Ten-Year Case-Control Study.

INTRODUCTION: Septate uterus is one of the most common congenital uterine anomalies and it may effect female reproductive health causing different obstetric complications, in particular miscarriages and reduction of fertility. MATERIALS AND METHODS: We conducted a retrospective case-control (1:4) comparative study (Canadian Task Force Classification II-2) with the purpose to evaluate pregnancy complications (abnormal fetal presentations, preterm deliveries, and caesarean sections) and reproductive outcome after hysteroscopic metroplasty. We studied retrospectively two groups: 62 women that delivered after metroplasty (group A); and a control group of 248 women with no history of hysteroscopic metroplasty that delivered in the same period in our hospital (group B). RESULTS: The rate of abnormal fetal presentations was significantly higher in study group A versus control group B (22.58% [14/62] vs. 4.03% [10/248], p<0.0001). Caesarean section rate was significantly higher in group A versus group B (66.12% [41/62] vs. 35.08% [87/248], p<0.0001), and preterm deliveries rate was significantly higher in group A versus group B (14.51% [9/62] vs. 6.45% [16/248], p= 0.037). Furthermore, in group A, we observed a significant reduction of the abortion rate and an increase in the total number of live births after metroplasty. CONCLUSIONS: In our series of cases, we have observed a high rate of some pregnancy complications after metroplasty compared to the general population, such as preterm deliveries and fetal malpresentations with a higher rate of caesarean sections. Hysteroscopic metroplasty has been proven to improve the overall reproductive outcome by reducing miscarriage rate and increasing live birth rate. In our opinion, benefits obtained after metroplasty must be considered greater than the adverse pregnancy outcomes observed with our series.

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

BACKGROUND: Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. METHODS/DESIGN: In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. DISCUSSION: The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan.

Review and meta-analysis of prospective randomized controlled trials (RCTs) comparing laparo-endoscopic single site and multiport laparoscopy in gynecologic operative procedures.

PURPOSE: To critically appraise published randomized controlled trials (RCTs) comparing laparo-endoscopic single site (LESS) and multi-port laparoscopic (MPL) in gynecologic operative surgery; the aim was to assess feasibility, safety, and potential benefits of LESS in comparison to MPL. METHODS: A systematic review and meta-analysis of eleven RCTs. Women undergoing operative LESS and MPL gynecologic procedure (hysterectomy, cystectomy, salpingectomy, salpingo-oophorectomy, myomectomy). Outcomes evaluated were as follows: postoperative overall morbidity, postoperative pain evaluation at 6, 12, 24 and 48 h, cosmetic patient satisfaction, conversion rate, body mass index (BMI), operative time, blood loss, hemoglobin drop, postoperative hospital stay. RESULTS: Eleven RCTs comprising 956 women with gynecologic surgical disease randomized to either LESS (477) or MPL procedures (479) were analyzed systematically. The LESS approach is a surgical procedure with longer operative and better cosmetic results time than MPL but without statistical significance. Operative outcomes, postoperative recovery, postoperative morbidity and patient satisfaction are similar in LESS and MPL. CONCLUSION: LESS may be considered an alternative to MPL with comparable feasibility and safety in gynecologic operative procedures. However, it does not offer the expected advantages in terms of postoperative pain and cosmetic satisfaction.

Overview of elagolix for the treatment of endometriosis.

INTRODUCTION: Suppression of sex-steroid secretion is required in a variety of gynecological conditions. This can be achieved using gonadotropin releasing hormone (GnRH) agonists that bind pituitary gonadotropin receptors and antagonize the link-receptor of endogenous GnRH, inhibiting the mechanism of GnRH pulsatility. On the other hand, GnRH antagonists immediately reduce gonadal steroid levels, avoiding the initial stimulatory phase of the agonists. Potential benefits of GnRH antagonists over GnRH agonists include a rapid onset and reversibility of action. Older GnRH antagonists are synthetic peptides, obtained by modifications of certain amino acids in the native GnRH sequence. They require subcutaneous injections, implantation of long-acting depots. The peptide structure is responsible for histamine-related adverse events and the tendency to elicit hypersensitivity reactions. AREAS COVERED: Research has worked towards the development of non-peptidic molecules exerting antagonist action on GnRH. They are available for oral administration and may have a more beneficial safety profile in comparison with peptide GnRH antagonists. This article focuses on the data of the literature about elagolix, a novel non-peptidic GnRHantagonist, in the treatment of endometriosis. EXPERT OPINION: Elagolix demonstrated efficacy in the management of endometriosis-associated pain and had an acceptable safety and tolerability profile. However, further studies are necessary to evaluate its non-inferiority in comparison with other endometriosis's treatments.

Effect of Estradiol valerate plus dienogest on body composition of healthy women in the menopausal transition: a prospective one-year evaluation.

In the menopausal transition (MT), combined oral contraceptive (COC) should be chosen accordingly to its neutrality on liver metabolism and to its ability to counter the increase of fat mass (FM) that occurs in this reproductive period of life. This prospective multi-centric observational study was conducted on 36 women in their MT at the Universities of Cagliari, Modena and Naples. The body weight (BW), the Body Mass Index (BMI), the waist to hip ratio (WHR), the measurement of body composition (BC) with the Multi-frequency Bioelectrical Impedance (MF-BIA) were performed before, at the 6th and at the 12th month of the study in which a group of women (control group; N.18) did not assume COC, whereas the other 18 women assumed the four-phasic COC containing estradiol valerate (EV) associated with dienogest (EV/DNG group). In comparison to controls in the EV/DNG group, a significant decrease (p < 0.05) of BW (58.8 ± 7.6 to 57.3 ± 7.0), BMI (24.1 ± 2.7 to 23.5 ± 2.8), WHR (0.82 ± 0.052 to 0.79 ± 0.048) and FM (17.7 ± 5.4 to 16.4 ± 5.6) was observed. In controls, FM significantly increased (17.0 ± 11 to 17.7 ± 2.7; p < 0.05). In conclusion, these results suggest that the anti-androgenic and progestinic activities of DNG associated with a weak estrogenic activity of EV, is a contraceptive method capable of counteracting the negative changes of BC occurring in the MT.