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Objective: To describe effects of non‐ablative erbium‐doped:yttrium‐aluminium‐garnet (Er:YAG) laser on vaginal atrophy induced by iatrogenic menopause in the ewe. Design: Animal experimental, randomised, sham and estrogen‐treatment controlled study with blinding for primary outcome. Setting: KU Leuven, Belgium. Sample: Twenty‐four ewes. Methods: Menopause was surgically induced, after which the ewes were randomised to three groups receiving vaginal Er:YAG laser application three times, with a 1‐month interval; three sham manipulations with a 1‐month interval; or estrogen replacement and sham manipulations. At given intervals, ewes were clinically examined and vaginal wall biopsies were taken. Vaginal compliance was determined by passive biomechanical testing from explants taken at autopsy. Main outcome measures: Vaginal epithelial thickness (primary), composition of the lamina propria (collagen, elastin, glycogen and vessel content), vaginal compliance, clinical signs. Results: Animals exposed to Er:YAG laser application and sham manipulation, but not to estrogens, displayed a significant and comparable increase in vaginal epithelial thickness between baseline and 7 days after the third application (69% and 67%, respectively, both P < 0.0008). In laser‐treated ewes, temporary vaginal discharge and limited thermal injury were observed. Estrogen‐substituted ewes displayed a more prominent increase in epithelial thickness (202%; P < 0.0001) and higher vaginal compliance (P < 0.05). None of the interventions induced changes in the lamina propria. Conclusions: Vaginal Er:YAG laser has comparable effect to sham manipulation in menopausal ewes. Vaginal Er:YAG laser has comparable effect to sham manipulation in menopausal ewes #LASER #GSM #RCT. Vaginal Er:YAG laser has comparable effect to sham manipulation in menopausal ewes #LASER #GSM #RCT. [ABSTRACT FROM AUTHOR]

Aims: To determine predictors of neonatal adiposity and differences in associations by fetal sex in women with gestational diabetes mellitus (GDM), normal-weight and overweight (BMI ≥ 25 kg/m 2 ) normal glucose-tolerant women (NGT)., Methods: Skinfold thickness was measured in 576 newborns, and cord blood leptin, c-peptide and lipids in 327 newborns in a multi-centric prospective cohort study., Results: Compared to neonates of normal-weight NGT women (327), neonates of women with GDM (97) were more often large-for-gestational age (LGA) (16.5% vs 8.6%, p = 0.024) ,but the macrosomia rate (8.2% vs 5.8%, p = 0.388), sum of skinfolds (13.9 mm ± 2.9 vs 13.3 mm ± 2.6, p = 0.067), neonatal fat mass (1333.0 g ± 166.8 vs 1307.3 g ± 160.9, p = 0.356), and cord blood biomarkers were not significantly different. Compared to neonates of normal-weight NGT women, neonates of overweight NGT women (152) had higher rates of macrosomia (12.5% vs 5.8%, p = 0.012), LGA (17.1% vs 8.6%, p = 0.006), higher sum of skinfolds (14.3 mm ± 2.6 vs 13.2 mm ± 2.6, p < 0.001), neonatal fat mass (1386.0 g ± 168.6 vs 1307.3 g ± 160.9, p < 0.001), % neonatal fat mass > 90th percentile (15.2% vs 7.1%, p < 0.001), without significant differences in cord blood biomarkers. Maternal BMI, fasting glycemia, triglycerides, gestational weight gain, cord blood leptin ,and cord blood triglycerides were independent predictors for neonatal adiposity. Gestational weight gain was positively associated with adiposity in boys only., Conclusion: Compared to neonates of normal-weight NGT women, neonates of GDM women have higher LGA rates but similar adiposity, while neonates of overweight NGT women have increased adiposity. Limiting gestational weight gain might be especially important in the male fetus to reduce neonatal adiposity.

Screening for gestational diabetes mellitus (GDM) is important to improve pregnancy outcomes and to prevent type 2 diabetes after pregnancy. The 'International Association of Diabetes and Pregnancy Study Groups' (IADPSG) recommends a universal one-step approach with the 75 g oral glucose tolerance test (OGTT) for screening of GDM. The IADPSG recommendation remains controversial due to the important increase in GDM prevalence and increased workload. After review of the latest evidence and based on data from the 'Belgian Diabetes in Pregnancy' study, members of the Diabetes Liga, the Flemish associations of general physicians (Domus Medica), obstetricians (VVOG), midwives (VVOB), diabetes nurse educators (BVVDV) and clinical chemists (RBSLM) have reached a new consensus on screening for GDM in Flanders. This new consensus recommends universal screening for overt diabetes when planning pregnancy or at the latest at first prenatal contact, preferably by measuring the fasting plasma glucose by using the same diagnostic criteria as in the non-pregnant state. In women with impaired fasting glycaemia, but also in normoglycemic obese women and women with a previous history of GDM, lifestyle counselling is advised with screening for GDM with a 75 g OGTT at 24 weeks. In all other women, we recommend a two-step screening strategy with a 50 g glucose challenge test (GCT) at 24 weeks followed by a 75 g OGTT when the glucose level 1 hour after the GCT ≥130 mg/dl. Diagnosis of GDM is made using the IADPSG criteria for GDM. Postpartum screening for subsequent glucose abnormalities should be advocated and organized for every woman with GDM.

Aims: We aimed to develop a prediction model based on clinical and biochemical variables for gestational diabetes mellitus (GDM) based on the 2013 World Health Organization (WHO) criteria., Methods: A total of 1843 women from a Belgian multi-centric prospective cohort study underwent universal screening for GDM. Using multivariable logistic regression analysis, a model to predict GDM was developed based on variables from early pregnancy. The performance of the model was assessed by receiver-operating characteristic (AUC) analysis. To account for over-optimism, an eightfold cross-validation was performed. The accuracy was compared with two validated models (van Leeuwen and Teede)., Results: A history with a first degree relative with diabetes, a history of smoking before pregnancy, a history of GDM, Asian origin, age, height and BMI were independent predictors for GDM with an AUC of 0.72 [95% confidence interval (CI) 0.69-0.76)]; after cross-validation, the AUC was 0.68 (95% CI 0.64-0.72). Adding biochemical variables, a history of a first degree relative with diabetes, a history of GDM, non-Caucasian origin, age, height, weight, fasting plasma glucose, triglycerides and HbA 1c were independent predictors for GDM, with an AUC of the model of 0.76 (95% CI 0.72-0.79); after cross-validation, the AUC was 0.72 (95% CI 0.66-0.78), compared to an AUC of 0.67 (95% CI 0.63-0.71) using the van Leeuwen model and an AUC of 0.66 (95% CI 0.62-0.70) using the Teede model., Conclusions: A model based on easy to use variables in early pregnancy has a moderate accuracy to predict GDM based on the 2013 WHO criteria.

Aims/hypothesis: This study aimed to determine the characteristics and pregnancy outcomes across different subtypes of gestational diabetes mellitus (GDM) based on insulin resistance., Methods: GDM subtypes were defined in 1813 pregnant women from a multicentre prospective cohort study, stratified according to insulin resistance, based on Matsuda index below the 50th percentile of women with normal glucose tolerance (NGT), during a 75 g OGTT at 24-28 weeks' gestation. GDM was diagnosed in 12.4% (n = 228) of all participants based on the 2013 WHO criteria., Results: Compared with women with NGT (1113 [61.4%] of the total cohort) and insulin-sensitive women with GDM (39 [17.1%] women with GDM), women with GDM and high insulin resistance (189 [82.9%] women with GDM) had a significantly higher BMI, systolic BP, fasting plasma glucose (FPG), fasting total cholesterol, LDL-cholesterol and triacylglycerol levels in early pregnancy. Compared with women with NGT, insulin-sensitive women with GDM had a significantly lower BMI but similar BP, FPG and fasting lipid levels in early pregnancy. Compared with women with NGT, women with GDM and high insulin resistance had higher rates of preterm delivery (8.5% vs 4.7%, p = 0.030), labour induction (42.7% vs 28.1%, p < 0.001), Caesarean section (total Caesarean sections: 28.7% vs 19.4%, p = 0.004; emergency Caesarean sections: 16.0% vs 9.7%, p = 0.010), neonatal hypoglycaemia (15.4% vs 3.5%, p < 0.001) and neonatal intensive care unit admissions (16.0% vs 8.9%, p = 0.003). In multivariable logistic regression analyses using different models to adjust for demographics, BMI, FPG, HbA 1c , lipid levels and gestational weight gain in early pregnancy, preterm delivery (OR 2.41 [95% CI 1.08, 5.38]) and neonatal hypoglycaemia (OR 4.86 [95% CI 2.04, 11.53]) remained significantly higher in women with GDM and high insulin resistance compared with women with NGT. Insulin-sensitive women with GDM had similar pregnancy outcomes as women with NGT. The need for insulin treatment during pregnancy and the rate of glucose intolerance in the early postpartum period were not significantly different among the GDM subtypes., Conclusions/interpretation: GDM with high insulin resistance represents a more adverse metabolic profile with a greater risk of adverse pregnancy outcomes.

Background For several decades, transient hypothyroxinemia of prematurity (THOP) has been a topic of debate. The pathophysiology is incompletely understood and consensus on the therapeutic approach is lacking. This study aimed at gaining a better insight into the pathogenesis by studying the trends in thyroid hormone (TH) levels during the first week of life. Methods This single-center prospective observational study analyzed the plasma levels of total thyroxine (T4) and free thyroxine (fT4), total triiodothyronine (T3), thyroid-stimulating hormone (TSH) and T4-binding globulin (TBG) in cord blood and at the end of the first week of life in 120 preterm infants (gestational age [GA] <37 weeks). The change over time was calculated (delta, ∆). The impact of perinatal and subsequently postnatal variables on ∆ was studied by hierarchical multiple regression. The impact of ∆ on the neurodevelopmental outcome at the corrected ages of 9 and 24 months, measured by the Bayley Scales of Infant Development (BSID)-II, was assessed by logistic regression. Results ∆fT4 levels were negatively affected by GA and use of dopamine, whereas only GA was associated with low ∆T3 levels. Negative ∆fT4 levels were present in 75% of the extremely low-for-gestational-age infants, whereas 23.5% had a negative ∆T3 level. There was an increased risk for an abnormal mental developmental score (<85) with decreasing ∆T3 at 9 months, corrected age, but not at 24 months. Conclusions A negative evolution in circulating TH levels is principally an immaturity phenomenon, whereas dopamine can further suppress the hypothalamic-pituitary-thyroid axis. There is at least a temporary negative effect of this evolution on the infants' neurodevelopment.

Background: The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recommends universal screening with a 75 g oral glucose tolerance test (OGTT) using stricter criteria for gestational diabetes (GDM). This may lead to important increases in the prevalence of GDM and associated costs, whereas the gain in health is unclear. The goal of 'The Belgian Diabetes in Pregnancy Study' (BEDIP-N) is to evaluate the best screening strategy for pregestational diabetes in early pregnancy and GDM in an ethnically diverse western European population. The IADPSG screening strategy will be followed, but in addition risk questionnaires and a 50 g glucose challenge test (GCT) will be performed, in order to define the most practical and most cost effective screening strategy in this population., Methods: BEDIP-N is a prospective observational cohort study in 6 centers in Belgium. The aim is to enroll 2563 pregnant women in the first trimester with a singleton pregnancy, aged 18-45 years, without known diabetes and without history of bariatric surgery. Women are universally screened for overt diabetes and GDM in the first trimester with a fasting plasma glucose and for GDM between 24-28 weeks using the 50 g GCT and independently of the result of the GCT, all women will receive a 75 g OGTT using the IADPSG criteria. Diabetes and GDM will be treated according to a standardized routine care protocol. Women with GDM, will be reevaluated three months postpartum with a 75 g OGTT. At each visit blood samples are collected, anthropometric measurements are obtained and self-administered questionnaires are completed. Recruitment began in April 2014., Discussion: This is the first large, prospective cohort study rigorously assessing the prevalence of diabetes in early pregnancy and comparing the impact of different screening strategies with the IADPSG criteria on the detection of GDM later in pregnancy., Trial Registration: ClinicalTrials.gov: NCT02036619. Registered 14-1-2014.

Objective: Vulvectomy for vulvar malignancy can affect sexual functioning based on anatomic, physiologic, psychologic, and relational mechanisms. The aims of this study were to prospectively investigate sexual adjustment of women with vulvar malignancy during a follow-up period of 1 year after vulvectomy and to compare the results with healthy control women., Methods: In this prospective controlled study, participants completed the Beck Depression Inventory scale, World Health Organization-5 Well-being scale, Dyadic Adjustment Scale, Short Sexual Functioning Scale, and Specific Sexual Problems Questionnaire to assess various aspects of psychosocial and sexual functioning just before surgery, 6 months, and 1 year after treatment., Results: Twenty-nine women with vulvar malignancy and 29 healthy controls completed the survey. Compared with the presurgery status, no significant differences were found in psychologic, relational, and sexual functioning in women after surgery for vulvar malignancy. Compared with healthy control women, women with vulvar malignancy reported significantly lower psychologic well-being and quality of partner relationship, both before and after treatment. Moreover, significantly more patients with vulvar malignancy reported preoperative and postoperatively sexual dysfunctions than healthy controls, including entry and deep dyspareunia, abdominal pain during intercourse, reduced ability to achieve orgasm, and reduced intensity of orgasm., Conclusions: This prospective study yielded no differences in psychosocial and sexual functioning for women with vulvar malignancy before and after vulvectomy. However, when compared with healthy controls, patients with vulvar malignancy are at high risk for sexual dysfunctions, both before and after surgical treatment.

Pelvic surgery for gynecological cancer can affect sexuality through a number of anatomical, physiological and psychological mechanisms. We aimed to examine the prevalence of sexual dysfunction and psychological functioning in women who underwent pelvic surgery for gynecological cancer. Fifty women who underwent pelvic surgery for vulvar, cervical or endometrial cancer in a gynecological oncology unit completed questionnaires evaluating marital satisfaction (DAS), depression (BDI-II) and sexual functioning (SSFS and an in-house Specific Sexual Problems Questionnaire). Medical records were used to obtain disease-specific data. The control group consisted of 39 healthy age-matched control women attending an outpatient screening clinic. Significantly more women with gynaecological cancer than controls reported sexual problems (83 vs 20%), including decreased desire (76 vs 14%) and impaired vaginal lubrication (42 vs 9%). Pelvic surgery was specifically related to changed intensity of orgasm (43%), reduced vaginal sensitivity (38%), vaginal elasticity (30%), superficial dyspareunia (27%), vaginal narrowing (26%) and shortening (22%). Although no significant differences were found between either group for depression (17% vs 13%) or total quality of the partner relationship, women with a history of gynecological cancer reported significant lower marital cohesion. These results indicate that although the psychological adjustment of women who underwent pelvic surgery seems to be satisfactory, they seem to be at risk for sexual dysfunctions.

This paper identifies the symptom profile associated with the four main diagnoses of functional digestive disorders (dyspepsia, gastro-oesophageal reflux disease (GORD), gastritis, and constipation) made by general practitioners in Belgium. Results are also presented from a multicentre study in which the effects of cisapride, administered as an oral tablet or suspension, were evaluated in patients with these functional digestive disorders. Analysis of symptom patterns revealed that early satiety and postprandial abdominal bloating were the most prominent symptoms, followed by eructation (belching), heartburn, regurgitation, postprandial epigastric burning or discomfort, and nausea. These symptoms occurred in all diagnostic groups. However, different symptom patterns were associated with each of the disorders; for example, heartburn and regurgitation were the core symptoms in patients diagnosed as having GORD, early satiety and abdominal bloating were characteristic of patients diagnosed with dyspepsia, and fasting or postprandial pain were characteristic of patients given the diagnosis of gastritis. Therefore, it appears that these diagnoses used by general practitioners in Belgium closely correspond to reflux-like, dysmotility-like and ulcer-like dyspepsia, as defined by an international working party. Cisapride improved the core symptoms in about 80% of patients with GORD or dyspepsia, relieved all epigastric symptoms in about 80% of patients with gastritis, and significantly decreased the use of laxatives and increased stool frequency in constipated patients. Cisapride was well tolerated and thus appears to be a useful option in the treatment of functional digestive disorders in a general practice setting.