Prediction of spontaneous preterm birth using CCL2 and CXCL10 in maternal serum of symptomatic high-risk pregnant women: a prospective cohort study.

INTRODUCTION: CCL2 and CXCL10 are putative biomarkers for the prediction of spontaneous preterm birth. This study evaluates these markers in a cohort of pregnant high-risk women. MATERIAL AND METHODS: In our prospective study, we included 109 women with signs of preterm labor between 20 + 0 and 31 + 6 weeks of gestation. Inclusion criteria were regular (< 3/30 min) or painful contractions, cervical length < 25 mm or a history of previous preterm birth (PTB). Blood samples were obtained upon first admission to our clinic. Biomarker concentrations were measured using pre-coated sandwich immunoassays (ELISA). Primary study outcome was spontaneous preterm birth < 34 weeks, secondary outcome was delivery < 37 weeks or within seven days after study inclusion. RESULTS: Sixteen women (14.7%) delivered < 34 weeks and twenty women between 34 + 0 and 36 + 6 weeks (18.4%). Six patients (5.5%) gave birth within seven days after study admission. CXCL10 showed higher medium serum levels in women with PTB < 34 weeks (115 pg/ml compared to 61 pg/ml ≥ 34 weeks; p < 0.001) and < 37 weeks (103 pg/ml vs. 53 pg/ml; p < 0.001). In contrary, lower CCL2 serum levels were associated with PTB < 34 weeks (46 pg/ml vs. 73 pg/ml; p = 0.032) and birth within 7 days (25 pg/ml vs. 73 pg/ml; p = 0.008). The CXCL10/CCL2-ratio further improved the predictive model with a ROC-AUC of 0.83 (95% CI 0.73-0.93, p < 0.001) for delivery < 34 weeks. These corresponds to a sensitivity, specificity and positive predictive value of 0.67, 0.86 and 0.43 at a cut-off of 2.2. CONCLUSION: Low maternal serum CCL2 levels are associated with a higher risk of preterm delivery within seven days. High CXCL10 serum levels are more associated with a high risk for preterm birth < 34 weeks. Elevated CXCL10/CCL2-ratio is showing the best predictive performance. TRIAL REGISTRATION NUMBER (DRKS-ID): DRKS00010763, Registration date: September 02, 2016.

Prediction of recurrent gestational diabetes mellitus: a retrospective cohort study.

BACKGROUND: Women after gestational diabetes mellitus (GDM) are at increased risk for development of GDM recurrence. It was the aim of our study to evaluate factors for prediction of risk of recurrence. METHODS: In this retrospective cohort study we included 159 women with GDM and a subsequent pregnancy. Putative risk factors for GDM recurrence were analyzed by logistic regression models. Results were compared to a cohort of age-matched women without GDM as controls (n = 318). RESULTS: The overall risk of GDM recurrence was 72.3% (115/159). Risk factors of recurrence were a body mass index (BMI) ≥ 30 kg/m2 before the index pregnancy (odds ratio (OR) 2.8 [95% CI 1.3-6.2], p = 0,008), a BMI ≥ 25 kg/m2 before the subsequent pregnancy (OR 2.7 [95% CI 1.3-5.8]. p = 0.008), a positive family history (OR 4.3 [95% CI 1.2-15.4], p = 0.016) and insulin treatment during the index pregnancy (OR 2.3 [95% CI 1.1-4.6], p = 0.023). Delivery by caesarean section (index pregnancy) was of borderline significance (OR 2.2 [95% CI 0.9-5.2], p = 0.069). Interpregnancy weight gain, excessive weight gain during the index pregnancy and fetal outcome where not predictive for GDM recurrence. Neonates after GDM revealed a higher frequency of transfer to intensive care unit compared to healthy controls (OR 2.3 [95% CI 1.1-4.6], p = 0.0225). The best combined risk model for prediction of GDM recurrence including positive family history and a BMI ≥ 25 kg/m2 before the subsequent pregnancy revealed moderate test characteristics (positive likelihood ratio 7.8 [95% CI 1.1-54.7] and negative likelihood ratio 0.7 [95% CI 0.6-0.9]) with a positive predictive value of 96.6% in our cohort. CONCLUSIONS: A positive family history of diabetes mellitus in combination with overweight or obesity were strongly associated with recurrence of a GDM in the subsequent pregnancy. Normalization of the pregravid BMI should be an effective approach for reducing the risk of GDM recurrence.

Gestational diabetes mellitus and COVID-19: results from the COVID-19-Related Obstetric and Neonatal Outcome Study (CRONOS).

BACKGROUND: Gestational diabetes mellitus is one of the most frequent pregnancy complications with a global prevalence of 13.4% in 2021. Pregnant women with COVID-19 and gestational diabetes mellitus are 3.3 times more likely to be admitted to an intensive care unit than women without gestational diabetes mellitus. Data on the association of gestational diabetes mellitus with maternal and neonatal pregnancy outcomes in pregnant women with SARS-CoV-2 infection are lacking. OBJECTIVE: This study aimed to investigate whether gestational diabetes mellitus is an independent risk factor for adverse maternal and fetal and neonatal outcomes in pregnant women with COVID-19. STUDY DESIGN: The COVID-19-Related Obstetric and Neonatal Outcome Study is a registry-based multicentric prospective observational study from Germany and Linz, Austria. Pregnant women with clinically confirmed COVID-19 were enrolled between April 3, 2020, and August 24, 2021, at any stage of pregnancy. Obstetricians and neonatologists of 115 hospitals actively provided data to the COVID-19-Related Obstetric and Neonatal Outcome Study. For collecting data, a cloud-based electronic data platform was developed. Women and neonates were observed until hospital discharge. Information on demographic characteristics, comorbidities, medical history, COVID-19-associated symptoms and treatments, pregnancy, and birth outcomes were entered by the local sites. Information on the periconceptional body mass index was collected. A primary combined maternal endpoint was defined as (1) admission to an intensive care unit (including maternal mortality), (2) viral pneumonia, and/or (3) oxygen supplementation. A primary combined fetal and neonatal endpoint was defined as (1) stillbirth at ≥24 0/7 weeks of gestation, (2) neonatal death ≤7 days after delivery, and/or (3) transfer to a neonatal intensive care unit. Multivariable logistic regression analysis was performed to evaluate the modulating effect of gestational diabetes mellitus on the defined endpoints. RESULTS: Of the 1490 women with COVID-19 (mean age, 31.0±5.2 years; 40.7% nulliparous), 140 (9.4%) were diagnosed with gestational diabetes mellitus; of these, 42.9% were treated with insulin. Overall, gestational diabetes mellitus was not associated with an adverse maternal outcome (odds ratio, 1.50; 95% confidence interval, 0.88-2.57). However, in women who were overweight or obese, gestational diabetes mellitus was independently associated with the primary maternal outcome (adjusted odds ratio, 2.69; 95% confidence interval, 1.43-5.07). Women who were overweight or obese with gestational diabetes mellitus requiring insulin treatment were found to have an increased risk of a severe course of COVID-19 (adjusted odds ratio, 3.05; 95% confidence interval, 1.38-6.73). Adverse maternal outcomes were more common when COVID-19 was diagnosed with or shortly after gestational diabetes mellitus diagnosis than COVID-19 diagnosis before gestational diabetes mellitus diagnosis (19.6% vs 5.6%; P<.05). Maternal gestational diabetes mellitus and maternal preconception body mass index of ≥25 kg/m2 increased the risk of adverse fetal and neonatal outcomes (adjusted odds ratio, 1.83; 95% confidence interval, 1.05-3.18). Furthermore, overweight and obesity (irrespective of gestational diabetes mellitus status) were influential factors for the maternal (adjusted odds ratio, 1.87; 95% confidence interval, 1.26-2.75) and neonatal (adjusted odds ratio, 1.81; 95% confidence interval, 1.32-2.48) primary endpoints compared with underweight or normal weight. CONCLUSION: Gestational diabetes mellitus, combined with periconceptional overweight or obesity, was independently associated with a severe maternal course of COVID-19, especially when the mother required insulin and COVID-19 was diagnosed with or after gestational diabetes mellitus diagnosis. These combined factors exhibited a moderate effect on neonatal outcomes. Women with gestational diabetes mellitus and a body mass index of ≥25 kg/m2 were a particularly vulnerable group in the case of COVID-19.

[Management of Infection in Threatened Preterm Birth - A Survey of German Perinatal Centers]. / Infektionsmanagement bei drohender Frühgeburt ­ eine Umfrage an deutschen Perinatalzentren.

INTRODUCTION: In spite of insufficient evidence, we assume a high willingness to diagnose and treat vaginal infections in threatened preterm births in Germany. METHODS: Online survey on the management of infection in threatened preterm birth in all 212 German perinatal centers. RESULTS: The response rate was 31.6% (n=67). 78.8% disclaim an empirical antibiotic treatment in threatened preterm birth below 34 weeks of gestation. Half of the remaining 14 centers always start an antibiotic treatment in cases with signs or symptoms of threatened preterm birth. 94% perform vaginal swabs for culture. 37.3% use a microscopic assessment by vaginal Nugent score or Amsel score. An abnormal vaginal microbiota is mostly treated (bacterial vaginosis 79.1%, n=53, Candida spp. 77.6%, n=52, Ureaplasma spp. 49.3%, n=33). After treatment, 70.1% agree with repeating the culture diagnosis. There is common consensus for antibiotic treatment in cases with preterm premature rupture of membranes. 72.6% favor a monotherapy with a ß-lactam antibiotic. Statements on duration of therapy were inconsistent, whereby 58% of centers treat for more than 7 days. CONCLUSION: In German perinatal centers, we observed a great willingness to diagnose and treat infections in threatened preterm birth. However, the management of infection is heterogeneous and partly contradicts the present guidelines.

Uterocervical angle as a predictor of preterm birth on a high-risk collective between 20 and 31 weeks of gestation: A cohort analysis.

INTRODUCTION: The cervical length (CL) measurement is a widely used method to estimate the risk of preterm birth. Due in particular to the high false-positive rate, the establishment of markers with improved test characteristics is a great challenge. A potential predictor of preterm birth is the uterocervical angle (UCA) and this additional measurement may improve the risk assessment. It was the aim of this study to compare the test properties of CL and UCA on patients at risk for preterm birth. MATERIAL AND METHODS: 109 patients with at least one of the following signs of threatening preterm birth between 20+0/7 and 31+6/7 weeks were included in a prospective cohort analysis: regular (>3/30 min) or painful uterine contractions, CL below 25 mm or a history of preterm birth. Exclusion criteria were premature rupture of membranes, hypertensive disorders, vaginal bleeding, surgical cerclage, Arabin pessary or cervical dilation of more than 30 mm. The determination of the UCA was carried out in a standardized manner using the image documents captured by vaginal sonographic CL measurement. The primary endpoint was preterm birth <34 weeks, secondary endpoints were delivery <37 weeks and within 7 days. RESULTS: The UCA was on average 103° and the mean UCA in preterm and term groups did not differ significantly (P = .924). The UCA was not predictive for threatened preterm birth, even if only singletons were considered. For CL the best predictive accuracy for preterm birth <34 weeks was observed at a cut-off value of 14 mm with sensitivity 0.50, specificity 0.80, positive predictive value 0.30, negative predictive value 0.90, positive likelihood ratio 2.4, negative likelihood ratio 0.6 and an odds ratio of 3.9 (95% confidence interval 1.3-11.7, P = .016). CONCLUSIONS: The assessment of UCA in patients at risk for preterm birth was not suitable to predict the probability of a threatened preterm birth. Measurement of UCA cannot be recommended in this situation.

Accuracy of immediate antepartum ultrasound estimated fetal weight and its impact on mode of delivery and outcome - a cohort analysis.

BACKGROUND: The aim of the study was to investigate the accuracy of ultrasound-derived estimated fetal weight (EFW) and to determine its impact on management and outcome of delivery. METHODS: In this single-center cohort analysis, women with a singleton term pregnancy in the beginning stages of labor were included. Women with immediately antepartum EFW (N = 492) were compared to women without ultrasound (N = 515). RESULTS: EFW was correct (deviation from birth weight ≤ 10%) in 72.2% (355/492) of patients with fetal biometry; 19.7% (97/492) were underestimated, and 8.1% (40/492) were overestimated. Newborns with a lower birth weight were more frequently overestimated, and newborns with higher birth weight were more frequently underestimated. The mean difference between EFW and real birth weight was - 114.5 g (standard deviation ±313 g, 95% confidence interval 87.1-142.0). The rate of non-reassuring fetal heart tracing (9.8% vs. 1.9%, P < 0.001) and of caesarean delivery (9.1% vs. 5.0%, P = 0.013) was higher in women with EFW. Overestimation was associated with an increased risk for delivery by caesarean section (odds ratio 2.80; 95% confidence interval 1.2-6.5, P = 0.017). After adjustment, EFW remained associated with increased non-reassuring fetal heart tracing (odds ratio 4.73; 95% confidence interval 2.3-9.6) and caesarean delivery (odds ratio 1.86; 95% confidence interval 1.1-3.1). The incidence of perineal tears of grade 3/4, shoulder dystocia, postnatal depression and neonatal acidosis did not differ between groups. CONCLUSIONS: Antepartum ultrasound-derived EFW does not improve maternal and fetal outcome and is therefore not recommended.

Acute-phase proteins in prediction of preeclampsia in patients with abnormal midtrimester uterine Doppler velocimetry.

AIMS: Manifestation of preeclampsia is characterized by an inflammatory response and altered expression of acute-phase proteins. In this study, we examined the predictive value of serum amyloid A, progranulin, transthyretin, C-reactive protein and interleukin-6. Soluble endoglin was used as control. METHODS: Maternal serum levels of the putative biomarkers were measured in 49 women with a midtrimester bilateral abnormal uterine artery Doppler velocimetry. RESULTS: Preeclampsia developed in 26.5 %. 75.0 % had an early-onset disease (<34 + 0 weeks). Delivery <34 + 0 weeks was indicated in 16.3 %. 12.2 % of patients developed a normotensive intrauterine growth restriction. All of the putative biomarkers were not predictive for preeclampsia. But serum levels of progranulin and also of soluble endoglin were increased in cases with development of a severe normotensive intrauterine growth restriction. Only soluble endoglin was predictive for the development of preeclampsia with an area under curve in the receiver operating curve analysis of 0.761 (P = 0.006). Using a cut-off level of ≥9.14 ng/mL, sensitivity, specificity, positive predictive value and negative predictive value were 53.9, 88.9, 63.6 and 84.2 %, respectively. CONCLUSIONS: Inflammation is a late event during development of preeclampsia, and acute-phase proteins are not predictive for the disease in a high-risk population without clinical symptoms during the second trimester. Progranulin is a putative new biomarker for an early detection of intrauterine growth restriction in women without concomitant hypertensive disorders. Soluble endoglin improved predictive values for preeclampsia in patients with abnormal uterine Doppler.

Biocompatibility, cell growth and clinical relevance of synthetic meshes and biological matrixes for internal support in implant-based breast reconstruction.

PURPOSE: Biological matrixes and synthetic meshes are increasingly used in implant-based breast reconstruction (IBBR). The objective was to test different materials used for internal support in IBBR in regards to biocompatibility and discuss possible limitations in a clinical context. MATERIALS AND METHODS: In vitro investigations were performed on four relevant cell lines: Normal Human Dermal Fibroblasts (NHDF), Human White Preadipocytes (HWP), Endothelial cells (HDMEC) and Skeletal muscle cells (SkMC). A titanium-coated polypropylene mesh (TiLOOP Bra), a partially resorbable mesh (SERAGYN BR) and a porcine derived biologic matrix (Strattice) were investigated. Test of cytotoxicity, cell proliferation and oxidative stress was performed. Real-time cell analysis was used to determine adhesion rate. Light- and scanning electron microscopy investigated cell migration. RESULTS: No relevant cytotoxicity was detected for any mesh or matrix. Good cell proliferation was observed in all materials with best results for NHDF and SkMC. For HWP and HDMEC decreased proliferation and adherence to the synthetic meshes and biologic matrix were observed. Real-time cell analysis of fibroblasts incubated with the corresponding material, showed increased impedance for the synthetic meshes. A morphologic cell change was observed within all materials. Scanning electron microscopy showed good cell penetration into the meshes and matrix. The material compositions did not seem to influence the clinical outcome, although the biological matrix was much thicker compared to the synthetic meshes. CONCLUSION: Biochemical examination showed good biocompatibility for the investigated meshes and matrix. All products seem to have their value in IBBR and can be recommended for IBBR.

Diagnosis of ruptured breast implants through high-resolution ultrasound combined with real-time elastography.

BACKGROUND: Implant rupture as a late complication of breast implant surgery is often a silent phenomenon that is difficult to diagnose. Sonoelastography is a new ultrasound-based technique that allows assessment of tissue elasticity. OBJECTIVES: This study was undertaken to evaluate elastographic findings in normal and ruptured breast implants. METHODS: This prospective study included 28 implants in 16 patients, all of whom underwent high-resolution ultrasound and real-time elastography. The diagnosis of implant rupture was confirmed by surgery. RESULTS: Implant rupture was diagnosed in 5 out of 28 implants (17.9%). In those patients with ruptured implants, 3 had no symptoms, 1 presented with pain, and 1 complained of ipsilateral axillary lymph node swelling. Implants with a homogenous anechoic interior were considered to be intact. Ultrasound findings indicating implant rupture included multiple parallel echogenic lines in the implant interior in 2 cases and a mix of hyperechoic and hypoechoic masses in 3 cases. The feasibility of real-time elastography of implants was demonstrated in all cases. Elastograms of intact implants revealed a typical blue-green-red pattern familiar from cystic lesions. In all 5 ruptured implants, elastography revealed yellow-green figures without typical layering. CONCLUSIONS: To the authors' knowledge this is the first series to combine high-resolution ultrasound with real-time elastography for the diagnosis of implant rupture. Since there are distinct differences between elastograms of intact and ruptured implants, addition of real-time elastography to conventional ultrasound may improve implant surveillance and obviate the need for magnetic resonance imaging.

Prediction of preeclampsia and induced delivery at <34 weeks gestation by sFLT-1 and PlGF in patients with abnormal midtrimester uterine Doppler velocimetry: a prospective cohort analysis.

BACKGROUND: Women with bilateral abnormal uterine artery Doppler velocimetry (UtADV) are at increased risk for an adverse pregnancy outcome. This study aimed to determine if additional assessment of midtrimester angiogenic factors improves the predictive accuracy of Doppler results for various outcome parameters. METHODS: Women with a bilateral abnormal UtADV, which was defined as a postsystolic incision and/or an increased pulsatility index greater than the 95th centile, and a singleton pregnancy were prospectively recruited between 19 + 0 and 26 + 6 weeks of gestation. Maternal serum levels of placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFLT-1) were measured with a fully automated immunoassay and their ratio was calculated. RESULTS: Angiogenic factors could predict the development of preeclampsia (PE), as well as induced delivery at <34 weeks of gestation, but failed to predict the development of normotensive intrauterine growth restriction. Twelve (24.0%) of the 50 recruited women developed PE. Nine of these patients had early-onset disease (<34 + 0 weeks). Six (12.0%) patients were delivered at <34 + 0 weeks. The most useful test results in the prediction of PE and induced delivery at <34 + 0 weeks were observed using the sFLT-1/PlGF >95th centile ratio with a sensitivity, specificity, positive predictive value, and negative predictive value (NPV) of 66.7%, 89.5%, 66.7%, and 89.5% for PE, and 85.7%, 86.1%, 50.1%, and 97.4% for induced delivery, respectively. Positive and negative likelihood ratios were 6.33 (95% CI 2.31-17.38) and 0.37 (95% CI 0.17-0.84) for PE, and 6.14 (95% CI 2.76-13.69) and 0.17 (0.03-1.02) for induced delivery, respectively. Corresponding odds ratios were 17.0 (95% CI 3.5-83.0) and 37.0 (95% CI 3.8-363.9), respectively. CONCLUSIONS: Measurement of angiogenic factors improves the specificity of an abnormal UtADV for prediction of PE. Compared with prediction of PE an abnormal sFLT-1/PlGF ratio revealed higher sensitivity for prediction of induced delivery at <34 + 0 weeks. The NPV of 97% will help to reassure most patients with an abnormal UtADV and a normal sFLT-1/PlGF ratio.

Clinical differences between early- and late-onset severe preeclampsia and analysis of predictors for perinatal outcome.

AIMS: To analyze the clinical differences between early- and late-onset cases of severe preeclampsia and to evaluate parameters that could help to predict perinatal outcome. METHODS: Over a period of 6 years, all cases of severe preeclampsia (n=68) at our institution were included in a retrospective cohort analysis. Differences between early (<34 weeks, n=44) and late (≥34 weeks, n=24) onset of the disease were evaluated. Risk factors for low 5-min Apgar score (≤7), small-for-gestational-age (SGA) infants and neonatal acidosis (umbilical arterial pH <7.20) were identified and considered in a multiple logistic regression model. RESULTS: Early- and late-onset severe preeclampsia differed from each other remarkably. Perinatal outcome was unfavorable in early-onset disease and seemed to be mainly a result of premature delivery and development of fetal growth restriction. Abnormal uterine Doppler velocimetry increased the risk of low 5-min Apgar values [odds ratio (OR) 8.0, P=0.012] and preterm birth <34+0 weeks (OR 17.9, P<0.001). An increased resistance of the umbilical artery was associated with a higher risk for SGA birth weight (OR 4.9, P=0.010). CONCLUSION: Preeclampsia is a heterogeneous syndrome even if only severe cases were analyzed. Abnormal Doppler flow characteristics facilitated the identification of patients who were at increased risk for worse perinatal outcome.

Progranulin shows cytoprotective effects on trophoblast cells in vitro but does not antagonize TNF-α-induced apoptosis.

AIMS: The glycoprotein progranulin directly binds to TNF-receptors and thereby can antagonize the inflammatory effects of TNF-α. Here we analyzed the impact of both cytokines on cytotoxicity and viability of trophoblast cells. METHODS: Isolated villous first trimester human trophoblast cells and the human choriocarcinoma cell line BeWo were treated with recombinant human progranulin and TNF-α. Analyses were performed by LDH- and MTT-assay and measurement of caspase-8-activity. RESULTS: Progranulin treatment showed some cytoprotective effects on isolated trophoblast cells. However, TNF-α-induced apoptosis was not antagonized by addition of progranulin. Effects were similar, but more pronounced in BeWo cells. CONCLUSION: The cytoprotective activity of progranulin on trophoblast cells in vitro was only weak and of doubtful biologic relevance. It was not able to antagonize TNF-α. Future studies should focus on possible paracrine activities of progranulin.

A systematic review of progranulin concentrations in biofluids in over 7,000 people-assessing the pathogenicity of GRN mutations and other influencing factors.

BACKGROUND: Pathogenic heterozygous mutations in the progranulin gene (GRN) are a key cause of frontotemporal dementia (FTD), leading to significantly reduced biofluid concentrations of the progranulin protein (PGRN). This has led to a number of ongoing therapeutic trials aiming to treat this form of FTD by increasing PGRN levels in mutation carriers. However, we currently lack a complete understanding of factors that affect PGRN levels and potential variation in measurement methods. Here, we aimed to address this gap in knowledge by systematically reviewing published literature on biofluid PGRN concentrations. METHODS: Published data including biofluid PGRN concentration, age, sex, diagnosis and GRN mutation were collected for 7071 individuals from 75 publications. The majority of analyses (72%) had focused on plasma PGRN concentrations, with many of these (56%) measured with a single assay type (Adipogen) and so the influence of mutation type, age at onset, sex, and diagnosis were investigated in this subset of the data. RESULTS: We established a plasma PGRN concentration cut-off between pathogenic mutation carriers and non-carriers of 74.8 ng/mL using the Adipogen assay based on 3301 individuals, with a CSF concentration cut-off of 3.43 ng/mL. Plasma PGRN concentration varied by GRN mutation type as well as by clinical diagnosis in those without a GRN mutation. Plasma PGRN concentration was significantly higher in women than men in GRN mutation carriers (p = 0.007) with a trend in non-carriers (p = 0.062), and there was a significant but weak positive correlation with age in both GRN mutation carriers and non-carriers. No significant association was seen with weight or with TMEM106B rs1990622 genotype. However, higher plasma PGRN levels were seen in those with the GRN rs5848 CC genotype in both GRN mutation carriers and non-carriers. CONCLUSIONS: These results further support the usefulness of PGRN concentration for the identification of the large majority of pathogenic mutations in the GRN gene. Furthermore, these results highlight the importance of considering additional factors, such as mutation type, sex and age when interpreting PGRN concentrations. This will be particularly important as we enter the era of trials for progranulin-associated FTD.

The role of hydroxyethyl starch in preventing surgical-site infections and nipple necrosis in patients undergoing reduction mammaplasty: a prospective case-control study of 334 patients.

BACKGROUND: Surgical-site infections after reduction mammaplasty are associated with poor cosmetic results. This study investigated the postoperative antiinflammatory influence of hydroxyethyl starch and its effect on surgical-site infections after breast reduction. METHODS: In this prospective case-control study, 334 patients undergoing reduction mammaplasty were prospectively assigned in a 2:1 ratio to receive either 2 × 250 ml of hydroxyethyl starch 6 % or saline solution 0.9 % for 3 days postoperatively. Patient follow-up evaluation was at least 1 month. Using uni- and multivariate analyses, this study aimed to identify risk factors for surgical-site infections and nipple necrosis. RESULTS: Surgical-site infections occurred in 6.6 % of the hydroxyethyl starch group and in 3.6 % of the control group (p = 0.704). Hydroxyethyl starch had no effect of reducing surgical-site infections [p = 0.212; odds ratio (OR), 0.317; confidence interval (CI), 0.052-1.925]. According to univariate analyses, hydroxyethyl starch reduced the occurrence of postoperative fever (p = 0.085; OR 0.608; CI 0.345-1.072), and fever was associated with increased infection rates (p = 0.033; OR 2.335; CI 1.071-5.089). Additional risk factors for postoperative infections were diabetes (p = 0.051; OR 4.051; CI 0.997-16.463) and obesity (normal weight vs grade ≥2: p = 0.003; OR 7.612; CI 2.031-28.529). Multivariate analysis showed no independent predictors for surgical-site infections. Nipple necrosis were equally observed in the two groups (p = 0.458; OR 1.643; CI 0.443-6.097). CONCLUSION: The antiinflammatory approach of hydroxyethyl starch did not lead to a decrease in infections or nipple necrosis. No difference in surgical-site infections was observed between aesthetic and oncologic procedures. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Role of Acetylsalicylic Acid in the Prevention of Pre-Eclampsia, Fetal Growth Restriction, and Preterm Birth.

BACKGROUND: Recent studies suggest that low-dose acetylsalicylic acid (ASA) can lower pregnancy-associated morbidity. METHODS: This review is based on pertinent publications that were retrieved by a selective search in PubMed, with special attention to systematic reviews, metaanalyses, and randomized controlled trials. RESULTS: Current meta-analyses document a reduction of the risk of the occurrence of pre-eclampsia (RR 0.85, NNT 50), as well as beneficial effects on the rates of preterm birth (RR 0.80, NNT 37), fetal growth restriction (RR 0.82, NNT 77), and perinatal death (RR 0.79, NNT 167). Moreover, there is evidence that ASA raises the rate of live births after a prior spontaneous abortion, while also lowering the rate of spontaneous preterm births (RR 0.89, NNT 67). The prerequisites for therapeutic success are an adequate ASA dose, early initiation of ASA, and the identification of women at risk of pregnancy-associated morbidity. Side effects of treatment with ASA in this patient group are rare and mainly involve bleeding in connection with the pregnancy (RR 0.87, NNH 200). CONCLUSION: ASA use during pregnancy has benefits beyond reducing the risk of pre-eclampsia. The indications for taking ASA during pregnancy may be extended at some point in the future; at present, in view of the available evidence, it is still restricted to high-risk pregnancies.

Assessment of Quality of Life in Gestational Diabetes Mellitus Care-Study Protocol of the GDM-QOL Project.

In recent years, the concept of quality of life (QoL) has gained significant importance within health care and clinical research, e.g., as in patient-reported outcomes. In gestational diabetes mellitus (GDM) care, enhancing QoL through reasonable interventions is considered equally important as achieving metabolic control and preventing complications in the treatment process, leading to the suggestion that QoL assessment should be implemented as a clinical standard in GDM care. Although a considerable number of questionnaires for the measurement of general as well as health-related and diabetes-specific QoL are frequently used in GDM research, a validated QoL questionnaire tailored to women with GDM does not exist in German-speaking countries. To develop and test such an instrument, we plan to conduct the following steps: (a) translate the Persian questionnaire GDMQ-36, the only GDM-specific questionnaire to date; (b) conduct expert ratings as well as pretests featuring cognitive debriefings and structured interviews with women suffering from GDM for evaluating comprehensibility, face and content validity; (c) pilot and validate the preliminary questionnaire in terms of testing its psychometric performance (e.g., via confirmatory factor analysis). The resulting GDM-specific questionnaire will facilitate a broader perspective of the pregnant women's expectations, needs, impairments, and burdens related to their disease, and its treatment. This enables physicians and other health professionals to establish an individualized treatment plan and to provide customized information, support, and psychological counseling, which helps to optimize the provided care.

Correction: Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry Number 015/025, September 2022) - Part 1 with Recommendations on the Epidemiology, Etiology, Prediction, Primary and Secondary Prevention of Preterm Birth.

[This corrects the article DOI: 10.1055/a-2044-0203.].

Correction: Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/025, September 2022) - Part 2 with Recommendations on the Tertiary Prevention of Preterm Birth and on the Management of Preterm Premature Rupture of Membranes.

[This corrects the article DOI: 10.1055/a-2044-0345.].

Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry Number 015/025, September 2022) - Part 1 with Recommendations on the Epidemiology, Etiology, Prediction, Primary and Secondary Prevention of Preterm Birth.

Aim This revised guideline was coordinated by the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (OEGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). It aims to improve the prediction, prevention, and management of preterm birth, based on evidence from the current literature, the experience of members of the guidelines commission, and the viewpoint of self-help organizations. Methods The members of the contributing professional societies and organizations developed recommendations and statements based on international literature. The recommendations and statements were presented and adopted using a formal process (structured consensus conferences with neutral moderation, written Delphi vote). Recommendations Part 1 of this short version of the guideline presents statements and recommendations on the epidemiology, etiology, prediction, and primary and secondary prevention of preterm birth.

Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/025, September 2022) - Part 2 with Recommendations on the Tertiary Prevention of Preterm Birth and on the Management of Preterm Premature Rupture of Membranes.

Aim The revision of this guideline was coordinated by the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (OEGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The aim of the guideline is to improve the prediction, prevention and management of preterm birth based on evidence from the current literature, the experience of members of the guidelines commission, and the viewpoint of self-help organizations. Methods The members of the contributing professional societies and organizations developed recommendations and statements based on international literature. The recommendations and statements were presented and adopted using a formal process (structured consensus conferences with neutral moderation, written Delphi vote). Recommendations Part 2 of this short version of the guideline presents statements and recommendations on the tertiary prevention of preterm birth and the management of preterm premature rupture of membranes.