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Purpose: As cancer survivorship increases, there is a need for simple tools to measure and promote healthy behaviors. We created a wellness behavioral tool (the SMILE Scale) to encourage self-monitoring of wellness behaviors. This study aimed to determine the feasibility of collecting daily self-reported SMILE Scale data and weekly quality of life data among patients with cancer. We also aimed to measure the association between SMILE Scale responses and validated health-related quality of life (HRQOL) tools (PROMIS-29 + 2 and SymTrak-8) as a pilot test of the hypothesis that increased wellness behaviors may impact quality of life., Methods: We surveyed 100 patients with cancer at the Indiana University Simon Comprehensive Cancer Center. Participants were asked to complete daily SMILE Scale assessments over a two-week period, as well as weekly PROMIS-29 + 2 and SymTrak-8 surveys. The primary endpoint was the SMILE Scale completion rate. Secondary endpoints in this single-arm pilot study included correlations between the SMILE Scale and other HRQOL tools., Results: Daily completion rate of the SMILE Scale ranged from 57% to 65% of participants over a 14-day period. Among the 61% of participants who completed SMILE on day 1, 87% completed SMILE on 10 of 14 days. By end of study, participants who self-reported more wellness behaviors (i.e., higher daily SMILE scores) demonstrated significantly higher PROMIS physical health (p = 0.003), higher PROMIS mental health (p = 0.008), and lower (better) SymTrak total symptom burden (p = 0.006). Further, among those who completed at least 1 of 14 daily SMILE assessments, quality of life significantly improved over the two-week period for PROMIS mental health (p = 0.018) and SymTrak total symptom burden (p = 0.014)., Conclusion: The SMILE Scale completion rate did not satisfy our pre-planned ≥70% threshold for feasibility; however, the rate for completing SMILE at least once during the 14 days (77%) met this threshold. Participants with higher average daily SMILE scores had significantly better scores across other validated HRQOL tools. While these results may be correlative and not causative, this suggests a potential physical and mental health benefit for delivering the SMILE Scale in clinical practice to help encourage healthy behaviors and warrants testing the SMILE Scale's impact in future studies., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: The aim is to investigate the risk of short-term maternal morbidity caused by the selective clinical use of episiotomy (rate < 0.02), and to compare the risk of severe perineal tears with the statewide risk., Methods: In this retrospective cohort study, we investigated the effect of selective episiotomy on the risk of severe perineal tears and blood loss in singleton term deliveries, using propensity scores with inverse probability weighting., Results: This study included 10992 women who delivered vaginally between 2008-2018. Episiotomy was performed in 171 patients (1.55%), three of whom (1.75%) experienced severe perineal tears compared to 156 (1.44%) in the control cohort. The adjusted odds ratio of severe perineal tears was 2.06 (95% confidence interval [CI]: 0.51, 8.19 with 0.3 p value). Multivariate linear regression showed that episiotomy increased blood loss by 96.3 ml (95% CI: 6.4, 186.2 with 0.03 p value). Episiotomy was performed in 23% (95% CI: 0.228, 0.23) of vaginal deliveries in the state of Hessen, with a risk of severe perineal tears of 0.0143 (95% CI: 0.0139, 0.0147) compared to 0.0145 (95% CI: 0.0123, 0.0168) in our entire cohort., Conclusions: Selective use of episiotomy does not increase the risk of higher-grade perineal tears. However, it may be associated with maternal morbidity in terms of increased blood loss.

Introduction: Epidural anesthesia is a well-established procedure in obstetrics for pain relief in labor and has been well researched as it comes to cephalic presentation. However, in vaginal intended breech delivery less research has addressed the influence of epidural anesthesia. The Greentop guideline on breech delivery states that there's little evidence and recommends further evaluation., Objective: The aim of this study was to compare maternal and neonatal outcomes in vaginally intended breech deliveries at term with and without an epidural anesthesia., Design: This study was a retrospective cohort study., Sample: This study included 2122 women at term with a singleton breech pregnancy from 37 + 0 weeks of pregnancy on and a birth weight of at least 2500 g at the obstetric department of University hospital Frankfurt from January 2007 to December 2018., Methods: Neonatal and maternal outcome was analyzed and compared between women receiving "walking" epidural anesthesia and women without an epidural anesthesia., Results: Fetal morbidity, measured with a modified PREMODA score, showed no significant difference between deliveries with (2.96%) or without (1.79%; p = 0.168) an epidural anesthesia. Cesarean delivery rates were significantly higher in deliveries with an epidural (35 vs. 26.2%, p = 0.0003), but after exclusion of multiparous women, cesarean delivery rates were not significantly different (40.2% cesarean deliveries with an epidural vs. 41.5%, p = 0.717). As compared to no epidurals, epidural anesthesia in vaginal delivery was associated with a significantly higher rate of manual assistance (33.8 versus 52.1%) and a longer duration of birth (223.7 ± 194 versus 516.2 ± 310 min) (both p < 0.0001)"., Conclusion: Epidural anesthesia can be offered as a safe option for pain relief without increasing neonatal or maternal morbidity and mortality. Nevertheless, it is associated with a longer birth duration and manually assisted delivery., (© 2023. The Author(s).)

Purpose: Obesity is a worldwide and growing issue affecting women in childbearing age, complicating surgical procedures as well as pregnancy. Through a reduction of not necessarily required cesarean deliveries-for instance in pregnancies with breech presentation-obesity mediated and surgery-associated morbidity might be contained. Date on the impact of maternal BMI in vaginally attempted breech delivery is not existing. To give insight into whether an elevated BMI leads to an increased perinatal morbidity in vaginally intended deliveries out of breech presentation, we analyzed delivery outcome of laboring women with a singleton baby in breech presentation with overweight and obesity (BMI ≥ 25 kg/m 2 ) in comparison to women with a BMI of below 25 kg/m 2 ., Methods: Based on data from January 2004 to December 2020, a cohort study was performed on 1641 women presenting with breech presentation at term (> 37 weeks). The influence of maternal BMI on perinatal outcome was analyzed with Chi 2 testing for group differences and logistic regression analysis. Patients with a hyperglycemic metabolism were excluded from the study., Results: Fetal morbidity was not different when patients with a BMI of ≥ 25 kg/m 2 (PREMODA morbidity score 2.16%) were compared to patients with a BMI of below 25 kg/m 2 (1.97%, p = 0.821). Cesarean delivery rates were significantly higher in overweight and obese women with 43.9% compared to 29.3% (p < 0.0001). BMI and cesarean delivery were significantly associated in a logistic regression analysis (Chi 2 coefficient 18.05, p < 0.0001). In successful vaginal deliveries out of breech presentation, maternal perineal injury rates (vaginal birth in normal-BMI women 48.4%; vaginal birth in overweight and obese women: 44.2%; p = 0.273) and rates of manually assisted delivery (vaginal birth in normal-BMI women: 44.4%; vaginal birth in obese and overweight women: 44.2%; p = 0.958) were not different between BMI groups., Conclusions: Obesity and overweight are not associated with peripartum maternal or newborn morbidity in vaginally attempted breech delivery, if the patient cohort is thoroughly selected and vaginal breech delivery is in an upright maternal position. Reduction of cesarean delivery rates, especially in overweight and obese women might, have an important positive impact on maternal and newborn morbidity., (© 2024. The Author(s).)

Background: The ex-utero intrapartum treatment (EXIT) allows to ensure fetal airway while keeping uteroplacental circulation. However, EXIT may become a life-threatening procedure due to the increased risk of uterine atony or placenta abruption with increased peripartum blood losses and increased transfusion rates. We aim to review maternal anemia prevalence and transfusion requirements in women undergoing EXIT procedure., Methods: Using data from the Federal German Statistical Office hospitalized women undergoing EXIT procedure between January 1st 2006 and December 31st 2021 were included. The prevalence of anemia, peripartum hemorrhage, comorbidities and administration of red blood cells (RBC) were analyzed., Results: In total, 72 women underwent EXIT procedure with a median age of 31 years (26;33.5). In 43.1% EXIT was conducted at 34-36 weeks of gestational age. "Anemia during pregnancy" was present in 47.2%, "anemia due to acute bleeding" in 25.0% and "iron deficiency anemia" in 15.3%. Postpartum hemorrhage occurred in 11.1%. RBCs were transfused in 15.3% of all women. Most women required 1-5 units of RBCs., Conclusion: Despite the rarity of this procedure, anemia management and blood conservation strategies in order to reduce the need for RBC transfusion are highly important in women undergoing EXIT procedure., Competing Interests: KZ has received honoraria for participation in advisory board meetings for Haemonetics and Vifor and received speaker fees from CSL Behring, Masimo, Pharmacosmos, Boston Scientific, Salus, iSEP, Edwards, and GE Healthcare, the Principal Investigator of the EU-Horizon 2020 project ENVISION (Intelligent plug-and-play digital tool for real-time surveillance of COVID-19 patients and smart decision-making in Intensive Care Units) and Horizon Europe 2021 project COVend (Biomarker and AI-supported FX06 therapy to prevent progression from mild and moderate to severe stages of COVID-19), and leads as CEO the Christoph Lohfert Foundation as well as the Health, Patient Safety and PBM Foundation. JK and BF are Deputy Principal Investigator of ENVISION and COVend. VN received honoraria for lectures and travel expenses from Sysmex, Pharmacosmos, MCN congress organization, and support for publication costs from the Goethe University Frankfurt. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Kloka, Jasny, Jennewein, Friedrichson, Zacharowski and Neef.)

Purpose: In order to spread competence in vaginal breech deliveries, it is necessary to develop new and easily applicable tools for birth progression and safety evaluation. Ultrasound is a useful and ubiquitously available tool with already documented value for birth progression observation. In deliveries out of breech presentation, an established ultrasound examination is missing. We determined the descent of the fetal buttocks in relation to the maternal pelvic inlet using intrapartum ultrasound. We evaluated these results in comparison to the clinical vaginal examination with the aim to establish an easily applicable method for birth outcome prediction. Therefore, we analyzed the predictive value of our examinations on birth outcome parameters, such as cesarean section rate, as well as fetal and maternal outcome parameters., Methods: We performed a prospective blinded study on 106 mothers with vaginally intended breech delivery. At beginning of stage two in labor, the descent of the fetal buttocks into the mother's pelvic inlet was detected with transabdominal ultrasound and vaginal examination by different observers., Primary Outcome Variable: Cesarean section rate. Secondary outcome variables: rate of manual assistance in vaginal deliveries, birth duration, 5' APGAR score, umbilical arterial pH, maternal blood loss, and perineal injury. For non-parametric values, Wilcoxon's χ 2 test was performed. In order to analyze the predictive value of our examination, lack-of-fit analysis was conducted. Reliability evaluation of the sonographic examination was done with a matched-pair analysis., Results: Women with positive intrapartum ultrasound breech engagement sign (+ IPUBES) had a significantly lower rate of cesarean section in comparison with those with negative IPUBES (5/67; 7.5% vs. 18/39; 46.2%; p < 0.0001). The area under the ROC curve for the prediction of CS for negative IPUBES was 0.765 with a sensitivity of 78.3% and a specificity of 74.7%. Sonographic examination showed an excellent reliability in a matched-pair analysis comparing vaginal and sonographic examinations with a mean difference of 0.012 (SD ± 0.027, 95% CI - 0.014 to 0.065). Mean birth duration was significantly longer in deliveries with negative IPUBES (533 min vs. 440 min; p = 0.0011). Fetal and maternal outcome parameters were not significantly different between deliveries with positive and negative IPUBES., Conclusions: Sonographic evaluation of the fetal descent in relation to the mother's pelvic inlet screens reliably for emergency cesarean section. This newly presented method for birth progression observation might be a powerful tool for distribution of expertise in vaginal breech delivery and is able to give reference for clinical vaginal examination by obstetricians in training., Trail Registry: Clinical trial. Date of registration: 13.03.2019; Date of initial participant enrollment: 20.03.2019; DRKS00016885; https://www.drks.de ; German clinical trials register., (© 2023. The Author(s).)

Background: Placenta accreta spectrum (PAS) disorders are a continuum of placental pathologies with increased risk for hemorrhage, blood transfusion and maternal morbidity. Uterine artery embolization (UAE) is a safe approach to the standardization of complex PAS cases. The aim of this study is to analyze anemia and transfusion rate, outcome and anesthesiological management of women who underwent caesarean delivery with subsequent UAE for the management of PAS., Material and Methods: This retrospective observational study included all pregnant women admitted to the University Hospital Frankfurt between January 2012 and September 2023, with a diagnosis of PAS who underwent a two-step surgical approach for delivery and placenta removal. Primary procedure included cesarean delivery with subsequent UAE, secondary procedure included placenta removal after a minim of five weeks via curettage or HE. Maternal characteristics, anesthesiological management, complications, anemia rate, blood loss and administration of blood products were analyzed., Results: In total, 17 women with PAS were included in this study. Of these, 5.9% had placenta increta and 94.1% had placenta percreta. Median blood loss was 300 (200-600) mL during primary procedure and 3600 (450-5500) mL during secondary procedure. In total, 11.8% and 62.5% of women received red blood cell transfusion during the primary and secondary procedures, respectively. After primary procedure, postpartum anemia rate was 76.5%. The HE rate was 64.7%. Regional anesthesia was used in 88.2% during primary procedure., Conclusion: The embolization of the uterine artery for women diagnosed with PAS is safe. Anemia management and the implementation of blood conservation strategies are crucial in women undergoing UAE for the management of PAS.

Background: The epidural catheter for analgesia has been used for decades and has become the gold standard in pain therapy for pregnant women in labour. However, procedural parameters such as time to pain relief and duration to implementation pose hurdles for patients shortly before delivery. Low-dose spinal analgesia (LDSA) is an alternative procedure that was investigated in the study with regard to patient satisfaction and complication rates compared to epidural catheter., Methods: In a retrospective monocentric study, a total of 242 patients receiving low-dose spinal analgesia or epidural catheters were evaluated using propensity score matching. Subjective patient satisfaction as well as complication rates were primarily analysed. We hypothesise that LDSA is a safe procedure and provides a similar level of satisfaction compared with the epidural catheter. For this purpose, both procedures were performed according to in-house standards and the patients were interviewed afterwards. Patients who required surgical delivery were excluded to prevent bias., Results: The LDSA was rated on average as very good [1.09 ± 0.311 vs. 1.07 ± 0.431] in terms of satisfaction by the patients compared to the epidural catheter without showing a significant difference ( p = 0.653). Complications were in the low single-digit non-significant range for both procedures [6 (5%) vs. 7 (6%); p = 0.776]. The evaluation showed more perineal tears I° and II° in the low-dose spinal analgesia group [I°: 28 (23%) vs. 3 (2%); p < 0.001-II°: 30 (25%) vs. 2 (2%); p < 0.001]. Neonatal parameters differed significantly only in umbilical cord base excess and umbilical cord venous pH [-5.40 vs. -6.40; p = 0.005]., Conclusions: LDSA represents a low complication procedure for patients at the end of labour with a high satisfaction level. With the LDSA in the repertoire of pain relief during childbirth, it is possible to also achieve pain reduction for women with deliveries of high velocity without compromising patient satisfaction or perinatal morbidity.

Objective This S2k guideline of the German Society for Gynecology and Obstetrics (DGGG) and the German Society of Perinatal Medicine (DGPM) contains consensus-based recommendations for the care and treatment of pregnant women, parturient women, women who have recently given birth, and breastfeeding women with SARS-CoV-2 infection and their newborn infants. The aim of the guideline is to provide recommendations for action in the time of the COVID-19 pandemic for professionals caring for the above-listed groups of people. Methods The PICO format was used to develop specific questions. A systematic targeted search of the literature was carried out using PubMed, and previously formulated statements and recommendations issued by the DGGG and the DGPM were used to summarize the evidence. This guideline also drew on research data from the CRONOS registry. As the data basis was insufficient for a purely evidence-based guideline, the guideline was compiled using an S2k-level consensus-based process. After summarizing and presenting the available data, the guideline authors drafted recommendations in response to the formulated PICO questions, which were then discussed and voted on. Recommendations Recommendations on hygiene measures, prevention measures and care during pregnancy, delivery, the puerperium and while breastfeeding were prepared. They also included aspects relating to the monitoring of mother and child during and after infection with COVID-19, indications for thrombosis prophylaxis, caring for women with COVID-19 while they are giving birth, the presence of birth companions, postnatal care, and testing and monitoring the neonate during rooming-in or on the pediatric ward., Competing Interests: Conflict of Interest/Interessenkonflikt The authorsʼ conflicts of interest are listed in the long version of the guideline./Die Interessenkonflikte der Autoren sind in der Langfassung der Leitlinie aufgelistet., (Thieme. All rights reserved.)

(1) Background: Guidelines on vaginal breech delivery require birth weight restrictions and neglect the impact of pelvic measurements despite contradicting evidence. There is a great need for more evidence on delivery outcome predicting factors for patients counselling. (2) Methods: We performed a prospective cohort study on 748 primiparous women intending vaginal breech birth and analyzed combined influence of fetal birth weight (BW) and the obstetric conjugate (conjugate vera obstetrica, CVO) on delivery outcome. (3) Results: We generated a BW/CVO ratio and devided our study cohort at median (257.8 g/cm) into a low ratio group (LR, with low birth weight and wide obstetric conjugate) and a high ratio group (HR, high birth weight and narrow obstetric conjugate). Cesarean section (CS) rate was significantly higher in HR (50.3%) as compared to LR (28.3%, p < 0.0001). Fetal morbidity was not different. In vaginally completed deliveries duration of birth was significantly longer in vHR (557 min) as in vLR (414 min, p < 0.001). Manual assistance to deliver the arms (‘Louwen maneuver’) positively correlated with birth weight (r2 = 0.215; p = 0.005) and the BW/CVO ratio (r2 = 0.0147; p = 0.02). (4) Conclusions: A high fetal birth weight combined with a tiny CVO predicts higher cesarean section probability, longer birth duration and the necessity to perform arm delivery assistance. Birth weight and pelvic measurements should be topics of great importance in patients counselling.

Objective: To assess the effect of cesarean section (CS) timing, elective versus unplanned, on the residual myometrial thickness (RMT) and CS scars., Methods: This is a prospective single-blinded observational cohort study with 186 observations. Patients indicated to undergo first singleton CS were preoperatively recruited. Exclusion criteria were history of repeated CS, vertical hysterotomy, diabetes, and additional uterine surgeries. Sonographic examination was performed for assessing the RMT ratio, the presence of a niche, fibrosis, and the distance from the scar to the internal os (SO) 1 year after CS. Power analysis was performed with 0.05 α, 0.1 β, and all statistical analyses were conducted with Stata ® ., Results: Wilcoxon rank-sum test for the association between CS timing, RMT ratio and SO showed Z values of -0.59 and -4.94 (P = 0.553 and P < 0.001), respectively. There was no association between CS timing and niches and fibrosis (P > 0.99 and P = 0.268, respectively). Linear regression between SO and the extent of cervical dilatation showed a -0.45 β (95% confidence interval -0.68 to -0.21) and a 10.22-mm intercept (P < 0.001)., Conclusion: RMT is independent of the timing of CS, but the SO distance shows a negative linear relationship with the cervical dilatation., (© 2021 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Introduction: Cesarean section (CS) rates are increasing worldwide. One constant indication is the breech presentation at term. By offering external cephalic version (ECV) and vaginal breech delivery CS rates can be further reduced., Objective: This study aimed to analyze the ECV at 38 weeks of gestation with the associate uptake rate, predicting factors, success rate, and complications at a tertiary healthcare provider in Germany specializing in vaginal breech delivery., Methods: We conducted a prospective cohort study with retrospective data acquisition. All women with a singleton fetus in breech presentation presenting after 34 weeks of gestation for counseling between 2013 and 2017 were included. ECV impact factors were analyzed using logistic regression., Results: A total of 1,598 women presented for breech birth planning. ECV was performed on 353 patients. The overall success rate was 22.4%. A later week of gestation (odds ratio [OR] 1.69), an abundant amniotic fluid index (AFI score) (OR 5.74), fundal (OR 3.78) and anterior (OR 0.39) placental location, and an oblique lie (OR 9.08) were significantly associated with successful ECV in our population. No major complications were observed. The overall vaginal delivery rates could be increased to approximately 14% with ECV., Conclusion: The demand for alternative birth modes other than CS for breech birth is high in the area of Frankfurt, Germany. Our study offers evidence of the safety of ECV at 38 weeks. Centers with expertise in vaginal breech delivery and ECV can reduce CS-rates. To further establish vaginal breech delivery and ECV as alternate options, the required knowledge and skill should be implemented in the revised curricula., Competing Interests: Prof. Frank Louwen is first vice president of the German Society for Gynaecology and Obstetrics (DGGG), council member of the European Board and College of Obstetrics and Gynaecology (EBCOG) and Executive Board Member und Committee chairman of the International Federation of Gynecology and Obstetrics (FIGO). Prof. Frank Louwen und Dr. Cover Letter Lukas Jennewein worked on the first German S3-Guideline for cesarean section published in 2020. Ann-Sophie Zielbauer declares no relevant conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Preeclampsia (PE), a gestational hypertensive disease originating from the placenta, is characterized by an imbalance of various cellular processes. The cell cycle regulator p21 Cip1/ CDKN1A (p21) and its family members p27 and p57 regulate signaling pathways fundamental to placental development. The aim of the present study was to enlighten the individual roles of these cell cycle regulators in placental development and their molecular involvement in the pathogenesis of PE. The expression and localization of p21, phospho-p21 (Thr-145), p27, and p57 was immunohistochemically analyzed in placental tissues from patients with early-onset PE, early-onset PE complicated by the HELLP (hemolysis, elevated liver enzymes and low platelet count) syndrome as well as late-onset PE compared to their corresponding control tissues from well-matched women undergoing caesarean sections. The gene level was evaluated using real-time quantitative PCR. We demonstrate that the delivery mode strongly influenced placental gene expression, especially for CDKN1A (p21) and CDKN1B (p27), which were significantly upregulated in response to labor. Cell cycle regulators were highly expressed in first trimester placentas and impacted by hypoxic conditions. In support of these observations, p21 protein was abundant in trophoblast organoids and hypoxia reduced its gene expression. Microarray analysis of the trophoblastic BeWo cell line depleted of p21 revealed various interesting candidate genes and signaling pathways for the fusion process. The level of p21 was reduced in fusing cytotrophoblasts in early-onset PE placentas and depletion of p21 led to reduced expression of fusion-related genes such as syncytin-2 and human chorionic gonadotropin (β-hCG), which adversely affected the fusion capability of trophoblastic cells. These data highlight that cell cycle regulators are important for the development of the placenta. Interfering with p21 influences multiple pathways related to the pathogenesis of PE.

Purpose This is an official S3-guideline of the German Society of Gynaecology and Obstetrics (DGGG), the Austrian Society of Gynaecology and Obstetrics (ÖGGG) and the Swiss Society of Gynaecology and Obstetrics (SGGG). The guideline contains evidence-based information and recommendations on indications, complications, methods and care associated with delivery by caesarean section for all medical specialties involved as well as for pregnant women. Methods This guideline has adapted information and recommendations issued in the NICE Caesarean Birth guideline. This guideline also considers additional issues prioritised by the Cochrane Institute and the Institute for Research in Operative Medicine (IFOM). The evaluation of evidence was based on the system developed by the Scottish Intercollegiate Guidelines Network (SIGN). A multi-part nominal group process moderated by the AWMF was used to compile this S3-level guideline. Recommendations Recommendations on consultations, indications and the process of performing a caesarean section as well as the care provided to the mother and neonate were drawn up., Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest are listed in the guidelineʼs Guideline Report./Interessenkonflikte sind im Dokument „Leitlinienreport“ der Leitlinie aufgeführt., (Thieme. All rights reserved.)

Doppler examination of the umbilical artery and the fetal middle cerebral artery is evaluated predominantly in pregnancies with fetuses in cephalic presentation and never has been elucidated in breech presentation. Evidence on the accuracy of fetal weight estimation in dependence of the fetal presentation is controversial. Nevertheless, clinical decisions including recommendations for a cesarean section or labor induction based on these examinations are applied to pregnancies with fetuses in breech presentation. The objective of this study was to investigate the influence of the fetal presentation on fetal weight estimation accuracy, umbilical artery and middle cerebral artery resistance indices (RI) in a prospective case control study. Ultrasound examinations in 305 uncomplicated term pregnancies (153 vertex presentations, 152 breech) were investigated. Non-parametric variables were compared using Pearson's chi 2 test and Wilcoxon chi 2 test, depending on variable scaling. Fetal weight estimation accuracy was not significantly different between vertex presentation group (VP) (6.97%) and breech presentation group (BP) (7.96%, p = 0.099). Fetal head circumference measurements were significantly larger in BP (350 mm vs. 341 mm in VB, p > 0.0001) while abdominal circumferences were significantly smaller (VP: 338 mm, BP: 331 mm, p = 0.0039) and weight estimation was not significantly different. Umbilical artery RIs were not significantly different between VP (54.5) and BP (55.3, p = 0.354). Fetal middle cerebral artery RIs also showed no significant differences (VP: 71.2, BP: 70.7, p = 0.335). Our study shows that fetal Doppler (RI) and weight estimation ultrasound originally calibrated in cephalic pregnancies are applicable to pregnancies with fetuses in breech presentation.

Background: Acute bleeding requires fast and targeted therapy. Therefore, knowledge of the patient's potential to form a clot is crucial. Point-of-care testing (POCT) provides fast and reliable information on coagulation. Structural circumstances, such as person-bound sample transport, can prolong the reporting of the results. The aim of the present study was to investigate the diagnostic quality and accuracy between POCT INR diagnostics and standard laboratory analysis (SLA) as well as the time advantage between a pneumatic tube and a personal-based transport system., Methods: Two groups of haemorrhagic patients (EG: emergency department; OG: delivery room; each n = 12) were examined in the context of bleeding emergencies using POCT and SLA. Samples were transported via a pneumatic tube system or by a personal transport service., Results: INR results between POCT and SLA showed a high and significant correlation (EG: p < 0.001; OG: p < 0.001). POCT results were reported significantly more quickly (EG: 1.1 vs. 39.6 min; OG: 2.0 vs. 75.0 min; p < 0.001) and required less time for analysis (EG: 0.3 vs. 24.0 min; OG: 0.5 vs. 45.0 min; p < 0.001) compared to SLA. The time for transportation with the pneumatic tube was significantly shorter (8.0 vs. 18.5 min; p < 0.001) than with the personal-based transport system., Conclusion: The results of the present study suggest that POCT may be a suitable method for the emergency diagnosis and may be used as prognostic diagnostic elements in haemotherapy algorithms to initiate targeted haemotherapy at an early point in time., Competing Interests: KZ: Received speaker honoraria from B. Braun, Melsungen, Germany. All other authors declare no conflicts of interests., (© 2021 Published by Elsevier B.V.)

Background: Vaginal breech delivery is becoming an extinct art although national guidelines underline its safety and vaginal breech delivery in an upright position has been shown to be a safe birth mode option. In order to spread clinical knowledge and be able to implement vaginal breech delivery into obstetricians' daily practice, we need to gather knowledge from facilities who teach specialized obstetrical management., Methods: We performed a prospective cohort study on 140 vaginal deliveries out of breech presentation solely-managed by seven newly-trained physicians and compared fetal outcome as well as rates of manual assistance in respect to preexisting experience., Results: Fetal morbidity rate measured with a modified PREMODA score was not significantly different in three sub-cohorts sorted by preexisting expertise levels of managing obstetricians (experience groups EG, EG0: 2, 5%; EG1: 3, 7.5%; EG2: 1, 1.7%; p = 0.357). Manual assistance rate was significantly higher in EG1 (low experience level in breech delivery and only in dorsal position) compared to EG0 and EG2 (EG1 28, 70%; EG0: 14, 25%; EG2: 21, 35%; p = 0.0008)., Conclusions: Our study shows that vaginal breech delivery with newly-trained obstetricians is a safe option whether or not they have advanced preexisting expertise in breech delivery. These data should encourage implementing vaginal breech delivery in clinical routine.

Introduction: The best way to deliver a term breech infant is still a much discussed topic among obstetricians. The question whether nulliparity should be considered an exclusion criterion for an intended vaginal breech delivery is not fully answered., Objective: We compared maternal and neonatal outcome of intended vaginal breech deliveries of nulliparous versus multiparous women at term., Study Design: We conducted a prospective case-control study between January 2004 and December 2016. 1046 women expecting singletons at term with favorable pelvic measurements were enrolled in the study., Results: Neonatal morbidity and mortality was not significantly different in deliveries of nulliparous (n = 647) versus multiparous (n = 399) women. Nulliparous women had a significantly higher rate of a cesarean section during labor than multiparous women. Maternal birth-injury rates and the use of epidural anesthesia were significantly higher comparing vaginal births of nulliparous (n = 384) versus multiparous (n = 331) women., Conclusion: Nulliparity seems not be an exclusion criterion for intended vaginal breech birth at term. It is still important to inform the women of an increased risk of a cesarean section during labor. A clinical management built on this evidence might reduce negative implications for future pregnancies., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: 3-4% of pregnant women present with a fetal breech position at term. National societies regard vaginal breech delivery as a safe option, but only for a specific and thoroughly counseled group of patients. To avoid adverse outcome, many practitioners recommend elective cesarean section once their patients go past the estimated due date. Since encompassing evidence is missing, the evaluation on this common clinical practice is needed., Objective: This study compares the short-term maternal and fetal outcome in intended vaginally breech deliveries before the estimated due date (until 40 0/7 weeks of gestation) to the outcome of deliveries carried out past the estimated due date (later than 40 0/7 weeks of gestation)., Methods: This prospective cohort study includes 827 women who presented for an intended vaginal breech delivery of a singleton at our perinatal center between January 2010 and December 2016., Results: 447 patients (54%) delivered before or at their estimated due date, 380 (46%) of pregnancies continued after the estimated due date. Comparing both groups, no significant difference in maternal and neonatal short-term mortality and morbidity was found. The rate of caesarian sections was increased in the group of patients, who delivered later than 40 1/7 weeks of gestation. Here, the likelihood for delivery maneuvers was also increased., Conclusion: This study provides evidence, that an elective cesarean section for breech presentations at term is not obligatory when the estimated due date has passed in singleton pregnancy., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: Vaginal delivery out of a breech presentation in pregnancies at term are being re-implemented into clinical practice. Still, recommendations regarding exclusion criteria leading to caesarean sections are based on expert opinions, not on evidence-based guidelines. The difference in perinatal outcome and course of delivery in births with babies in frank breech position and babies in incomplete or complete breech presentation never has been investigated in a large patient cohort., Objective: To compare perinatal outcome of vaginally intended breech deliveries between births out of frank breech position and incomplete/complete breech presentation., Design: Prospective cohort study., Sample: 884 women at term with a singleton in frank breech presentation (FB) and 284 women with incomplete or complete breech presentation (CB) intending vaginal birth between January 2004 and December 2018., Methods: Maternal and fetal outcome was compared between groups using Pearson's Chi Square test. Birth duration parameters were analysed using logistic regression., Results: There were no differences in cesarean section rates (FB: 25.1%, CB 22.2%, p = 0.317). Short-term fetal morbidity did not differ between groups (FB: 2.5%, CB: 2.8%, p = 0.761). In vaginal deliveries the necessity to perform manual assistance was significantly more frequent in deliveries of infants in CB (FB: 39.9%, CB: 51.6%, p = 0.0013). Cord loops (FB: 10.1%, CB: 18.0%, p = 0.0004) and cesarean sections necessary because of cord prolapses (FB: 1.4%, CB 8.1%, p = 0.005) were significantly more often in deliveries with babies in CB., Conclusion: This study provides evidence, that perinatal morbidity is not associated with the fetal leg posture in vaginally intended breech deliveries. The higher risk for the need of manual assistance during vaginal birth in deliveries of babies out of complete or incomplete breech presentation suggests that obstetrical departments re-implementing the vaginal breech in their repertoire might start with births of babies out of frank breech presentation., Competing Interests: The authors have declared that no competing interests exist.

Background: Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction., Methods: The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes)., Discussion: This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users' motivation. Insights gained from this study can inform other patient safety interventions and health policy developments., Trial Registration: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019.

Preeclampsia (PE) remains a leading cause of maternal and perinatal mortality and morbidity worldwide. Its pathogenesis has not been fully elucidated and no causal therapy is currently available. It is of clinical relevance to decipher novel molecular biomarkers. RITA ( R BP-J (recombination signal binding protein J)- i nteracting and t ubulin- a ssociated protein) has been identified as a negative modulator of the Notch pathway and as a microtubule-associated protein important for cell migration and invasion. In the present work, we have systematically studied RITA's expression in primary placental tissues from patients with early- and late-onset PE as well as in various trophoblastic cell lines. RITA is expressed in primary placental tissues throughout gestation, especially in proliferative villous cytotrophoblasts, in the terminally differentiated syncytiotrophoblast, and in migrating extravillous trophoblasts. RITA 's messenger RNA (mRNA) level is decreased in primary tissue samples from early-onset PE patients. The deficiency of RITA impairs the motility and invasion capacity of trophoblastic cell lines, and compromises the fusion ability of trophoblast-derived choriocarcinoma cells. These data suggest that RITA may play important roles in the development of the placenta and possibly in the pathogenesis of PE., Competing Interests: The authors declare no conflict of interest. The funders had no role in the study design; in collection, analyses, or interpretation of data; in manuscript writing, or in the decision to publish the results.

Background: Breast cancer (BC) is the most frequent malignant tumor in females and the 2nd most common cause of brain metastasis (BM), that are associated with a fatal prognosis. The increasing incidence from 10% up to 40% is due to more effective treatments of extracerebral sites with improved prognosis and increasing use of MRI in diagnostics. A frequently administered, potent chemotherapeutic group of drugs for BC treatment are taxanes usually used in the adjuvant and metastatic setting, which, however, have been suspected to be associated with a higher incidence of BM. The aim of our study was to experimentally analyze the impact of the taxane docetaxel (DTX) on brain metastasis formation, and to elucidate the underlying molecular mechanism., Methods: A monocentric patient cohort was analyzed to determine the association of taxane treatment and BM formation. To identify the specific impact of DTX, a murine brain metastatic model upon intracardial injection of breast cancer cells was conducted. To approach the functional mechanism, dynamic contrast-enhanced MRI and electron microscopy of mice as well as in-vitro transendothelial electrical resistance (TEER) and tracer permeability assays using brain endothelial cells (EC) were carried out. PCR-based, immunohistochemical and immunoblotting analyses with additional RNA sequencing of murine and human ECs were performed to explore the molecular mechanisms by DTX treatment., Results: Taxane treatment was associated with an increased rate of BM formation in the patient cohort and the murine metastatic model. Functional studies did not show unequivocal alterations of blood-brain barrier properties upon DTX treatment in-vivo, but in-vitro assays revealed a temporary DTX-related barrier disruption. We found disturbance of tubulin structure and upregulation of tight junction marker claudin-5 in ECs. Furthermore, upregulation of several members of the tubulin family and downregulation of tetraspanin-2 in both, murine and human ECs, was induced., Conclusion: In summary, a higher incidence of BM was associated with prior taxane treatment in both a patient cohort and a murine mouse model. We could identify tubulin family members and tetraspanin-2 as potential contributors for the destabilization of the blood-brain barrier. Further analyses are needed to decipher the exact role of those alterations on tumor metastatic processes in the brain.

Background: Obesity impairs a variety of cell types including adipose-derived mesenchymal stem cells (ASCs). ASCs are indispensable for tissue homeostasis/repair, immunomodulation, and cell renewal. It has been demonstrated that obese ASCs are defective in differentiation, motility, immunomodulation, and replication. We have recently reported that some of these defects are linked to impaired primary cilia, which are unable to properly convey and coordinate a variety of signaling pathways. We hypothesized that the rescue of the primary cilium in obese ASCs would restore their functional properties., Methods: Obese ASCs derived from subcutaneous and visceral adipose tissues were treated with a specific inhibitor against Aurora A or with an inhibitor against extracellular signal-regulated kinase 1/2 (Erk1/2). Multiple molecular and cellular assays were performed to analyze the altered functionalities and their involved pathways., Results: The treatment with low doses of these inhibitors extended the length of the primary cilium, restored the invasion and migration potential, and improved the differentiation capacity of obese ASCs. Associated with enhanced differentiation ability, the cells displayed an increased expression of self-renewal/stemness-related genes like SOX2, OCT4, and NANOG, mediated by reduced active glycogen synthase kinase 3 β (GSK3β)., Conclusion: This work describes a novel phenomenon whereby the primary cilium of obese ASCs is rescuable by the low-dose inhibition of Aurora A or Erk1/2, restoring functional ASCs with increased stemness. These cells might be able to improve tissue homeostasis in obese patients and thereby ameliorate obesity-associated diseases. Additionally, these functionally restored obese ASCs could be useful for novel autologous mesenchymal stem cell-based therapies.

Objective: To assess the effect of a 5-hydroxytryptamine-3 receptor antagonist (granisetron) on the use of sympathomimetic (cafedrine/theodrenaline) and uterotonic (oxytocin) agents after spinal anesthesia during cesarean delivery., Methods: A retrospective observational analysis was conducted using intraoperative records (n=240) created at a single hospital in Germany between November 1, 2016, and July 31, 2017. The granisetron group (n=120) had received 3 mg of granisetron immediately before induction of spinal anesthesia. The control group (n=120) had not received granisetron. The primary endpoints were the intraoperative requirements for sympathomimetic and uterotonic agents. The secondary endpoints were parameters of intraprocedural maternal hemodynamic and clinical states., Results: More patients in the granisetron group than in the control group received intraoperative cafedrine/theodrenaline (P=0.045), with the cumulative intraoperative dosage also increased in the granisetron group (P=0.016). By contrast, the cumulative intraoperative dose of oxytocin was lower in the granisetron group than in the control group (P<0.001). Decreases in heart rate and mean arterial blood pressure were lower in the granisetron group versus the control group (P=0.015 and P=0.002, respectively)., Conclusion: Treatment with granisetron immediately before cesarean delivery did not reduce the perioperative requirement for sympathomimetics but did reduce the need for uterotonics. REGISTERED AT CLINICALTRIALS.GOV (NCT03318536)., (© 2019 International Federation of Gynecology and Obstetrics.)

Background: Postpartum hemorrhage is the leading cause of maternal death. Recently, the WOMAN trial showed that early administration of tranexamic acid leads to a reduced mortality due to bleeding. The aim was to study whether the results of the WOMAN trial have influenced the institutional standard operating procedures in treating postpartum hemorrhage., Methods: We performed a paper-based survey during the German Perinatal Congress in 2017 located in Berlin. A total of thirteen questions covered the fields of incidence, training, and treatment of postpartum hemorrhage., Results: 250 questionnaires were handed out to all participants of three different sessions during the congress. 72 questionnaires were returned, resulting in a return rate of 29%. 94% (n = 65) of all participants stated that they had implemented a standard operating procedure to treat postpartum hemorrhage prior to the WOMAN trial. 18 of these standard operating procedures were revised after the publication of the WOMAN trial, resulting in an early inclusion of tranexamic acid in 100% of all standard operating procedures., Conclusion: We recognized a correlation between the publication of the WOMAN trial and the administration of tranexamic acid at an early time-point in all standard operating procedures of the participating institutions to treat postpartum hemorrhage. In all those clinics whose algorithms initially did not contain any tranexamic acid, it was supplemented. This resulted in a 100% implementation of tranexamic acid., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Introduction: The clinical management of breech presentations at term is still a controversially discussed issue among clinicians. Clear predictive criteria for planned vaginal breech deliveries are desperately needed to prevent adverse fetal and maternal outcomes and to reduce elective cesarean section rates. The green-top guideline considers an estimated birth weight of 3.8 kg or more an indication to plan a cesarean section despite the lack of respective evidence., Objective: To compare maternal and neonatal outcome of vaginal intended breech deliveries of births with children with a birth weight of 2.5 kg- 3.79 kg and children with a birth weight of 3.8 kg and more., Design: Prospective cohort study., Sample: All vaginal intended deliveries out of a breech position of newborns weighing between 2.5 kg and 4.5 kg at the Obstetrics department at Goethe University Hospital Frankfurt from January 2004 until December 2016., Methods: Neonatal and maternal outcome of a light weight group (LWG) (< 3.8 kg) was compared to and a high weight group (HWG) (≥ 3.8 kg) using Pearson's Chi Square test and Fishers exact test. A logistic regression analysis was performed to detect an association between cesarean section rates, fetal outcome and the birth weight., Results: No difference in neonatal morbidity was detected between the HWG (1.8%, n = 166) and the LWG (2.6%, n = 888). Cesarean section rate was significantly higher in the HWG with 45.2% in comparison to 28.8% in the LWG with an odds ratio of 1.57 (95% CI 1.29-1.91, p<0.0001). In vaginal deliveries, a high birth weight was not associated with an increased risk of maternal birth injuries (LWG in vaginal deliveries: 74.3%, HWG in vaginal deliveries: 73.6%; p = 0.887; OR = 1.9 (95% CI 0.9-1.1))., Conclusion: A fetal weight above 3.79 kg does not predict increased maternal or infant morbidity after delivery from breech presentation at term. Neither the literature nor our analyses document evidence for threshold of estimated birth weight that is associated with maternal and/or infant morbidity. However, patients should be informed about an increased likelihood of cesarean sections during labor when attempting vaginal birth from breech position at term in order to reach an informed shared decision concerning the birth strategy. Further investigations in multi center settings are needed to advance international guidelines on vaginal breech deliveries in the context of estimated birth weight and its impact on perinatal outcome., Competing Interests: The authors have declared that no competing interests exist.

Testicular germ cell cancer in a metastatic state is curable with a cisplatin-based first line chemotherapy. However, 10-15% of these patients are resistant to first line chemotherapy and are thus left with only palliative options. Immunotherapies and inhibition of angiogenesis used in multiple types of cancer; however, the molecular context of angiogenesis and immune checkpoints in the development and progression of testicular cancers is still unknown. Therefore, the present study performed tissue micro array based analysis of 84 patients with immunohistochemistry of programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1) and vascular endothelial growth factor receptor 2 (VEGFR2) of testicular cancer and corresponding normal appearing testis tissue, matching the results with clinical data. The results demonstrated that PD-L1 was significantly upregulated in testicular tumors and that PD-1 positive cells significantly infiltrated the testicular tumor when compared with normal testicular tissue. VEGFR2 was significantly upregulated in testicular cancer. It was indicated that PD-1 expressing cytotoxic cells may require pathologic tumor vessels to pass the blood-testis-barrier in order to migrate into the tumor. Notably, when matching the clinical data for PD-1, PD-L1 and VEGFR2 there were no differences in expression in the different International Germ Cell Cancer Collaborative Group stages of non-seminoma. These data suggested that the anti-PD-1/PD-L1 immunotherapy and the anti-angiogenic therapy, sequentially or in combination, may be a promising option in the treatment of testicular cancer.