Geburtshilfe Und Frauenheilkunde最新文献

Introduction Monotherapy with progesterone for treatment of vasomotor symptoms (VMS) was more effective than placebo treatment of postmenopausal healthy women in a Canadian trial. The PROGEST-trial was initiated to fulfill FDA-approval criteria for the indication of treatment of postmenopausal VMS. Methods This prospective randomized, double-blind placebo-controlled clinical trial studied three doses of oral micronized progesterone (200 mg, 300 mg, 400 mg) and placebo for 12 weeks. Postmenopausal women with moderate to severe VMS (> 50 per week) were screened for one week for VMS frequency, then randomized to 200, 300 or 400 mg progesterone daily or placebo for a double-blinded trial of 12 weeks duration. Results 74 women were recruited in 12 study centers. 44 terminated the study as per protocol (PP). Moderate to severe hot flushes decreased by 7.4/d in the placebo arm, 7.7 VMS/d with 200 mg/d progesterone (P4), 8.3 VMS/d on 300 mg/d and 9.0 VMS/d on 400 mg/d P4, respectively by week 12. 32 treatment emergent adverse events were documented in 18 participants, mostly minor AEs. The only SAE was a syncope requiring hospitalization on the day after treatment initiation, leading to discontinuation of the drug. Discussion Baseline VMS frequency was much higher in the German than in the Canadian study and the course of the placebo group had a markedly stronger decrease in VMS-frequency during the PROGEST study (-7.4/d) than in the Canadian trial (-1.4/d). Trial populations differed by age, BMI, the number of women with natural menopause, and comorbidities, mainly hypertension. Conclusion Premature discontinuation of the trial due to insufficient subject accrual rate led to only 55 randomized participants for analysis, therefore the study results lack statistical power. Still, a slight dose-dependent improvement in VMS was seen for all doses, while AE frequency did not increase with progesterone dose.

Purpose: The aim of the study was to describe the preventive option and safety of laparoscopic transabdominal emergency cerclage in pregnant women with advanced cervical shortening after failed vaginal cerclage or in whom vaginal cerclage is no longer possible.

Method: Laparoscopic isthmo-cervical emergency cerclage was carried out in two patients at 13+0 and 15+5 weeks of gestation (GW) respectively. Both patients had cervical shortening and it was no longer possible to expose the cervix after conization or re-conization. The attempts to carry out transvaginal cerclage were unsuccessful. The technical aspects, feasibility, safety, and pregnancy outcomes after laparoscopic transabdominal cerclage are presented here, based on two case reports.

Results: The cerclages were placed after blunt dissection of the uterine vessels and careful introduction of a KELLY forceps through the avascular space between the ascending and descending branches of the uterine vessels without using a needle. The operating times were 93 and 134 minutes (min), respectively. The estimated blood loss during the procedure was less than 50 ml and neither perioperative nor postoperative complications occurred. The subsequent course of both pregnancies was uneventful and fetal development in both cases was normal. In the first case, the baby was delivered by secondary cesarean section following premature rupture of membranes in week 35+4 of gestation. The baby had a birthweight of 2786 g, APGAR scores of 8/9/10 and an umbilical cord arterial pH of 7.36. In the second case, delivery was by primary cesarean section in week 39+5 of gestation. The infant had a birth weight of 4160 g, APGAR scores of 5/9/10 and an umbilical cord arterial pH of 7.20.

Conclusion: Laparoscopic transabdominal cerclage is a safe and effective treatment option, even early in the second trimester of pregnancy, for patients in whom transvaginal cerclage is no longer possible due to anatomical factors. The method is technically very feasible and is associated with positive obstetric outcomes. The overall risk of perioperative complications is within acceptable limits.

Introduction Endometrial cancer is the most common malignant tumor of the female genital organs. In Germany, treatment is provided in both cancer centers certified by the German Cancer Society (Deutsche Krebsgesellschaft, DKG) and in non-certified hospitals. This study investigated whether treatment in DKG-certified centers leads to improved overall survival of patients with endometrial cancer. Materials and Methods Data from 11 legally independent German statutory health insurance (SHI) funds of the AOK were analyzed as well as data from four clinical cancer registries (CCR), resulting in inclusion of 30 102 AOK patients and 8190 registry patients with a diagnosis (incidental cases) of ICD-10-GM code C54 (malignant neoplasm of corpus uteri). For comparative survival analyses, multivariable Cox regressions and Kaplan-Meier analyses were used. Results The Kaplan-Meier estimator for 5-year overall survival was 66.7% for patients from certified centers and 65.0% for patients from non-certified hospitals (using SHI data; CCR data: 63.4% vs. 60.7%). Cox regression adjusted for relevant confounders showed a hazard ratio (HR) of 0.93 (SHI data; 95% CI 0.86 - 1.00; p = 0.050) and 0.935 (CCR data; 95% CI 0.827 - 1.057; p = 0.281) for all-cause mortality. In a subgroup analysis (CCR), patients with International Union against Cancer Control (UICC) stage I had a significant survival benefit if treated in a certified center (HR 0.783; 95% CI 0.620 - 0.987; p = 0.038). Conclusion The study presented herein shows that patients with endometrial cancer treated in a certified cancer center tend to have better survival rates. This should be considered when selecting the treating hospital.

Pregnancy is a unique physiological state in which the maternal body undergoes a series of changes in the metabolism of glucose, lipids, amino acids, and other nutrients in order to adapt to the altered state of pregnancy and provide adequate nutrients for the fetus' growth and development. The metabolism of various nutrients is regulated by one another in order to maintain homeostasis in the body. Failure to adapt to the altered physiological conditions of pregnancy can lead to a range of pregnancy issues, including fetal growth limitation and preeclampsia. A failure of metabolic adaptation during pregnancy is linked to the emergence of preeclampsia. The treatment of preeclampsia by focusing on metabolic changes may provide new therapeutic alternatives.

Introduction: Identifying non-invasive biomarkers which can predict the outcome of intracytoplasmic sperm injection (ICSI) is crucial, particularly in Germany where the challenges are intensified by the Embryo Protection Act. Recent research has highlighted biomarkers within the epidermal growth factor (EGF) family as central to follicular processes, although their predictive utility remains a subject of debate in the literature. Therefore, the primary objective of this study was to investigate the significance of amphiregulin concentrations in follicular fluid and gene expression in mural granulosa cells on oocyte maturation, fertilization, and embryo quality.

Patients and methods: A total of 33 women were recruited at the University Clinic of Saarland Fertility Center (Homburg, Germany). Follicular fluid aspiration consisted of single/individual aspiration of follicles, enabling a 1 : 1 correlation with retrieved oocytes. Follicular fluid and mural granulosa cell samples from 108 oocytes were analyzed. Amphiregulin levels were determined with enzyme-linked immunosorbent assay, while gene expression was analyzed with the StepOnePlus Real-Time PCR System using TaqMan Fast Advanced Master Mix assays.

Results: Results showed that amphiregulin concentrations affect oocyte maturation, fertilization, and embryo quality, while luteinizing hormone concentrations influence oocyte maturation, with significant differences identified between fertilized/unfertilized and good/poor embryo groups. Amphiregulin expression significantly impacts oocyte maturation, with downregulation observed in immature oocytes, while luteinizing hormone/chorionic gonadotropin receptor expression showed no significant differences between groups and did not influence maturation, fertilization, or embryo quality.

Conclusion: These findings are very important for advancing infertility treatment, especially in Germany. The results for amphiregulin may provide prognostic insights which could be useful when selecting viable oocytes and embryos. This research underscores the importance of non-invasive biomarkers for optimizing ICSI outcomes and potentially enhancing the success rates of assisted reproductive technology.

Introduction: Induction of labor is indicated when benefits of delivery outweigh benefits of prolonged pregnancy, which is not always welcomed by women. Castor oil is accepted as an "old household remedy" for labor induction but is not yet part of the official guidelines. Nevertheless, it is often used, mostly even before the women are admitted to the hospital. Data on its actual benefits and safety are missing. Upon accepting the real-world practice of applying castor oil cocktail for labor induction we added castor oil as one option of labor induction in our clinical routine for multiparous women at term, with a history of at least one vaginal delivery. Here we aimed to generate data on the effectivity and safety of castor oil in labor induction by analyzing the real-world data generated in our cohort.

Methods: In our retrospective analysis we included data of a cohort of 148 multiparous women induced by castor oil cocktail and of 286 matched controls receiving established methods according to the current guidelines for labor induction. The castor oil cocktail was prepared following a standardized recipe with quality-tested castor oil. Statistical analysis was performed with SPSS 27.0.

Results: Perinatal outcome data including the rate of vaginal deliveries did not differ between groups, except significantly more neonates were admitted to the neonatal intensive care unit in the group receiving established methods for induction of labor (p = 0.01). In 39 women (26%), administration of castor oil cocktail alone failed to induce labor. The time from initiation of labor induction until delivery was significantly shorter in the castor oil cocktail group (p = 0.04).

Conclusion: Our study demonstrates the safety and effectivity of a castor oil cocktail induction in multiparous women at term in a hospital-based setting using quality-controlled castor oil in a standardized recipe.

Endometriosis patients face a significant economic burden. In addition to the directly attributable costs of the diagnosis and therapy of endometriosis, such as drug treatment and multimodal pain therapy, various indirect follow-up costs can be expected, e.g., due to incapacity for work and reduced work performance. As already reported in previous publications, endometriosis is associated with considerable costs for the health care system and society as well as for the affected women and their families. In order to measure the extent of the costs associated with endometriosis patients, 250 patients with an average age of 32.80 years were recruited via social media and interviewed about their self-financed costs as part of an online survey. The assessed direct costs comprise inpatient treatments, outpatient or pain therapy, fertility treatments, hormone therapies, prescribed and privately paid medications and aids, other therapeutic procedures, and directly attributable travel costs for endometriosis treatments. This resulted in an average cost of € 2059.55 per year. Indirect costs were calculated based on loss of income, day-to-day support, care costs, costs due to follow-up illnesses and other costs. On average, the indirect costs were € 2174.25. The average costs resulting from the survey totalled € 4233.81 per year with a standard deviation of € 8240.31. An increase of out-of-pocket costs can be assumed. This may result from an improved range of services for alternative treatment methods and an increased awareness of the need for personal investment in health. However, further health economic studies are needed to validate the results.

Background: Standardized treatment pathways should make it easier for medical staff and patients to achieve the best possible individual treatment outcome by making sure all relevant information are taken into consideration. The aim of this paper is to identify gaps in care along the treatment pathway through semi-structured patient interviews. Subsequently, it will be discussed if mobile health applications can close these identified gaps in care.

Material and methods: Nine semi-structured interviews of patients with invasive lobular breast cancer were conducted in March 2023 in German at the breast cancer center at Charité Universitätsmedizin Berlin, which were subsequently transcribed word for word and processed using a thematic analysis approach.

Results: Eight recurring themes are identified in the patient interviews: 1. Limited capacity to absorb information, 2. Discrepancy between information needs and information provision, 3. Need for individual initiative, 4. Uncertainty, 5. not being seen and heard, 6. Patient's desires and suggestions for improvement, 7. Use of mobile health apps, 8. Support through an app for patients.

Conclusions: The identified gaps in care of breast cancer patients can be largely addressed through the use of digital health solutions after the establishment of regulatory frameworks, thus improving care for patients with early breast cancer.

Trial registration: The interviews were done within a registry for which ethical approval was obtained by the Ethics Committee of Charité Universitätsmedizin Berlin EA4/180/17.