Value of Cerebroplacental Ratio in Predicting Adverse Perinatal Outcome in Term Pregnancies Complicated by Obesity
To evaluate the performance of cerebroplacental ratio (CPR) in predicting composite adverse perinatal outcome (CAPO) in women with obesity compared to non-obese women at term.
Pregnancy Metabolic Adaptation and Changes in Placental Metabolism in Preeclampsia
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.
Induction of Labor Using Castor Oil Cocktail - an Analysis of Real-world Data
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.
Retrospective Evaluation of C-reactive Protein for Ruling Out Infection After Cesarean Section
Infection after cesarean section is a major contributor to maternal morbidity. Measurement of C-reactive protein (CRP) is a laboratory test frequently conducted to rule out or confirm postoperative infection. The present study aimed to evaluate whether CRP is a suitable tool for ruling out infection after cesarean section and whether there are any reliable cut-off values.
Sleep Disorders in Women: What Should a Gynecologist Know?
Women often face sleep disturbances during key life stages such as adolescence, pregnancy, postpartum period, and perimenopause, influenced by hormonal fluctuations and conditions like polycystic ovary syndrome (PCOS) and premenstrual syndrome (PMS). The goal is to explore women's sleep disorders as classified in the International Classification of Sleep Disorders-3 (ICSD-3). Through a literature review, this study assesses the management of sleep disorders in women, particularly focusing on the link between gynecological disease and sleep disorders. It scrutinizes landmark research in diagnosing and treating women's sleep disorders. Observations indicate that physiological changes during adolescence, pregnancy, postpartum, and perimenopause can cause sleep issues, commonly addressed by gynecologists. Conditions like PCOS and PMS are notably linked to increased sleep disorder occurrences. The conclusion underscores the importance of gynecologists' awareness of the heightened risk of sleep disturbances in women, who often present these issues during consultations.
Endometrial Cancer - Long-Term Survival in Certified Cancer Centers and Non-Certified Hospitals: Comparative Analysis Based on a Large German Retrospective Cohort Study (WiZen)
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. 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. 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). 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.
Firsttrimester Diagnosis and Therapy @ 11 - 13 Weeks of Gestation - Part 2 : Guideline of the DEGUM, ÖGUM, SGUMGG, DGGG, ÖGG, Gynecologie Suisse, DGPM, DGPGM, BVF, ACHSE (AWMF S2e LL 085-002 1.1.2024) (https://register.awmf.org/de/leitlinien/detail/085-002)
This extensive AWMF 085-002 S2e-guideline "First Trimester Diagnosis and Therapy @ 11 - 13 Weeks of Gestation" has systematically analyzed high-quality studies and publications and the existing evidence (evidence tables) and produced recommendations (level of recommendation, level of evidence, strength of consensus). This guideline deals with the following topics in the context of the 11 - 13 weeks scan: the legal basis, screening for anatomical malformations, screening for chromosomal defects, quality assessment and audit, screening for preeclampsia and FGR, screening for preterm birth, screening for abnormally invasive placenta (AIP) and placenta accreta spectrum (PAS), screening for velamentous cord insertion and vasa praevia, screening for diabetes mellitus and LGA. Screening for complications of pregnancy can best be carried out @ 11 - 13 weeks of gestation. The issues of how to identify malformations, chromosomal abnormalities and certain disorders of placentation (high blood pressure and proteinuria, intrauterine growth retardation) have been solved. The problem of how to identify placenta percreta and vasa previa has been partially solved. What is still unsolved is how to identify disorders of glucose metabolism and preterm birth. In the first trimester, solutions to some of these problems are available: parents can be given extensive counselling and the risk that a pregnancy complication will manifest at a later stage can be delayed and reduced. This means that screening is critically important as it helps in decision-making about the best way to manage pregnancy complications (prevention and intervals between follow-up examinations). If no treatment is available and if a termination of pregnancy is considered, the intervention can be carried out with far lower complications compared to the second trimester of pregnancy. In most cases, further examinations are not required and the parents can be reassured. A repeat examination at around week 20 of gestation to complete the screening for malformations is recommended. The guideline will be published simultaneously in the official journals of both professional societies (i.e. Ultraschall in der Medizin/European Journal of Ultrasound for the DEGUM and Geburtshilfe und Frauenheilkunde for the DGGG).
Laparoscopic Transabdominal Needle-free Emergency Cerclage in the Early Second Trimester of Pregnancy after Failed Transvaginal Cerclage: Two Case Reports and a Review of the Literature
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.
Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) - a Prospective Multi-Center Randomized Double-Blind Placebo-Controlled Trial (RDPCT)
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. 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. 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. 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. 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.
Firsttrimester Diagnosis and Therapy @ 11 - 13 Weeks of Gestation - Part 1 : Guideline of the DEGUM, ÖGUM, SGUMGG, DGGG, ÖGG, Gynecologie Suisse, DGPM, DGPGM, BVF, ACHSE (AWMF S2e LL 085-002 1.1.2024) (https://register.awmf.org/de/leitlinien/detail/085-002)
This extensive AWMF 085-002 S2e-guideline "First Trimester Diagnosis and Therapy @ 11 - 13 of Gestation" has systematically analyzed high-quality studies and publications and the existing evidence (evidence tables) and produced recommendations (level of recommendation, level of evidence, strength of consensus). This guideline deals with the following topics in the context of the 11 - 13 weeks scan: the legal basis, screening for anatomical malformations, screening for chromosomal defects, quality assessment and audit, screening for preeclampsia and FGR, screening for preterm birth, screening for abnormally invasive placenta (AIP) and placenta accreta spectrum (PAS), screening for velamentous cord insertion and vasa praevia, screening for diabetes mellitus and LGA. Screening for complications of pregnancy can best be carried out @ 11 - 13 weeks of gestation. The issues of how to identify malformations, chromosomal abnormalities and certain disorders of placentation (high blood pressure and proteinuria, intrauterine growth retardation) have been solved. The problem of how to identify placenta percreta and vasa previa has been partially solved. What is still unsolved is how to identify disorders of glucose metabolism and preterm birth. In the first trimester, solutions to some of these problems are available: parents can be given extensive counselling and the risk that a pregnancy complication will manifest at a later stage can be delayed and reduced. This means that screening is critically important as it helps in decision-making about the best way to manage pregnancy complications (prevention and intervals between follow-up examinations). If no treatment is available and if a termination of pregnancy is considered, the intervention can be carried out with far lower complications compared to the second trimester of pregnancy. In most cases, further examinations are not required and the parents can be reassured. A repeat examination at around week 20 of gestation to complete the screening for malformations is recommended. The guideline will be published simultaneously in the official journals of both professional societies (i.e. Ultraschall in der Medizin/European Journal of Ultrasound for the DEGUM and Geburtshilfe und Frauenheilkunde for the DGGG).
Progressive Muscle Relaxation Training During Pregnancy: Effects on Mental State, Delivery and Labour Pain - a Prospective Study
Progressive muscle relaxation is a widely used technique for relaxation, but studies are rare about efficacy on pregnancy and perinatal outcomes. Aim of our study was to determine whether progressive muscle relaxation affects anxiety and depression levels of pregnant women, pregnancy outcomes, labour pain and analgesic requirements.
Structural Requirements for the Outpatient Treatment of Benign Diseases of the Uterus
In many cases, outpatient surgical treatment of benign diseases of the uterus has advantages over inpatient care. This has been demonstrated by the healthcare situation in other countries. However, the prerequisite for the provision of outpatient services is that this does not lead to any impairment in the quality of care or of patient safety. The ultimate goal should not be to reduce costs but rather to maintain and, ideally, improve the quality of care. This requires that services are not just defined by the surgical procedure but also by the entire treatment chain, including, for example, psychosocial support, and are remunerated accordingly. It is particularly worrying that the final decision as to whether an outpatient operation is possible is not the responsibility of the operating unit, but of the "Medizinischer Dienst," with the corresponding options and threats of sanctions. This situation is unique internationally and requires a paradigm shift. Furthermore, structural prerequisites must be maintained which currently only exist inadequately in Germany. Since a substantial proportion of planned outpatient operations require immediate or secondary inpatient treatment, there must be a barrier-free transition between the outpatient and inpatient sectors. This will require the creation of networks between outpatient service providers and one or more hospitals that are equipped and competent to manage even complex complications. It is important to create structures that, with intensive involvement of the operating unit, include adequate preoperative evaluation and patient education as well as needs-oriented postoperative care at home. The current separation of sectors is a significant hinderance. Moreover, when expanding and promoting outpatient surgery, the aspect of training and further education of specialist staff must be taken into account, as well as cross-sectoral quality assurance. Based on a review of the international literature, this article presents 13 recommendations for adequate structures when providing outpatient services which should serve as a prerequisite for the greatest possible guarantee of patient safety.
From Gaps to Solutions: Semi-Structured Interviews to Identify Care Gaps in Breast Cancer Care and How to Solve Them with Digital Solutions
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.
Prognostic Impact of Surgical Margin Status on Overall Survival of Patients with Early Breast Cancer: A Retrospective Analysis from the Department for Women's Medicine at Charité - University Hospital Berlin
The impact of surgical margins on the prognosis of early breast cancer remains uncertain, particularly in the context of modern treatment approaches. This study aimed to investigate whether involved margins after surgery for early breast cancer affect overall survival.
Novel Antibody-Drug-Conjugates in Routine Clinical Practice for the Treatment of Metastatic Breast Cancer: Adherence, Efficacy and Tolerability - Real-World Data from German Breast Centers
The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.
The Impact of Upper Abdominal Surgery Regarding the Outcome of Patients with Advanced Ovarian Cancer
Residual tumor after cytoreductive surgery is the most important prognostic parameter for the outcome of patients with advanced ovarian cancer (5-year survival rate FIGO III 39%, FIGO IV 20%). As more than half of the patients suffer from upper abdominal tumor burden, surgery in this area is inevitable in order to achieve adequate cytoreduction. Our analysis focuses on the impact of upper abdominal interventions (UAI) regarding residual tumor and prognosis (OS, PFS).
Letter to the Editor: Administration of Antenatal Corticosteroids: Optimal Timing
Reply to: Letter to the Editor: Administration of Antenatal Corticosteroids: Optimal Timing
Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer
Endocrine-based combination therapy with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6 inhibitors) is currently the first-line therapy of choice for patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer (mBC). The efficacy and safety of the treatment with palbociclib, the first CDK4/6 inhibitor approved for this indication, have been confirmed in large randomized controlled clinical trials (RCTs) with strictly defined patient cohorts. Since then, many relevant questions about CDK4/6 inhibition with palbociclib for mBC have been investigated in RCTs and real-world studies. Based on this evidence, palbociclib is widely used in clinical practice since many years because of its efficacy and good tolerability. The aim of this review is to summarize findings from RCTs and RWE considering clinically relevant aspects such as safety, tolerability, quality of life and efficacy with a focus on specific questions and patient characteristics. A critical discussion and review of the overall evidence for endocrine-based therapy with the CDK4/6 inhibitor palbociclib can contribute to support therapy decisions in daily clinical practice.