Pub Date : 2024-11-07eCollection Date: 2024-11-01DOI: 10.1055/a-2413-5449
Sabine Enengl, Peter Oppelt, Richard Bernhard Mayer, Elisabeth Brandlmayr, Philip Sebastian Trautner
Introduction: 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.
Materials and methods: 2056 patients with cesarean section (CS) over a 3-year period were included in a retrospective analysis. Outcome parameters and risk factors for postoperative infection were collected. CRP values from preoperative and postoperative tests were compared. Cut-offs for ruling out infection were assessed.
Results: Among 2056 CSs, postoperative infection occurred in 78 cases (3.8%). The prevalence of infection in emergency CS was lowest, at four out of 134 (2.9%), and the highest prevalence was seen in secondary CS, at 42 of 903 (4.6%; p = 0.35). CRP values in the infection group were significantly higher (preoperative, 1.01 mg/dl vs. 0.62 mg/dl; day 1 postoperative, 7.91 mg/dl vs. 6.44 mg/dl; day 4 postoperative, 8.44 mg/dl vs. 4.09 mg/dl; p = 0.01). A suitable cut-off value for ruling out infection was not identified.
Conclusions: Although CRP values were significantly higher in the infection group, the clinical relevance of this appears to be negligible. CRP testing does not appear to be a reliable tool for diagnosing or ruling out postoperative infection.
{"title":"Retrospective Evaluation of C-reactive Protein for Ruling Out Infection After Cesarean Section.","authors":"Sabine Enengl, Peter Oppelt, Richard Bernhard Mayer, Elisabeth Brandlmayr, Philip Sebastian Trautner","doi":"10.1055/a-2413-5449","DOIUrl":"https://doi.org/10.1055/a-2413-5449","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Materials and methods: </strong>2056 patients with cesarean section (CS) over a 3-year period were included in a retrospective analysis. Outcome parameters and risk factors for postoperative infection were collected. CRP values from preoperative and postoperative tests were compared. Cut-offs for ruling out infection were assessed.</p><p><strong>Results: </strong>Among 2056 CSs, postoperative infection occurred in 78 cases (3.8%). The prevalence of infection in emergency CS was lowest, at four out of 134 (2.9%), and the highest prevalence was seen in secondary CS, at 42 of 903 (4.6%; p = 0.35). CRP values in the infection group were significantly higher (preoperative, 1.01 mg/dl vs. 0.62 mg/dl; day 1 postoperative, 7.91 mg/dl vs. 6.44 mg/dl; day 4 postoperative, 8.44 mg/dl vs. 4.09 mg/dl; p = 0.01). A suitable cut-off value for ruling out infection was not identified.</p><p><strong>Conclusions: </strong>Although CRP values were significantly higher in the infection group, the clinical relevance of this appears to be negligible. CRP testing does not appear to be a reliable tool for diagnosing or ruling out postoperative infection.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 11","pages":"1066-1073"},"PeriodicalIF":2.4,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11543105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Constantin von Kaisenberg, Peter Kozlowski, Karl-Oliver Kagan, Markus Hoopmann, Kai-Sven Heling, Rabih Chaoui, Philipp Klaritsch, Barbara Pertl, Tilo Burkhardt, Sevgi Tercanli, Jochen Frenzel, Christine Mundlos
This extensive AWMF 085-002 S2e-guideline "First Trimester Diagnosis and Therapy @ 11 - 13 +6 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 +6 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 +6 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. Note: 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).
这份内容广泛的 AWMF 085-002 S2e-指南 "妊娠 11-13+6 周的第一孕期诊断与治疗 "对高质量的研究和出版物以及现有证据(证据表)进行了系统分析,并提出了建议(建议级别、证据级别、共识强度)。本指南涉及 11-13+6 周扫描的以下主题:法律依据、解剖畸形筛查、染色体缺陷筛查、质量评估和审核、子痫前期和胎儿畸形筛查、早产筛查、异常侵入性胎盘(AIP)和胎盘早剥谱系(PAS)筛查、绒毛膜性脐带插入和前庭大血管筛查、糖尿病和 LGA 筛查。妊娠并发症筛查最好在妊娠 11-13+6 周进行。如何识别畸形、染色体异常和某些胎盘疾病(高血压和蛋白尿、宫内发育迟缓)的问题已经解决。如何识别前置胎盘和前置血管的问题也已部分解决。目前仍未解决的问题是如何识别糖代谢紊乱和早产。在妊娠的前三个月,这些问题中的一些问题已经有了解决方案:父母可以得到广泛的咨询,妊娠并发症在晚期表现出来的风险可以被推迟和降低。这意味着筛查是至关重要的,因为它有助于决策处理妊娠并发症的最佳方法(预防和随访检查的间隔时间)。如果无法进行治疗,或考虑终止妊娠,则可以在并发症远低于妊娠后三个月的情况下进行干预。在大多数情况下,无需进行进一步检查,父母也可以放心。建议在妊娠 20 周左右再次进行检查,以完成畸形筛查。注:该指南将同时在两个专业协会的官方期刊上发表(即 DEGUM 的 Ultraschall in der Medizin/European Journal of Ultrasound 和 DGG 的 Geburtshilfe und Frauenheilkunde)。
{"title":"Firsttrimester Diagnosis and Therapy @ 11 - 13 <sup>+6</sup> 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).","authors":"Constantin von Kaisenberg, Peter Kozlowski, Karl-Oliver Kagan, Markus Hoopmann, Kai-Sven Heling, Rabih Chaoui, Philipp Klaritsch, Barbara Pertl, Tilo Burkhardt, Sevgi Tercanli, Jochen Frenzel, Christine Mundlos","doi":"10.1055/a-2280-8772","DOIUrl":"https://doi.org/10.1055/a-2280-8772","url":null,"abstract":"<p><p>This extensive AWMF 085-002 S2e-guideline \"First Trimester Diagnosis and Therapy @ 11 - 13 <sup>+6</sup> 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 <sup>+6</sup> 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 <sup>+6</sup> 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. <b>Note:</b> 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).</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"928-941"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Structural Requirements for the Outpatient Treatment of Benign Diseases of the Uterus.","authors":"Cosima Brucker, Thomas Dimpfl, Anton Scharl","doi":"10.1055/a-2376-9748","DOIUrl":"10.1055/a-2376-9748","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"920-927"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Constantin von Kaisenberg, Peter Kozlowski, Karl-Oliver Kagan, Markus Hoopmann, Kai-Sven Heling, Rabih Chaoui, Philipp Klaritsch, Barbara Pertl, Tilo Burkhardt, Sevgi Tercanli, Jochen Frenzel, Christine Mundlos
This extensive AWMF 085-002 S2e-guideline "First Trimester Diagnosis and Therapy @ 11 - 13 +6 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 +6 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 +6 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. Note: 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).
这份内容广泛的 AWMF 085-002 S2e-指南 "妊娠 11-13+6 周的第一孕期诊断与治疗 "对高质量的研究和出版物以及现有证据(证据表)进行了系统分析,并提出了建议(建议级别、证据级别、共识强度)。本指南涉及 11-13+6 周扫描的以下主题:法律依据、解剖畸形筛查、染色体缺陷筛查、质量评估和审核、子痫前期和胎儿畸形筛查、早产筛查、异常侵入性胎盘(AIP)和胎盘早剥谱系(PAS)筛查、绒毛膜性脐带插入和前庭大血管筛查、糖尿病和 LGA 筛查。妊娠并发症筛查最好在妊娠 11-13+6 周进行。如何识别畸形、染色体异常和某些胎盘疾病(高血压和蛋白尿、宫内发育迟缓)的问题已经解决。如何识别前置胎盘和前置血管的问题也已部分解决。目前仍未解决的问题是如何识别糖代谢紊乱和早产。在妊娠的前三个月,这些问题中的一些问题已经有了解决方案:父母可以得到广泛的咨询,妊娠并发症在晚期表现出来的风险可以被推迟和降低。这意味着筛查是至关重要的,因为它有助于决策处理妊娠并发症的最佳方法(预防和随访检查的间隔时间)。如果无法进行治疗,或考虑终止妊娠,则可以在并发症远低于妊娠后三个月的情况下进行干预。在大多数情况下,无需进行进一步检查,父母也可以放心。建议在妊娠 20 周左右再次进行检查,以完成畸形筛查。注:该指南将同时在两个专业协会的官方期刊上发表(即 DEGUM 的 Ultraschall in der Medizin/European Journal of Ultrasound 和 DGG 的 Geburtshilfe und Frauenheilkunde)。
{"title":"Firsttrimester Diagnosis and Therapy @ 11 - 13 <sup>+6</sup> 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).","authors":"Constantin von Kaisenberg, Peter Kozlowski, Karl-Oliver Kagan, Markus Hoopmann, Kai-Sven Heling, Rabih Chaoui, Philipp Klaritsch, Barbara Pertl, Tilo Burkhardt, Sevgi Tercanli, Jochen Frenzel, Christine Mundlos","doi":"10.1055/a-2280-8852","DOIUrl":"https://doi.org/10.1055/a-2280-8852","url":null,"abstract":"<p><p>This extensive AWMF 085-002 S2e-guideline \"First Trimester Diagnosis and Therapy @ 11 - 13 <sup>+6</sup> 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 <sup>+6</sup> 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 <sup>+6</sup> 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. <b>Note:</b> 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).</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"943-960"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sissi Valentina Beinert, Frauke Kleinsorge, Julia Worm, Katharina Victoria Tropschuh, Vanadin Seifert-Klauss
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.
{"title":"Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) - a Prospective Multi-Center Randomized Double-Blind Placebo-Controlled Trial (RDPCT).","authors":"Sissi Valentina Beinert, Frauke Kleinsorge, Julia Worm, Katharina Victoria Tropschuh, Vanadin Seifert-Klauss","doi":"10.1055/a-2322-0967","DOIUrl":"10.1055/a-2322-0967","url":null,"abstract":"<p><p><b>Introduction</b> 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. <b>Methods</b> 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. <b>Results</b> 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. <b>Discussion</b> 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. <b>Conclusion</b> 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.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"969-978"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Judith Hansinger, Vinzenz Völkel, Michael Gerken, Olaf Schoffer, Pauline Wimberger, Veronika Bierbaum, Christoph Bobeth, Martin Rößler, Patrik Dröge, Thomas Ruhnke, Christian Günster, Kees Kleihues-van Tol, Theresa Link, Karin Kast, Thomas Papathemelis, Olaf Ortmann, Jochen Schmitt, Monika Klinkhammer-Schalke
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.
{"title":"Endometrial Cancer - Long-Term Survival in Certified Cancer Centers and Non-Certified Hospitals: Comparative Analysis Based on a Large German Retrospective Cohort Study (WiZen).","authors":"Judith Hansinger, Vinzenz Völkel, Michael Gerken, Olaf Schoffer, Pauline Wimberger, Veronika Bierbaum, Christoph Bobeth, Martin Rößler, Patrik Dröge, Thomas Ruhnke, Christian Günster, Kees Kleihues-van Tol, Theresa Link, Karin Kast, Thomas Papathemelis, Olaf Ortmann, Jochen Schmitt, Monika Klinkhammer-Schalke","doi":"10.1055/a-1869-2060","DOIUrl":"10.1055/a-1869-2060","url":null,"abstract":"<p><p><b>Introduction</b> 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. <b>Materials and Methods</b> 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. <b>Results</b> 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). <b>Conclusion</b> 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.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"979-988"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Davut Dayan, Marinus Schmid, Florian K Ebner, Wolfgang Janni, Frank Reister, Beate Hüner, Krisztian Lato, Ulrike Friebe-Hoffmann, Stefan Lukac
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.
{"title":"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.","authors":"Davut Dayan, Marinus Schmid, Florian K Ebner, Wolfgang Janni, Frank Reister, Beate Hüner, Krisztian Lato, Ulrike Friebe-Hoffmann, Stefan Lukac","doi":"10.1055/a-2373-0639","DOIUrl":"10.1055/a-2373-0639","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"989-998"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Pregnancy Metabolic Adaptation and Changes in Placental Metabolism in Preeclampsia.","authors":"Yaxi Li, Ling Ma, Ruifen He, Fei Teng, Xue Qin, Xiaolei Liang, Jing Wang","doi":"10.1055/a-2403-4855","DOIUrl":"https://doi.org/10.1055/a-2403-4855","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 11","pages":"1033-1042"},"PeriodicalIF":2.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11543110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}