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1.
Ultraschall Med ; 45(2): 190-198, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37168018

RESUMO

BACKGROUND: Cervical pessaries are an established therapy option for patients at risk for spontaneous preterm birth (sPTB). The uterocervical angle (UCA) remains a promising sPTB predictor. However, its clinical significance has yet to be described in patients treated with a pessary. METHODS: This study analyzed data of patients treated with a pessary because of cervical shortening in singleton pregnancies. The patients were divided into 2 groups according to transvaginal ultrasound findings: the funneling group (n = 68) and the no-funneling group (n = 42). Moreover, we analyzed patients within these prespecified groups according to the UCA < 95° and ≥ 95°. RESULTS: Delivery occurred significantly earlier in patients treated with a pessary and with a high UCA ≥ 95°(p = 0.006). The median gestational age at delivery in patients treated with a pessary and with no funneling and a UCA < 95° vs. ≥ 95° were 39.00 and 36.14 weeks, respectively (p = 0.005). In cases with funneling and a UCA < 95° vs. ≥ 95° the mean gestational age at delivery was 38.14 and 38.07 weeks respectively (p=1,00). There was a significant negative linear correlation between UCA and the gestational age at delivery in all patients (p = 0.04), which was even profound in the group without funneling (p = 0.0002). However, we found no significant correlation between cervical length and gestational age at delivery in all patients (p = 0.42) as well as in the group without funneling (p = 0.28). CONCLUSION: In spite of pessary treatment, patients with UCA ≥ 95° presented with a higher risk of sPTB compared to patients with UCA < 95°. This suggests that the UCA seems to be a better predictor of sPTB than the cervical length in patients receiving pessary treatment.


Assuntos
Nascimento Prematuro , Gravidez , Feminino , Recém-Nascido , Humanos , Pessários , Colo do Útero/diagnóstico por imagem , Ultrassonografia
2.
J Perinat Med ; 51(6): 775-781, 2023 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-36972689

RESUMO

OBJECTIVES: To investigate the adherence of German perinatal specialist units and those of basic obstetric care to the national guideline we compared data from a nation-wide survey on the practice of maintenance tocolysis, tocolysis in preterm premature rupture of membranes and in the perioperative setting of cervical cerclage, and bedrest during and after tocolysis with recommendations from the current German Guideline 015/025 "Prevention and Treatment of Preterm Birth". METHODS: A total of 632 obstetric clinics in Germany were approached and received a link to an online questionnaire. Data were descriptively analyzed by performing measures of frequency. To compare two or more groups Fisher's exact test was used. RESULTS: The response rate was 19%; 23 (19.2%) of respondents did not perform maintenance tocolysis, while 97 (80.8%) conducted maintenance tocolysis; 30 (25.0%) of obstetric units performed cervical cerclage without tocolysis and 90 (75.0%) combined cervical cerclage with tocolysis; 11 (9.2%) of respondents did not use tocolytics in patients with preterm premature rupture of membranes, while 109 (90.8%) conducted tocolysis in these patients; 69 (57.5%) of obstetric units did not recommend bed rest during tocolysis, whereas 51 (42.5%) favored bedrest. Perinatal care centers of basic obstetric care recommend bed arrest during tocolysis statistically significant more often to their patients than those of higher perinatal care levels (53.6 vs. 32.8%, p=0.0269). CONCLUSIONS: The results of our survey are in accordance to others from different countries and reveal considerable discrepancies between evidence-based guideline recommendations and daily clinical practice.


Assuntos
Cerclagem Cervical , Ruptura Prematura de Membranas Fetais , Nascimento Prematuro , Tocolíticos , Gravidez , Feminino , Humanos , Recém-Nascido , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle , Cerclagem Cervical/métodos , Tocólise/métodos , Tocolíticos/uso terapêutico , Inquéritos e Questionários , Ruptura Prematura de Membranas Fetais/epidemiologia , Ruptura Prematura de Membranas Fetais/terapia
3.
Artigo em Alemão | MEDLINE | ID: mdl-38065551

RESUMO

Hyperemesis gravidarum (HG) is a multifactorial disease characterized by severe and persisting nausea and vomiting, impairment of oral intake, weight loss of at least 5%, electrolyte abnormalities, and dehydration. The prevalence of HG ranges from 0.3 to 10% worldwide. The diagnosis is made by the patient's prehistory, clinical symptoms, physical examination, and the typical laboratory abnormalities. Therapeutic cornerstones are nutrition advice, consultation of life style, psychological/psychosocial support of the mother as well as the administration of antiemetics in a stepwise approach, depending on the severity of symptoms, and finally admission to hospital in severe cases. Treatment of patients requires close interprofessional and interdisciplinary cooperation.

4.
Matern Child Health J ; 25(4): 656-665, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33211261

RESUMO

OBJECTIVES: Active and passive exposure to tobacco cigarettes during pregnancy is associated with multiple negative health outcomes for the fetus. In addition, exposure to e-cigarettes has been progressively discussed as a new threat to fetal health. Until now, there has been a lack of studies examining active and passive exposure to tobacco and e-cigarettes among pregnant women. The objective of our current STudy on E-cigarettes and Pregnancy (STEP) was to advance and complement the current knowledge regarding active and passive exposure to tobacco and e-cigarettes before pregnancy and during early and late pregnancy. METHODS: One element of the STEP study was a quantitative cross-sectional design: A sample of 540 pregnant women recruited at an obstetrician clinic in Hamburg from April 2018 to January 2019 were surveyed once via a standardized questionnaire and provided complete information regarding their consumption of tobacco and e-cigarettes. We performed a descriptive analysis of tobacco and e-cigarette use before pregnancy and during early and late pregnancy, as well as bivariate analysis of these variables with sociodemographic determinants. Passive exposure was assessed by asking the participating pregnant women about the consumption of tobacco and e-cigarettes by their partners, in general, and in their homes. RESULTS: Before pregnancy, 20.0% of the participants used tobacco cigarettes exclusively, 1.3% used e-cigarettes exclusively, and 6.5% were dual users. Educational level was significantly associated with tobacco cigarette use (p < 0.001) and dual use (p = 0.047) before pregnancy. During early (late) pregnancy, 8.7% (2.8%) used tobacco cigarettes and 0.4% (0.0%) used e-cigarettes exclusively. Twenty-point nine percent of women's partners consumed tobacco cigarettes exclusively, 2.7% consumed e-cigarettes exclusively, and 2.7% consumed both. A total of 8.5% (16.7%) of the partners who consumed tobacco cigarettes exclusively (e-cigarettes exclusively) did so in the women's homes. CONCLUSIONS FOR PRACTICE: Among pregnant women, the use of tobacco cigarettes remains prominent before and during pregnancy, while e-cigarette use predominately occurs before pregnancy. Our study shows that pregnant women are frequently exposed to their partners' tobacco and e-cigarette use within their homes. Strategies to reduce such exposure should be further intensified.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco , Estudos Transversais , Humanos , Gravidez , Fumar , Nicotiana
5.
Gynakologe ; 54(3): 186-194, 2021.
Artigo em Alemão | MEDLINE | ID: mdl-33612852

RESUMO

Around 3% of all pregnancies are complicated by preterm prelabor rupture of membranes (PPROM) before 37 + 0 weeks of gestation. Since PPROM is likely to be associated with microbial invasion of the amniotic cavity (MIAC)-either before or secondary to PPROM-the risk of developing intraamniotic inflammation (IAI) is high. IAI is associated with short latency to delivery and with adverse short- and long-term outcomes for the newborn, especially in cases of fetal inflammatory response syndrome (FIRS). Prediction of IAI based on maternal parameters is difficult or impossible. The recently established definition of triple I ("infection, inflammation, or both") is based on the parameter "maternal body temperature". If this is increased to ≥ 38.0 °C and there is no other reason to explain maternal fever, the finding is suspicious for triple I if at least one other of the following parameters can be found: fetal tachycardia > 160 bpm for at least 10 min, maternal leukocytes > 15,000/µl without administration of corticosteroids, or purulent fluid from the cervical os. Pregnancies suspicious for triple I should be terminated. The confirmation of triple I is only possible by placental histology (histologically confirmed chorioamnionitis, HCA). Confirmation based on amniocentesis (positive Gram stain, low glucose concentration [<14 mg/dl], elevated white blood cell count [>30 cells/mm3], positive culture) takes too long and is unreliable. Serial determinations of C­reactive protein also do not allow reliable diagnosis of IAI. Studies using interleukin 6 measurements from the posterior fornix and/or cervical os are promising methods, the validation of which is awaited.

6.
Gynakologe ; 54(5): 341-356, 2021.
Artigo em Alemão | MEDLINE | ID: mdl-33896963

RESUMO

Intrahepatic cholestasis of pregnancy (ICP) is the most frequent pregnancy-specific liver disease. It is characterized by pruritus and an accompanying elevation of serum bile acid concentrations and/or alanine aminotransferase (ALT), which are the key parameters in the diagnosis. Despite good maternal prognosis, elevated bile acid concentration in maternal blood is an influencing factor to advers fetal outcome. The ICP is associated with increased rates of preterm birth, neonatal unit admission and stillbirth. This is the result of acute fetal asphyxia as opposed to a chronic uteroplacental insufficiency. Reliable monitoring or predictive tools (e.g. cardiotocography (CTG) or ultrasound) that help to prevent advers events are yet to be explored. Medicinal treatment with ursodeoxycholic acid (UDCA) does not demonstrably reduce adverse perinatal outcomes but does improve pruritus and liver function test results. Bile acid concentrations and gestational age should be used as indications to determine delivery. There is a high risk of recurrence in subsequent pregnancies.

8.
Z Geburtshilfe Neonatol ; 223(5): 304-316, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31623006

RESUMO

AIMS: This is an official guideline of the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (ÖGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The aim of this guideline is to improve the prediction, prevention and management of preterm birth based on evidence obtained from recent scientific literature, the experience of the members of the guideline commission and the views of self-help groups. METHODS: Based on the international literature, the members of the participating medical societies and organizations developed Recommendations and Statements. These were adopted following a formal process (structured consensus conference with neutral moderation, voting was done in writing using the Delphi method to achieve consensus). RECOMMENDATIONS: Part I of this short version of the guideline lists Statements and Recommendations on the epidemiology, etiology, prediction and primary and secondary prevention of preterm birth.


Assuntos
Guias de Prática Clínica como Assunto , Nascimento Prematuro , Áustria , Feminino , Humanos , Recém-Nascido , Gravidez , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/etiologia , Nascimento Prematuro/prevenção & controle , Prevenção Primária , Sistema de Registros , Prevenção Secundária , Sociedades Médicas
9.
Z Geburtshilfe Neonatol ; 223(6): 373-394, 2019 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-31801169

RESUMO

AIMS: This is an official guideline of the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (ÖGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The aim of this guideline is to improve the prediction, prevention and management of preterm birth based on evidence obtained from recently published scientific literature, the experience of the members of the guideline commission and the views of self-help groups. METHODS: The members of the participating medical societies and organizations developed Recommendations and Statements based on the international literature. The Recommendations and Statements were adopted following a formal consensus process (structured consensus conference with neutral moderation, voting done in writing using the Delphi method to achieve consensus). RECOMMENDATIONS: Part 2 of this short version of the guideline presents Statements and Recommendations on the tertiary prevention of preterm birth and the management of preterm premature rupture of membranes.


Assuntos
Ruptura Prematura de Membranas Fetais , Trabalho de Parto Prematuro/prevenção & controle , Guias de Prática Clínica como Assunto , Nascimento Prematuro , Sociedades Médicas , Prevenção Terciária , Incompetência do Colo do Útero , Áustria , Feminino , Ruptura Prematura de Membranas Fetais/prevenção & controle , Ruptura Prematura de Membranas Fetais/terapia , Humanos , Recém-Nascido , Obstetrícia , Gravidez , Nascimento Prematuro/prevenção & controle , Nascimento Prematuro/terapia , Sistema de Registros
10.
Transfusion ; 58(1): 88-99, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29023759

RESUMO

BACKGROUND: Transplantation of hematopoietic stem cells (HSCs) from peripheral blood (PB) or cord blood (CB) is well established. HSCs from CB are associated with a lower risk of graft-versus-host disease (GVHD), but antigen-independent expanded CB- and PB-derived T cells can induce GVHD in allo-HSC recipients. CB-derived cells might be more suitable for adoptive immunotherapy as they have unique T-cell characteristics. Here, we describe functional differences between CB and PB T cells stimulated with different cytokine combinations involved in central T-cell activation. STUDY DESIGN AND METHODS: Isolated CD8+ T cells from CB and PB were stimulated antigen independently with anti-CD3/CD28 stimulator beads or in an antigen-dependent manner with artificial antigen-presenting cells loaded with the HLA-A*02:01-restricted peptide of tumor-associated melanoma antigen recognized by T cells 1 (MART1). CB and PB T cells cultured in the presence of interleukin (IL)-7, IL-15, IL-12, and IL-21 were characterized for T-cell phenotype and specificity, that is, by CD107a, interferon-γ, tumor necrosis factor-α, and IL-2 expression. RESULTS: After antigen-independent stimulation, activated CD8+ CB T cells exhibited stronger proliferation and function than those from PB. After antigenic stimulation, MART1-reactive CB T cells were naïve (CD45RA+CCR7+), cytotoxic, and highly variable in expressing homing marker CD62L. Addition of IL-21 resulted in increased T-cell proliferation, whereas supplementation with IL-12 decreased IL-21-induced expansion, but increased the functionality and cytotoxicity of CB and PB T cells. CONCLUSION: MART1-reactive CB T cells with a more naïve phenotype and improved properties for homing can be generated. The results contribute to better understanding the effects on GVHD and graft versus tumor.


Assuntos
Sangue Fetal/citologia , Imunoterapia Adotiva/métodos , Ativação Linfocitária , Especificidade do Receptor de Antígeno de Linfócitos T , Subpopulações de Linfócitos T/imunologia , Linfócitos T Citotóxicos/imunologia , Separação Celular , Células Cultivadas , Feminino , Antígeno HLA-A2/imunologia , Humanos , Imunofenotipagem , Interleucinas/farmacologia , Ativação Linfocitária/efeitos dos fármacos , Proteína 1 de Membrana Associada ao Lisossomo/análise , Antígeno MART-1/imunologia , Microesferas , Especificidade de Órgãos , Subpopulações de Linfócitos T/efeitos dos fármacos , Subpopulações de Linfócitos T/metabolismo , Linfócitos T Citotóxicos/metabolismo
11.
Arch Gynecol Obstet ; 298(3): 521-527, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29938346

RESUMO

PURPOSE: ß2-sympathomimetics are used in obstetrics as tocolytic agents, despite a remarkable profile of side effects. Recently, the ß2-sympathomimetic tocolytic drug hexoprenaline was identified as an independent risk factor for the development of infantile hemangioma (IH) in preterm infants. The aim of this study was to evaluate whether this observed effect was applicable to other ß2-mimetic tocolytic agents like fenoterol. METHODS: Clinical prospectively collected data of all infants born between 2001 and 2012 and admitted to the neonatal intensive care unit (NICU) at Heidelberg University Hospital and respective maternal data were merged. For the current retrospective cohort study, cases (IH) were matched to controls (no IH) at a ratio of 1:4, adjusting for birth weight, gestational age, gender and multiple gestations. Prenatal exposure to fenoterol and perinatal outcome were analyzed in the total cohort and in subgroups. RESULTS: N = 5070 infants were admitted to our neonatal department, out of which n = 172 infants with IH were identified and compared to n = 596 matched controls. Exposure to fenoterol was not associated with a higher rate of IH in the total matched population (OR 0.926, 95% CI 0.619-1.384) or in a subgroup of neonates < 32 weeks of gestation or with a birth weight < 1500 g (OR 1.127, 95% CI 0.709-1.791). In the total matched population, prenatal exposure to glucocorticoids was associated with a reduced occurrence of IH (OR 0.566, 95% CI 0.332-0.964) and neonates with IH showed a prolonged total hospital stay compared to controls (69 vs. 57 days, p = 0.0033). Known risk factors for IH were confirmed by our large study cohort and included female gender, low birth weight, preterm birth and multiple gestations (all p < 0.005). CONCLUSIONS: Exposure to fenoterol during pregnancy does not increase the occurrence of IH. Further studies are needed to explore differences in the risk profiles of different ß2-sympathomimetic tocolytic drugs.


Assuntos
Fenoterol/uso terapêutico , Hemangioma/epidemiologia , Simpatomiméticos/uso terapêutico , Tocolíticos/uso terapêutico , Peso ao Nascer , Estudos de Coortes , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal , Masculino , Gravidez , Estudos Retrospectivos , Tocólise
12.
Mol Ther ; 24(7): 1216-26, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27138041

RESUMO

Retroviral engineering of hematopoietic stem cell-derived precursor T-cells (preTs) opens the possibility of targeted T-cell transfer across human leukocyte antigen (HLA)-barriers. Alpharetroviral vectors exhibit a more neutral integration pattern thereby reducing the risk of insertional mutagenesis. Cord blood-derived CD34+ cells were transduced and differentiated into preTs in vitro. Two promoters, elongation-factor-1-short-form, and a myeloproliferative sarcoma virus variant in combination with two commonly used envelopes were comparatively assessed choosing enhanced green fluorescent protein or a third-generation chimeric antigen receptor (CAR) against CD123 as gene of interest. Furthermore, the inducible suicide gene iCaspase 9 has been validated. Combining the sarcoma virus-derived promoter with a modified feline endogenous retrovirus envelope glycoprotein yielded in superior transgene expression and transduction rates. Fresh and previously frozen CD34+ cells showed similar transduction and expansion rates. Transgene-positive cells did neither show proliferative impairment nor alteration in their lymphoid differentiation profile. The sarcoma virus-derived promoter only could express sufficient levels of iCaspase 9 to mediate dimerizer-induced apoptosis. Finally, the CD123 CAR was efficiently expressed in CD34+ cells and proved to be functional when expressed on differentiated T-cells. Therefore, the transduction of CD34+ cells with alpharetroviral vectors represents a feasible and potentially safer approach for stem cell-based immunotherapies for cancer.


Assuntos
Alpharetrovirus/genética , Sangue Fetal/citologia , Engenharia Genética , Vetores Genéticos/genética , Células Precursoras de Linfócitos T/citologia , Células Precursoras de Linfócitos T/metabolismo , Antígenos CD34/metabolismo , Apoptose , Proteínas da Membrana Bacteriana Externa , Biomarcadores , Diferenciação Celular , Expressão Gênica , Técnicas de Transferência de Genes , Genes Reporter , Células-Tronco Hematopoéticas/citologia , Células-Tronco Hematopoéticas/metabolismo , Humanos , Subunidade alfa de Receptor de Interleucina-3/imunologia , Fenótipo , Regiões Promotoras Genéticas , Receptores de Antígenos de Linfócitos T/genética , Receptores de Antígenos de Linfócitos T/imunologia , Linfócitos T/citologia , Linfócitos T/imunologia , Linfócitos T/metabolismo , Transdução Genética , Transgenes
13.
Artigo em Alemão | MEDLINE | ID: mdl-27631446

RESUMO

Worldwide, post-partum haemorrhage (PHH) remains one of the leading causes for maternal mortality. The German Society of Gynaecology and Obstetrics, the German Midwifes' Society, the German Society of Thrombosis and Haemostasis and the German Society of Anaesthesiology and Intensive Care updated the former guideline. The resulting recommendations are the results of a structured literature search and a formal consensus process and contain all aspects of PPH including diagnosis, causes, risk factors and therapy. Key aspect of the anaesthesiological and haemostatic therapies is the development of an interdisciplinary standard operating procedure containing medical options related to the bleeding's cause and severity as well as the surgical option. For suspected PPH, this guideline emphasizes clinical and laboratory-based diagnostics, as only those will enable an early identification of the bleeding's causes and the resulting causative therapy. Recommendations cover evidence-based application of uterotonics for atony as well as tranexamic acid, calcium, factor concentrates and blood products. Additionally, recommendations are given on the topics of cell salvage, controlled hypotension and restrictive transfusion triggers.


Assuntos
Transfusão de Sangue/normas , Técnicas de Laboratório Clínico/normas , Técnicas Hemostáticas/normas , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , Guias de Prática Clínica como Assunto , Medicina Baseada em Evidências , Alemanha , Ginecologia/normas , Obstetrícia/normas , Resultado do Tratamento
14.
Geburtshilfe Frauenheilkd ; 84(1): 48-58, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38205043

RESUMO

The effectiveness of antenatal corticosteroids (ACS) in significantly reducing respiratory distress syndrome (RDS) depends crucially on the timing. It is successful if delivery takes place between 24 hours and seven days following administration; after this period, the side effects seem to predominate. In addition, an increased rate of mental impairment and behavioral disorders are observed in children born full-term after ACS administration. The optimal timing of ACS administration depends crucially on the given indication; to date, it has been achieved in only 25-40% of cases. ACS administration is always indicated in PPROM, in severe early pre-eclampsia, in fetal IUGR with zero or reverse flow in the umbilical artery, in placenta previa with bleeding, and in patients experiencing premature labor with a cervical length < 15 mm. The risk of women with asymptomatic cervical insufficiency giving birth within seven days is very low. In this case, ACS should not be administered even if the patient's cervical length is less than 15 mm, provided that the cervix is closed and there are no other risk factors for a premature birth. The development of further diagnostic methods with improved power to predict premature birth is urgently needed in order to optimize the timing of ACS administration in this patient population. Caution when administering ACS is also indicated in women experiencing premature labor who have a cervical length ≥ 15 mm. Further studies using amniocentesis are needed in order to identify the patient population with microbial invasion of the amniotic cavity/intra-amniotic infection (MIAC/IAI), and to define threshold values at which delivery is indicated. ACS administration is not performed as an emergency measure, usually not even before transfer to a perinatal center. Therefore, whenever possible, the indication for ACS administration should be determined by a clinician who is highly experienced in perinatology.

15.
Geburtshilfe Frauenheilkd ; 84(1): 43-47, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38178898

RESUMO

Preterm premature rupture of membranes (PPROM) is one of the leading causes of perinatal morbidity and mortality. After a PPROM, more than 50% of pregnant women are delivered within 7 days. Fetal and maternal risks are primarily due to infection and inflammation, placental abruption, umbilical cord complications and preterm birth. Standard care usually consists of an expectant approach. Management includes the administration of antenatal steroids and antibiotic therapy. Patients with PPROM require close monitoring. The management of pregnant women with PPROM (inpatient vs. outpatient) is still the subject of controversial debate. The international guidelines also do not offer a clear stance. The statement presented here discusses the current state of knowledge.

16.
Int J Gynaecol Obstet ; 165(2): 607-620, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-37830250

RESUMO

BACKGROUND: Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. OBJECTIVES: Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure. SEARCH STRATEGY AND SELECTION CRITERIA: Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries. DATA COLLECTION AND ANALYSIS: We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices. MAIN RESULTS: Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I2 = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls. CONCLUSION: Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.


Assuntos
Nascimento Prematuro , Gravidez , Recém-Nascido , Feminino , Humanos , Nascimento Prematuro/prevenção & controle , Pessários , Legislação de Dispositivos Médicos , Ensaios Clínicos Controlados Aleatórios como Assunto , Colo do Útero , Gravidez de Gêmeos
17.
Am J Obstet Gynecol ; 209(3): 225.e1-5, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23727525

RESUMO

OBJECTIVE: To describe the use of gauze covered with chitosan, a potent hemostatic agent derived from chitin, in the treatment of postpartum hemorrhage (PPH). STUDY DESIGN: Patients suffering from postpartum hemorrhage were treated by uterine packing with chitosan-covered gauze, either through the hysterotomy in case of cesarean delivery or transvaginally, for up to 24 hours. RESULTS: Chitosan-covered gauze was used in 19 cases of postpartum hemorrhage due to uterine atony, placenta accreta/increta, or anticoagulation, including 5 severe cases where a hysterectomy seemed inevitable otherwise. In all but one case, the bleeding stopped and further interventions were avoided. Over comparable periods of time (18 months) and births (3822 vs 4077) before and after the introduction of the chitosan gauze in our clinic, the rate of peripartum hysterectomies was reduced by 75% (8 vs 2; odds ratio, 4.27; P = .044). CONCLUSION: Chitosan-covered gauze is a viable option in the treatment of (severe) postpartum hemorrhage. It is easy to use and requires no special training. It can be used after both vaginal and cesarean deliveries, and there are no adverse side effects. Furthermore, it is very inexpensive compared with other treatment options, making it suitable for use also in low resource-countries, where the death toll due to postpartum hemorrhage is especially high.


Assuntos
Bandagens , Quitosana/administração & dosagem , Hemorragia Pós-Parto/terapia , Adulto , Feminino , Humanos , Gravidez
18.
PLoS One ; 18(4): e0283944, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37023066

RESUMO

BACKGROUND: The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a preterm birth remains elusive. The aim of this study is to investigate the hypothesis whether the application of a cervical pessary may stabilize the ectocervical stiffness in order to achieve a cervical arrest. METHODS: This is a prospective, controlled, non-interventional, post-market, monocentric, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured before and after placement of a pessary in singleton pregnancies with cervical shortening in the mid trimester. In order to assess reference values for cervical stiffness, we measured also singleton pregnancies with normal cervical length in the same gestational week spectrum. The cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) shall be the primary endpoint, whilst patient delivery data (gestational age, mode of delivery and complications) will be the secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) to complete the study; pessary cohort: 60 (up to 71 recruited), control group: 60 (up to 71 recruited). DISCUSSION: Our hypothesis is that patients with cervical shortening will present with lower CSI values and that pessary placement will be able to stabilize the CSI values through further prevention of cervical remodelling. The measurement of controls with normal cervical length shall serve as a reference.


Assuntos
Nascimento Prematuro , Incompetência do Colo do Útero , Gravidez , Humanos , Feminino , Recém-Nascido , Pessários/efeitos adversos , Nascimento Prematuro/etiologia , Estudos de Coortes , Estudos Prospectivos , Projetos Piloto , Colo do Útero/diagnóstico por imagem
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