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Showing 1-7 of 7 trials
NCT07015203
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic. The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical syndromes (preeclampsia, fetal growth restriction, preterm labor and intrauterine fetal demise "IUFD") and structural congenital defects (morphological and chromosomal). The primary objective of the project is to create a unified methodology for performing and evaluating the combined first trimester screening in connection with the National Health Information System (hereinafter referred to as "NHIS"), which will enable recording, providing analysis and linking recorded clinical parameters with data in the NHIS. The pilot project will also provide data for modeling appropriate mechanisms for reimbursement from public health insurance.
NCT07485140
The goal of this clinical study is to learn if a new first-trimester screening program can better find pregnant women who are at high risk of developing preeclampsia and help prevent the condition with early treatment. Preeclampsia is a pregnancy condition that causes high blood pressure and can affect the mother's organs and the baby's growth. Early detection allows doctors to offer preventive treatment, such as low-dose aspirin, which may lower the risk of serious illness. The study includes pregnant women with a single pregnancy who attend their routine first-trimester scan at maternity hospitals in Denmark. The main questions it aims to answer are: Does the new screening program lower the number of women who develop preterm preeclampsia (preeclampsia before thirty-seven weeks of pregnancy)? Can the screening program be carried out safely and be acceptable for pregnant women and healthcare professionals? Researchers will gradually introduce the new screening program across hospitals and compare outcomes before and after the program starts. Women who are found to have a high risk of preeclampsia will be offered preventive treatment with low-dose aspirin. Participants will: Receive information about preeclampsia and the screening during their first-trimester visit Have their blood pressure measured and an ultrasound assessment of blood flow to the uterus during the routine scan Have routine blood samples analysed to estimate their personal risk of preeclampsia Be offered daily low-dose aspirin until late pregnancy if they are identified as high risk Continue standard pregnancy care while researchers follow pregnancy outcomes using national health records The study will help researchers understand whether this screening approach works in everyday care and whether it should become part of routine pregnancy care in Denmark.
NCT07463898
The goal of this study is to find and confirm blood-based markers (called proteins) that may show early heart changes in women with preeclampsia, even before symptoms appear. It will also use heart ultrasound (echocardiography) to look at patterns of how the heart changes during pregnancy in women with preeclampsia. The main questions it aims to answer are: * Do these blood markers relate to heart changes on ultrasound? * How may they help predict future health problems for the mother? Participants will: * Complete a 20-minute survey that will include taking your baseline demographic information, clinical information/medical history, asking about pre-existing health conditions, including measuring your height, weight, and blood pressure. * Have transthoracic echocardiography (TTE) performed at 12 - 16 weeks gestation and again at 28 - 32 weeks gestation. * Provide a blood sample for these protein measurements. These samples will be collected at intake (12 - 16 weeks gestation) and again at 28 - 32 weeks gestation.
NCT07356817
In this project, the investigators aim to study how all these factors determine the cardiovascular status of a total of 1,800 mothers, 3 to 6 years after delivery. In addition, the investigators want to assess whether lifestyle and living conditions after childbirth may improve or worsen this imprint, since women often prioritize their families over themselves, making it more difficult to maintain a healthy lifestyle that could reduce their cardiovascular risk. Furthermore, the investigators will evaluate how environmental exposures influence their health, as well as explore potential strategies for prediction and prevention. The goal is to develop an easy-to-use algorithm or test that allows women and their physicians to assess this risk, ideally in the form of a mobile app. Although predictive algorithms for cardiovascular health already exist, most have been developed using predominantly male or older populations, and none have taken into account pregnancy-related events or environmental exposure - both of which are key determinants of women's cardiovascular health.
NCT07178652
The IMMUN-OR study aims to study HLA-C/KIR combinations when looking at the risk of development of preeclampsia (PE) in pregnancies after oocyte donation. With the use of oocyte donation currently on the rise, the importance of identifying risk factors for the higher frequency of PE development is clear. Certain HLA-C/KIR combinations have already been linked to higher risk of obstetric complications. This study will look at these combinations within the specific situation of oocyte donation. This will further investigate the importance of the immunological interface when looking at PE. Participants will be chosen from a database of all the live births after oocyte donation at our center. The research team will contact the mother, child and donor. If all three agree to participate, they will be invited to our center, where the research team will take a cheek swab. This swab will then be used to isolate a DNA sample. With these samples, we can determine the HLA-C/KIR combination for each threesome. When all samples have been collected, two groups are made based off their health outcome: one group that did develop PE during their pregnancy, and one group that did not develop PE. The different HLA-C/KIR combinations will be compared, and the research team will look to discover if one combination is linked to a higher occurrence of PE development.
NCT06759545
This study explores the potential benefits of Extra Virgin Olive Oil from early harvested olives (EVOOEH) in reducing the risk of preeclampsia (PE) in high-risk pregnant women. EVOO, particularly EVOOEH, is rich in antioxidant compounds, including polyphenols, which may help improve vascular health and reduce oxidative stress, potentially preventing complications like PE. The hypothesis is that EVOOEH may reduce microvascular damage, improve placentation, and prevent dysglycemia, ultimately lowering the risk of PE and gestational diabetes mellitus (GDM). The primary objective of this intervention is to evaluate the effect of EVOOEH on PE incidence during pregnancy, specifically assessing the impact on markers of PE, GDM, and other pregnancy-related outcomes. The study is designed as an interventional, randomized, parallel-assignment dietary trial involving 156 pregnant women at high risk for PE, aged 18 to 45. Participants will receive either a daily dose of 42 ml (three tablespoons) of EVOOEH or the Ministry of Health (MOH) general dietary recommendations for pregnancy for four weeks, starting between 8 to 16 weeks of gestation. The study arms are as follows: EVOOEH arm: Participants will consume 42 ml of EVOOEH daily along with MOH dietary recommendations for four weeks (n=78). Control arm: Participants will follow only the MOH dietary recommendations for four weeks (n=78). The intervention will occur alongside low-dose aspirin prophylaxis for PE prevention, as recommended by guidelines for women at high risk. Key compliance markers include adherence to a Mediterranean diet as measured by the Mediterranean Diet Adherence Screener (MEDASIS) and hydroxytyrosol levels in maternal blood. The study will mask data analysis to minimize bias. The primary outcome measures are maternal glucose challenge test (GCT) results and the serum soluble FMS-like tyrosine kinase 1/placental growth factor (sFlt-1/PlGF) ratio at the end of the intervention. Secondary outcomes include the incidence of GDM, PE, cesarean sections, preterm delivery, small for gestational age (SGA) births, blood pressure measurements, gestational age at delivery, and any relevant data available from participants' medical records. Eligibility criteria include pregnant women with risk factors for PE such as a history of PE, chronic hypertension, obesity, or diabetes, among others, and a gestational age between 8 to 16 weeks. Exclusion criteria involve low-risk pregnancies or women who refuse participation. Blood samples will be collected to assess 25-hydroxyvitamin D (25(OH)D), hydroxytyrosol (HT), and the sFlt-1/PlGF ratio. Laboratory analyses will be conducted at Barzilai University Medical Center and the Weizmann Institute of Science. This study seeks to determine whether EVOOEH's higher polyphenol content compared to standard EVOO can offer additional protective benefits against PE and related complications in high-risk pregnancies.
NCT06791668
The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is: What are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia? Participants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.