Clinical Research Directory

Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes

This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy. Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.

A Study to Find and Confirm Blood-based Markers (Called Proteins) That May Show Early Heart Changes in Women With Preeclampsia, Even Before Symptoms Appear, and the Use of Heart Ultrasound (Echocardiography) to Look at Patterns of How the Heart Changes During Pregnancy in Women With Preeclampsia.

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.

Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR

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.

Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

Hyperspectral Imaging for Prediction of Preeclampsia

Preeclampsia is a hypertensive pregnancy disorder that can quickly lead to serious, potentially life-threatening outcomes for both the mother and the fetus. Typical features of preeclampsia are by endothelial and microvascular dysfunctionsNotably, such impairments in endothelial function may precede preeclampsia diagnosis and canpersist for years postpartum. In clinical practice, however, no predictive methods have yet been established that specifically reflect endothelial dysfunction in the context of preeclampsia. Hyperspectral imaging represents a new and non-invasive imaging modality that allows contact-free visualization of peripheral microcirculatory dynamics and tissue perfusion. Despite its growing use in other medical fields, this technology has not yet been systematically studied to determine its predictive potential in preeclampsia. The HIPPA project (Systematic Evaluation of Hyperspectral Analysis for Prediction of Preeclampsia) is a prospective observational study to evaluate the applicability of hyperspectral imaging as a new tool for prediction of preeclampsia.

An Interventional Pilot Study on the Effect of Extra Virgin Olive Oil on Women with Preeclampsia Risk

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.