223 Clinical Trials for Various Conditions
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia. Further, we will add an exploratory outcome to evaluate the neonatal body composition and anthropometric data to better understand neonatal impacts of maternal metabolic dysfunction.
Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Gestational Complications
Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. Importantly, women who had preeclampsia have an exaggerated vascular responsiveness to hypertensive stimuli, such as high-salt intake, compared to women who had a healthy pregnancy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. While the association between a history of preeclampsia and vascular dysfunction leading to elevated CVD risk is well known, the mechanisms underlying this dysfunction remains unclear. The purpose of this study is to examine the role of vascular mineralocorticoid receptor, the terminal receptor in the angiotensin system that contributes to blood pressure regulation, in mediating exaggerated microvascular endothelial dysfunction before and after a high-salt stimulus. This will help us better understand the mechanisms of microvascular dysfunction these women, and how inhibition of these receptors may improve microvascular function. In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickel-sized area of the skin.
Preeclampsia, Preeclampsia Postpartum
Though cardiovascular disease (CVD) is the leading cause of mortality in women, traditional epidemiology in this area has focused on later life, when cardiometabolic risk has already exacted a cumulative toll on the vascular system. Recent data from the investigators and others has highlighted pregnancy as a unique, early moment of cardiovascular stress in young women that may "unmask" CVD propensity. It is unclear if PreE simply represents a "failed stress test" or directly contributes to the pathophysiology of future CVD. While mechanistic studies have largely been the purview of model-based studies, endothelial dysfunction has emerged as central to the pathogenesis of both PreE and peripartum cardiac dysfunction. Indeed, biomarkers of endothelial dysfunction and angiogenic imbalance during pregnancy have been shown to remain elevated at least 6 months post-partum. Moreover, peri-partum endothelial dysfunction can persist for years post-delivery and remains a significant risk factor for CVD (even after adjustment for other traditional risk factors). While these findings suggest that PreE-associated endothelial dysfunction and inflammation may contribute to early myocardial dysfunction that presages HF risk decades before its onset, the modifiable epidemiology of PreE-associated LVDD, including potential mechanisms of risk, remains unclear, limited by lack of precision molecular phenotypes accessible in a large number of American women across race. Ultimately, understanding the epidemiology and pathobiology of PreE-associated myocardial dysfunction affords a unique opportunity to identify women at risk with a longer lead-time for risk factor modification to interrupt CVD. The investigators hypothesize that persistent structural-functional myocardial alterations after PreE are linked to pre- and post-gravid cardiometabolic risk factors (SA1), functional and hemodynamic impairment (SA2) and select pathways of vascular and inflammatory stress relevant to HF risk (SA3). Despite extensive study on the role of inflammation/ischemia in PreE, there have been no large studies connecting these phenotypes with early PP functional response and biochemical alterations, a key barrier to designing studies for improving CVD/HF in women. SA1: To identify pregnancy-specific clinical factors related to postpartum HFpEF phenotypes Clinical Implication: Improve identification of women at highest risk for developing post-PreE LV diastolic dysfunction (a harbinger of HFpEF). SA2: To define functional and hemodynamic signatures of early HFpEF due to preeclampsia Clinical Implication: Identify women at highest risk for developing early HFpEF. SA3: To identify shared pathophysiologic mechanistic pathways for PreE-associated HFpEF Clinical Implication: Identify targetable pathways for post-PreE cardiac dysfunction that may prevent/ delay HFpEF development.
Preeclampsia, Heart Failure Preserved Ejection Fraction, Hypertension
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Preeclampsia (PE)
The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves.
Preeclampsia, Eclampsia, HELLP Syndrome, Toxemia, Hypertensive Disorder of Pregnancy
Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.
Preeclampsia, Preeclampsia Severe, Preeclampsia Mild, Preeclampsia Postpartum
The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia.
Preeclampsia Severe, Pre-Eclampsia, Preeclampsia, Preeclampsia Second Trimester, Preeclampsia Complicating Childbirth, Preeclampsia Puerperium, Preterm
Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
Preeclampsia
Otherwise healthy women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during preeclampsia and persists postpartum, despite the remission of clinical symptoms. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women. The purpose of this study is to examine differences in the microvascular balance of angiotensin II receptors women who have had preeclampsia. This will help the investigators better understand the mechanisms of dysregulated angiotensin II receptors in formerly preeclamptic women, and how activation or inhibition of these receptors may restore microvascular function. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.
Preeclampsia
The goal of this observational trial is to determine the resting cardiac output (CO) using transthoracic echocardiography (TTE) in a cohort of people with untreated preeclampsia, and a cohort of healthy normotensive pregnant people.
Preeclampsia
The purpose of this research study is to evaluate the effect of low-dose aspirin on recovery from severe preeclampsia (a high blood pressure disorder of pregnancy) among women who have given birth. We hypothesize that taking aspirin for the first week after giving birth will enhance recovery from preeclampsia by decreasing the levels of a protein called soluble fms-like tyrosine kinase (sFlt-1), which is thought to be a main contributor to the development of preeclampsia, and speeding up return to a normal blood pressure.
Preeclampsia Postpartum
Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.
Preeclampsia
The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong pregnancy.
Preeclampsia, Gestational Hypertension, Hypertensive Disorder of Pregnancy
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
Preeclampsia, Pregnancy Related
This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.
Preeclampsia
Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.
Preeclampsia
In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P \<0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.
Pre-Eclampsia
There are data showing that a majority of pregnant women may not be accurately identified as high risk through screening and therefore, not receiving prophylactic low dose aspirin as recommended. This leads to missing many patients who would benefit from aspirin administration. Aspirin is an effective, affordable and safe intervention and its universal use in pregnancy has been proposed as the answer to help mitigate risk of significant morbidity from preeclampsia. However, adherence to aspirin in women at low risk compared to those deemed at high risk of preeclampsia has never been studied. One of the arguments against universal aspirin administration is the concern that universal receipt would change the compliance in those at high risk although there are no data to support this concern. To address the lack of data on differences in adherence, our goal in this proposal is to assess whether there is a difference in adherence to low dose aspirin (81 mg) in women at high risk of preeclampsia as indicated by USPSTF risk algorithm when compared to those women randomized to universal use.
Medication Adherence, Preeclampsia
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.
Preeclampsia, Severe Preeclampsia, Eculizumab, HELLP, HELLP Syndrome, HELLP Syndrome Second Trimester, Pregnancy Related, AHUS, PNH, Complement Regulatory Factor Defect, Complement Abnormality, HELLP Syndrome Third Trimester
This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.
Preeclampsia Postpartum
Preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. An important discovery has been made by Dr Craig D Scoville showing that early Tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more than 50%. A prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.
Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction
The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.
Preeclampsia, Hypertension in Pregnancy
According to U.S. Pharmacist® "low-dose aspirin refers to dosages between 81 mg and 325 mg taken every day to prevent heart attacks, strokes, and colon cancer." It has been found through research that low-dose aspirin also decreases the risk of preeclampsia. The American College of Obstetrics and Gynecologists (ACOG) recommends low-dose aspirin (81mg/day) for women at high risk of preeclampsia. However, some researchers report that a dose of aspirin \< 100 mg/day does not seem to decrease the risk of preeclampsia. Another trial studying patients who are at a high risk for preterm preeclampsia, reported a reduction in the occurrence of preeclampsia among patients taking aspirin at a dose of 150 mg. The purpose of this pragmatic randomized study is to compare the difference in the effectiveness of two doses of aspirin: 81 mg versus 162 mg in the prevention of preeclampsia in pregnant women who are at a moderate to high risk for developing preeclampsia.
Preeclampsia
Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in/ex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease.
Preeclampsia
Preeclampsia (PE) is a morbid and potentially lethal complication of pregnancy and is more common in women with specific risk factors. Aspirin (ASA) is currently the only prophylactic therapy for preeclampsia in high-risk women to be recognized by the US Preventive Task Force and should be initiated early in the second trimester of pregnancy, before 16 weeks of gestation. However, currently there is no literature comparing various low-dose ASA formulations in the risk reduction of PE. In the United States, the currently available low-dose ASA is over the counter and is found in 81mg tablets. Therefore, when clinicians initiate therapy with low dose ASA, they may prescribe 1 or 2 tablets of 81mg aspirin per day depending on personal preference and cannot be assisted by evidence to guide their decision.This study aims to determine the incidence of preterm PE or PE with severe features in women taking either 81mg or 162mg in a randomized setting, from a single center. The investigators hypothesize that the information gained from this trial will permit a more accurate sample size calculation for a larger clinical trial powered to accept or reject our testing hypothesis. If our hypothesis is rejected and 162mg of daily ASA is not associated with a lower incidence of severe or preterm PE compared to 81mg, this may be due to lack of power to detect a smaller effect. The investigators would then evaluate the feasibility and results and determine whether a larger trial is reasonable.
Preeclampsia
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.
Preeclampsia, Obstetric Labor Complications, Hypertension in Pregnancy
Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.
Pre-Eclampsia
Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high recurrence risk and a rapid, occult progression to cardiovascular disease after delivery. There is a critical need for effective interventions to reduce these risks. This is a pilot randomized controlled trial of a novel postpartum lifestyle intervention compared to women who take home blood pressure measurements and women with usual care who are overweight and obese in the first year after preeclampsia. The investigators hypothesize that the intervention will lead to improved weight loss and blood pressure in the first year postpartum, which has broad implications for future pregnancy and long-term cardiovascular health.
Preeclampsia, Gestational Hypertension, Hypertension, Obesity, Overweight and Obesity, Pregnancy Complications, Pregnancy Toxemia, Postpartum Preeclampsia
Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
Preeclampsia
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.
Preeclampsia