81 Clinical Trials for Various Conditions
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.
The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent chronic hypertension-a potent contributor to disparate mortality among Black women. * To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, MFeast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only). * To test sustainability and scalability. Participants will: * Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3 and 6 months post-delivery after the baseline survey. * Submit anthropometric data (e.g. weight and blood pressure)
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a postpartum physical activity intervention after a pregnancy complicated by a Hypertensive Disorder of Pregnancy. The study will also assess the effects of the remote postpartum intervention on blood pressure. To do this, we will recruit individuals that are 3-6 months postpartum a pregnancy complicated by a hypertensive disorder to participate in a 4-month health coaching intervention aimed to promote physical activity and was informed by formative work done previously.
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.
Determine the presence of the human sequence of Angiotensin-(1-12) in plasma of ten untreated hypertensive subjects and after 4 week with Lisinopril 40 mg every day. Determine the blood pressure reduction with Lisinopril 40mg.
The literature unequivocally supports follow-up in the postpartum period post hospital discharge in hypertensive patients, compared to uncomplicated delivery follow-up recommendations of 4-6 weeks postpartum, leading to decreased morbidity and mortality, utilizing at-home blood pressure monitoring and virtual/telemedicine appointments. There is much evidence that telemedicine visits are equally, if not more effective, result in cost savings, and are generally preferred by patients, specifically when there is a risk of exposure for the patient and newborn, an appropriate factor to consider amidst the global Covid-19 pandemic. Maternal health and well-being have substantial links with cultural and racial factors. Black women are three times as likely to have morbid outcomes related to gestational complications, specifically hypertensive disorders of pregnancy. Minority populations have historically displayed inferior access to care due to concerns related to transportation, healthcare insurance, or provider accessibility and distrust, resulting in diminished compliance with follow-up and negative health sequelae. Telemedicine follow-up within 10 days of delivery (48-72 hours after discharge) reduces readmission rates, increase access to- and compliance with care, and improve patient safety satisfaction, thus establishing feasibility. Home vital sign monitoring gives an increased volume of data points for providers to utilize in titrating antihypertensive medications to optimize blood pressure control, ultimately decreasing stroke and cardiovascular risk. Existing research lacks comprehension regarding specific cardiological impacts of labile postpartum blood pressures, however researchers inferentially hypothesize that poor blood pressure management in the postpartum period can have devastating long-term cardiological consequences. This QI project will demonstrate standardized programming for patients with hypertensive disorders of pregnancy (HDP), which may potentially lead to increased compliance, satisfaction, and accessibility, resulting in improved long-term cardiovascular health in vulnerable populations. The American heart Association (AHA) and ACOG have established that HDP are associated with long-term cardiovascular disease, however obstetricians lack guidance on effective, evidence-based research for standardization of care, leading to subsequently disjointed medical management with much room for error in transitioning from obstetrician to internist or cardiologist. Thus, implementing and establishing feasibility of remote monitoring and follow-up while applying standardized algorithms and protocols for antihypertensive medication titration and management may provide support in addressing and eradicating these gaps. As such, this pilot project has massive prospective future applicability and benefit for a highly vulnerable population.
Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
* The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders. * Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide. * The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.
This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.
This study aims to assess the prevalence of sleep disorder breathing in pregnant women with a singleton gestation who develop hypertensive disorder of pregnancy (HDP) compared to women without HDP, when matched for gestational age and body mass index.
Hypertensive disorders of pregnancy (HDP) affect up to 10% of mother-infant dyads and account for 7.4% of cases of maternal mortality in the United States. Prompt recognition and treatment of hypertension remain one of the key features of management of mothers affected by these conditions. Up to 41% of severe morbidity and mortality from HDP occurs after 48 hours postpartum, as postpartum blood pressures tend to peak 3-6 days after birth. For these reasons, early postpartum follow-up is recommended for women diagnosed with HDP, in the form of blood pressure (BP) evaluation by a health care provider at 7-10 days postpartum (2-5 days post-discharge from maternity care). However, barriers to follow-up limit mothers' ability to adhere to this recommendation. A potential alternative to in-office evaluation is at-home BP monitoring. At-home BP monitoring is a novel, affordable method to empower, educate, and engage postpartum women affected by HDP. Within the obstetric (OB) population, pilot studies have demonstrated the feasibility and acceptability of remote BP monitoring. Hence, the purpose of this randomized trial is to empower postpartum women affected by HDP and cared for at North Carolina Women's Hospital to perform at-home BP monitoring with the aid of digital technology.
The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.
To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).
The overarching goal of Thriving Hearts is to implement a multi-level program through Local Health Departments (LHDs) that cultivates conditions for mothers and birthing people to not only survive pregnancy, but to thrive. Thriving Hearts is a collaboration among LHDs in ten North Carolina counties, designed to reduce incidence of Hypertensive Disorders of Pregnancy (HDP) and their complications through support and connection at the individual, healthcare provider, and community level. The investigators will conduct a pragmatic, stepped-wedge, cluster randomized study. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in clusters in a randomly assigned sequence at 9-month intervals.
The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with hypertensive disorders of pregnancy, to improve cardiovascular risk score postpartum. For this, 76 individuals with hypertensive disorders of pregnancy (HDP) will be randomized to atorvastatin 10mg or placebo, which will be started in the postpartum period after cessation of breast feeding and continued for 3 months.
Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction. Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants. Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes.
The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
This is a prospective observational cohort study of platelet phenotype in pregnant patients at high-risk for the development preeclampsia. Blood samples will be collected prior to the initiation of daily aspirin and again in the second trimester to evaluate for platelet changes during pregnancy in patient's as a result of aspirin use and their association with adverse perinatal outcomes.
Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden.
The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.
This study is designed to compare the effect of different dietary potassium sources on uptake and retention of potassium, as well as to determine the effect of potassium intake on blood pressure and acid-base balance. The study will compare three different sources of potassium given as a supplement, potatoes or French fries.
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
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.
This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.