Clinical Research Directory

mHealth for Hypertensive Disorder of Pregnancy

Objectives: We have developed a cardiovascular disease management application named Heart4U, with the capability of integrating with the Electronic Medical Records (EMR) system within the hospital. The main goal of this study is to evaluate the clinical effectiveness of a treatment approach that entails self-management of risk factors through a mobile application among pregnant individuals diagnosed with hypertensive cardiovascular conditions. Methods: Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage. Both the app group and the usual care group continue to receive active treatment as previously administered (guideline-based prenatal care). Follow-up observations occur at each obstetric examination prior to delivery and are conducted again at the first month postpartum. The primary endpoint of observation pertains to the difference in systolic blood pressure between the enrollment and study completion time points.

Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

This study explores a novel approach to improving care for postpartum patients with preeclampsia, a pregnancy-related condition characterized by high blood pressure, protein in the urine, and organ dysfunction. Preeclampsia affects up to 9% of pregnancies and can progress to include complications of seizures, stroke, and even death. Over 60% of patients with preeclampsia continue to experience high blood pressure at the time of discharge from their delivery hospitalization, and many of these patients require blood pressure medications for up to 6 months postpartum. Even with blood pressure medications, many of these patients are readmitted to the hospital within six weeks of delivery. In this study, the investigators will utilize point-of-care ultrasound (POCUS), a quick and non-invasive, bedside imaging strategy, to look for signs of excess fluid accumulating in the lungs and venous system of postpartum patients with preeclampsia. Because excess fluid has the potential to worsen blood pressure, subjects with evidence of this on POCUS would be treated with a diuretic medication called furosemide (either orally or intravenously) within 24 hours of delivery. The investigators' main goal is to determine whether using POCUS can help physicians make better treatment decisions and improve short-term outcomes for postpartum patients with preeclampsia. The investigators' aim to achieve faster recovery of blood pressure, reduce the need for blood pressure medication at hospital discharge, and lower the rates of hospital readmission for those with preeclampsia. This study could significantly enhance the overall care and health of postpartum patients.

The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia

This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group \[Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg\])

MR and Inflammation After Preeclampsia

The purpose of this investigation is to examine the role of inappropriate mineralocorticoid receptor activation in endothelial dysfunction and vascular inflammation in otherwise healthy women with a history of preeclampsia. The main questions it aims to answer are: 1. Does overactivation of the mineralocorticoid receptor contribute to reduced endothelial function in women who had preeclampsia? 2. To what extent does the mineralocorticoid receptor mediated exaggerated production of inflammatory cytokines in immune cells from women who had preeclampsia? Participants will visit the research laboratory for 2 experimental visits: * Visit 1: Skin blood flow will be measured using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) to examine blood vessels in a nickel-sized area of the skin. * Visit 2: Endothelial cells will be collected from an antecubital vein.

Daily Aspirin Treatment After Preeclampsia

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.

Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia

Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.

Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure

High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care. A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support. The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.

Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

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.

Blood Pressure Goal in Preterm Preeclampsia

The purpose of this study is to compare latency (prolongation of pregnancy from diagnosis till delivery) in patients with hypertensive disorders of pregnancy (HDP) with severe features \< 34 weeks gestational age (GA), undergoing expectant management between tight and permissive blood pressure (BP) groups.

AtorvaStatin Postpartum and Reduction of Cardiovascular risK

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.

Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.

MumCare: Mum's Cardiovascular Health for Life

The goal of this randomized clinical trial study is to test the potential benefits of eHealth-assisted follow-up after pregnancy complications that confer and increased risk for premature cardiovascular (CV) disease. The overarching aim is to improve short- and long-term CV health in women following pregnancy complications associated with increased risk of CV disease (hypertensive disorders of pregnancy and gestational diabetes). The investigators will develop and test a novel, personalized and user co-designed digital eHealth companion ("app") and test the app in a clinical randomized control trial. The group randomized to app use will get access to the app prior to delivery or within the first weeks postpartum, whereas the control group will not get access to the app, but receive ordinary follow-up. Both groups are invited to a comprehensive cardiovascular follow-up 14-18 months post delivery. The primary objective is to assess whether the rate of 1-year postpartum follow-up at the general practitioner's is increased with MumCare app access. Secondary objectives are to assess: 1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies, 2. if health perception, sense of empowerment (self-management evaluation and general self-efficacy), modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight, physical activity), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.

Molecular Study of the Maternal-fetal Interface in Preeclampsia.

Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in maternal-fetal interface tissue (chorionic villi + decidua) collected during gestational weeks 9 to 15. Maternal-fetal interface biopsy will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.

MitoQ to Improve Vascular Funciton in Preeclampsia

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage. Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve placental function, and therefore promote pregnancy prolongation in patients with gestational hypertension (gHTN) and/or preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with gHTN and/or preeclampsia could translate into a viable therapeutic option.

Comparison of Pregnancy Outcomes in Primigravida Receiving Low-Dose Aspirin for the Prevention of Preeclampsia.

Local data on the effectiveness of low-dose aspirin in high-risk primigravida are limited. The present study was planned to compare pregnancy outcomes between high-risk primigravida receiving low-dose aspirin (75 mg/day) from 12 weeks of gestation and those not receiving aspirin.

Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study

ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\] and risk of adverse outcomes.

Norepinephrine Infusion vs Bolus vs Ephedrine for Blood Pressure Stability During Cesarean Delivery in Women With Preeclampsia

This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.

Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

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.

PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia

Preterm preeclampsia is a severe condition for both the mother and the fetus. Currently, the only treatment available to stop disease progression is termination/delivery of the fetus and placenta. Therefore, preterm preeclampsia carries the highest rates of neonatal morbidity and mortality due to iatrogenic preterm birth. There is evidence suggesting metformin, a drug commonly used to treat diabetes in and outside pregnancy, may be able to counter the pathophysiology of preeclampsia, raising the possibility that it could be used to treat the condition. This multi centre double blind randomised controlled trial aims to investigate if metformin can prolong gestation, lower neonatal length of stay and increase birthweight in a Nordic setting.

Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation

Pregnancy complications such as pre-eclampsia (high blood pressure during pregnancy), poor fetal growth, unexplained stillbirth, and spontaneous preterm birth are major causes of illness and death for mothers and babies in sub-Saharan Africa. These conditions, known as the Great Obstetrical Syndromes, are thought to result from problems with the development of the placenta early in pregnancy. However, there is limited information from African populations to help identify women at risk or improve prevention and treatment. This study will enroll 4,000 first-time pregnant women in Uganda before 18 weeks of pregnancy and follow them throughout pregnancy until delivery. Participants will attend routine study visits where information about their health, pregnancy, and social circumstances will be collected. Physical examinations, ultrasound scans, and blood samples will be obtained at several time points during pregnancy, and blood and placental samples will be collected at birth. Some samples will be analyzed during the study, while others will be stored for future research with appropriate ethical approval. The study will examine which clinical, biological, and social factors are associated with pregnancy complications. Researchers will use statistical methods and artificial intelligence (AI) techniques to identify patterns that may help predict which women are at increased risk of developing these conditions. The knowledge gained from this study may support the development of better screening tools and strategies for preventing pregnancy complications, improve maternal and newborn health outcomes in Uganda and other African settings, and establish a valuable biobank to support future maternal and newborn health research.

Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes

Objective: This study aims to investigate the association between maternal serum placental growth factor (PLGF) and nucleosome levels in early pregnancy and adverse pregnancy outcomes, and to evaluate their predictive value for the occurrence of preeclampsia, fetal growth restriction, preterm birth, and other pregnancy complications. Method: This observational prospective cohort study enrolls pregnant women who undergo non-invasive prenatal testing (NIPT) at 12-14 weeks of gestation and deliver at the Second Affiliated Hospital of Wenzhou Medical University between June 2026 and July 2027. Maternal peripheral blood samples are collected for NIPT analysis, and plasma nucleosome concentrations and PLGF levels are measured. Participants are categorized into four groups based on the 95th percentile (P95) of nucleosome and PLGF levels established from a healthy pregnant population at the same center during the same period: (1) both normal, (2) elevated nucleosome only, (3) elevated PLGF only, and (4) both elevated. Maternal demographic characteristics, laboratory indicators, and pregnancy outcomes are collected and compared across groups. The incidence of adverse pregnancy outcomes, including preeclampsia, fetal growth restriction, preterm birth, recurrent miscarriage, and neonatal complications, is recorded. The relationship between nucleosome and PLGF levels and adverse pregnancy outcomes is analyzed to explore their potential as early predictive biomarkers for placental dysfunction-related complications.

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.

Internal Jugular Vein Collapsibility Index for Volume Status Assessment in Preeclampsia in Correlation With Normotensive Parturients

This study aims to assess and analyze volume status in preeclamptic patients and compare these parameters with those of normotensive pregnant ones based on the change in internal jugular vein ultrasound-based indices.