Clinical Research Directory

Internal Jugular Vein Collapsibility Index for Volume Status Assessment in Preeclampsia in Correlation With Normotensive Parturients : a Prospective Observational Cohort Study

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.

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.

Progesterone Preeclampsia

This randomized controlled trial evaluates whether nightly vaginal micronized progesterone (400 mg) initiated before 12 weeks' gestation reduces the incidence of preeclampsia in low-risk pregnant individuals. Participants will be randomly assigned (1:1) to receive either vaginal progesterone through 16 weeks' gestation or routine prenatal care without progesterone. Maternal and neonatal outcomes-including development of preeclampsia, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.

The PreEclampsia Postpartum Prevention Trial

The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are: * Does the 9-month intervention reduce systolic and diastolic blood pressure? * Does the intervention promote postpartum weight loss? * Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes. All participants will attend clinical visits for outcome assessments. Participants in the intervention group will: * Receive online targeted screening and group meetings with study personnel * Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education * Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)

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.

Cardiovascular Protection After Preeclampsia With Enalapril

The purpose of this study is to learn if postpartum women are willing to be randomized to different blood pressure medicines after delivery and how that affects blood pressure in women with hypertensive disorders of pregnancy.

Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.

Role of Progesterone Membrane Receptors in the Pathogenesis of Preeclampsia

Preeclampsia is a pregnancy-specific hypertensive disorder and remains a leading cause of maternal and perinatal morbidity and mortality worldwide. Although abnormal placentation, impaired trophoblast invasion, endothelial dysfunction, and immune dysregulation have been implicated in its pathogenesis, the underlying molecular mechanisms are not fully understood. Progesterone plays a critical role in the maintenance of pregnancy through both classical nuclear receptors and membrane-associated progesterone receptors. Emerging evidence suggests that progesterone membrane receptors, including progesterone receptor membrane component 1 (PGRMC1), progesterone receptor membrane component 2 (PGRMC2), and members of the progestin and adipoQ receptor (PAQR) family, may regulate trophoblast invasion, placental development, and inflammatory responses. This study aims to compare the placental expression levels of PGRMC1, PGRMC2, and PAQR family receptors between women with preeclampsia and healthy pregnant controls and to investigate their potential role in the pathophysiology of preeclampsia.

Mobile Health Program for Post-Preeclampsia Hypertension

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

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.

Low Dose Aspirin Alerts in High-Risk Pregnancies

The goal of this study is to assess the effect of an electronic health record (EHR) clinical decision support tool, also known as a best practice alert (BPA), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. The investigators hypothesize that the implementation of the EHR BPA tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.

Vitamin D Therapy to Prevent Recurrent Preeclampsia in High-Risk Pregnancies

The goal of this clinical trial is to determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia. The main questions the study aims to answer are: \- Does daily vitamin D supplementation reduce the recurrence of preeclampsia compared with a placebo? Researchers will randomly assign 146 eligible pregnant women to receive either vitamin D supplements or a placebo. The two groups will be compared to determine whether vitamin D lowers the risk of recurrent preeclampsia. Participants will: * Be randomly assigned to receive either 4000 IU oral vitamin D once daily or a matching placebo. * Take the assigned study medication daily until 36 weeks of gestation. * Attend follow-up visits every 2 weeks for blood pressure measurement and clinical assessment. * Have serum vitamin D levels measured every 4 weeks to monitor for vitamin D toxicity. * Undergo urine testing for protein if blood pressure is elevated to assess for preeclampsia. The results of this study will help determine whether vitamin D supplementation is an effective and safe strategy for preventing recurrent preeclampsia in women at high risk.

Preventing Obstetric Complications With Dietary Intervention

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are: * Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? * Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups. Participants in the standard of care will be asked to: * Complete surveys * Biometric screenings Participants in the intervention group will be asked to: * Complete surveys * Biometric screenings * Participate in weekly personal health coaching * Receive and consume provided weekly meals. Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.

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.

Preeclampsia Postpartum Antihypertensive Treatment

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.

Excess Base Comparison Between Pregnant Subjects With Severe Preeclampsia vs. Normotensive Pregnant Women

The study's primary goal is to compare the base excess (BE) values-an indicator of metabolic changes-in two groups of patients at Santo Tomás Hospital: those with severe preeclampsia and healthy, pregnant individuals. Researchers will measure these values using an arterial blood gas test before delivery or surgery. This is a prospective cohort study. The researchers will analyze various blood gas parameters, including pH, lactate, and BE, and then correlate the BE values with clinical variables and negative maternal outcomes. The expected outcome is that a abnormal BE values will be linked to a greater severity of preeclampsia. If this association is confirmed, BE could serve as an additional marker for predicting the severity of the condition and may lay the groundwork for future research on diagnostic and therapeutic standards based on blood gas analysis.

Identification of Genes of Interest for Severe Forms of Preeclampsia

Preeclampsia is a pregnancy complication characterized by high blood pressure associated with damage to various organs, especially the kidneys. It happens in about 1 to 5% of pregnant women and can cause serious problems for both the mother and the baby. Several multi-omics studies have already been conducted on preeclampsia, with promising results. However, this is preliminary data that requires further studies. The molecular markers identified in this type of study could potentially be used, first of all, for the early screening of this condition, which is not yet reliably achievable. In addition, the knowledge gained from this research would help us better understand the pathophysiology of preeclampsia. Therefore, the investigators' goal is to carry out a multi-omics analysis of preeclampsia to uncover the genetic and molecular mechanisms involved in this condition.

Exosome Cargo From Preeclampsia Patients

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.

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.

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.

Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

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.

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.

Effects of Progressive Muscle Relaxation Exercise and Finger Grip Exercise on Stress, Anxiety, Fatigue, Sleep Quality, and Physiological Parameters in Pregnant Women With Preeclampsia

The aim of this study is to examine the effects of progressive muscle relaxation exercise and finger grip exercise on stress, anxiety, sleep quality, fatigue and physiological parameters in preeclamptic pregnant women. It is thought that the study will contribute to the improvement of sleep quality by reducing the stress, anxiety and fatigue levels of pregnant women. In this study, which will examine the effects of stress, anxiety, fatigue, sleep quality and physiological parameters of preeclamptic pregnant women, progressive muscle relaxation exercise and finger grip exercise will be used in the same study. No other study has been found where these two methods were used in the same study and the specified parameters were examined together. It is thought that the results of this study will contribute to the literature. The basic questions that the study will answer are as follows: H1: The stress level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group. H2: The anxiety level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group. H3: The fatigue level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group. H4: The sleep quality of preeclamptic pregnant women in the progressive muscle relaxation exercise group is better than that of the control group. H5: The physiological parameters of preeclamptic pregnant women in the progressive muscle relaxation exercise group are better than that of the control group. H6: The stress level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group. H7: The anxiety level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group. H8: The fatigue level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group. H9: The sleep quality of preeclamptic pregnant women in the finger grip exercise group is better than the control group. H10: The physiological parameters of preeclamptic pregnant women in the finger grip exercise group are better than the control group. H11: The effects of progressive muscle relaxation exercise and finger grip exercise on stress levels are different in preeclamptic pregnant women. H12: The effects of progressive muscle relaxation exercise and finger grip exercise on anxiety levels are different in preeclamptic pregnant women. H13: The effects of progressive muscle relaxation exercise and finger grip exercise on fatigue levels are different in preeclamptic pregnant women. H14: The effects of progressive muscle relaxation exercise and finger grip exercise on sleep quality are different in preeclamptic pregnant women. H15: The physiological parameters of progressive muscle relaxation exercise and finger grip exercise are different in preeclamptic pregnant women. Researchers will divide participants into experimental and control groups to examine the effects of progressive muscle relaxation exercise and finger grip exercise on stress, anxiety, sleep quality, fatigue and physiological parameters in pregnant women with preeclampsia. There will be 3 groups in the study. Group 1: PKGE Group Group 2: Finger Grip Group Group 3: Control Group Progressive muscle relaxation exercise will be applied to group 1, finger grip exercise will be applied to group 2, and no intervention will be applied to group 3. The data of the study will be collected with the Perceived Stress Scale, State/Trait Anxiety Scale, Richard-Campbell Sleep Scale, Visual Similarity Scale for Fatigue, Physiological Parameters, VAS Score Average.

Use of Allied-health Professionals to Improve Treatment of Disease

The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care. Participants will: Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.