Clinical Research Directory

MH-Rx Study (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)

This randomized controlled trial will evaluate whether adding Community Health Worker (CHW)/Social Worker (SW)-led support for non-medical health related needs (NMHRN) and clinician-led Medication Therapy Management (MTM) to remote blood pressure monitoring improves outcomes for pregnant women with chronic hypertension or gestational hypertension (i.e high blood pressure that was present before pregnancy or developed during pregnancy). All participants will monitor their blood pressure at home, use the TSU MH Rx app, and complete assessments related to social needs, depression, anxiety, pregnancy care experiences, and satisfaction. Only participants in the intervention group will receive targeted virtual social needs support and virtual regular MTM sessions focused on medications, self-care, adherence, and risk reduction. The study will assess blood pressure and maternal outcomes, feasibility, and participant satisfaction with the combined intervention.

Retinal and Choroidal Microcirculation in Preeclampsia: An OCTA Study

Preeclampsia is a multisystemic and multifactorial disorder that complicates pregnancy and is characterized by new-onset hypertension after the 20th week of gestation accompanied by proteinuria or systemic findings such as renal dysfunction, hepatic dysfunction, pulmonary edema, thrombocytopenia, or neurological symptoms including headache and visual disturbances. It represents a significant risk factor for maternal and fetal morbidity and mortality. In normal pregnancy, trophoblasts invade and dilate the maternal spiral arteries, thereby increasing uteroplacental blood flow. In preeclampsia, however, inadequate trophoblastic invasion leads to defective placentation, resulting in uteroplacental hypoperfusion and ischemia. The hypoxic and ischemic placenta releases anti-angiogenic mediators into the maternal circulation, which disrupt maternal endothelial function. This endothelial dysfunction results in vasoconstriction, microthrombosis, and increased vascular permeability. Consequently, hypertension, renal and hepatic dysfunction, pulmonary edema, and neurological symptoms may develop in maternal organ systems. The endothelial dysfunction observed in preeclampsia can also affect the microvascular structures of the eye, leading to circulatory disturbances at the level of the retina and choroid. Disruption of endothelial integrity, together with vasospasm and microthrombus formation, may cause reduced perfusion in the retinal and choroidal microcirculation, forming the basis of the ophthalmic manifestations of preeclampsia. Clinically, this condition may present with visual disturbances, blurred vision, scotomas, retinal edema, and choroidal thickening. These microvascular changes can be evaluated noninvasively in outpatient settings using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA). OCT and OCTA allow high-resolution imaging of retinal and choroidal structures and enable quantitative assessment of vascular parameters such as vessel density, the size of the foveal avascular zone (FAZ), and choriocapillaris flow voids. Through these techniques, microvascular hypoperfusion, loss of vascular integrity, and ischemic areas caused by endothelial damage associated with preeclampsia can be objectively identified. The aim of this study is to evaluate ocular vascular changes associated with preeclampsia using OCT and OCTA

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.

Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)

Hypertensive disorders of pregnancy frequently fail to resolve at delivery. A substantial proportion of women remain hypertensive at the six-week postnatal review, postpartum eclampsia occurs days to weeks after birth, and a minority show persisting renal dysfunction. Attendance at postnatal follow-up is nonetheless poor and specialist resources are limited, so a simple bedside test that identified the women whose cardiovascular recovery is incomplete would allow surveillance to be targeted. Ophthalmic artery Doppler is non-invasive, takes about five minutes and requires only a linear transducer already present in obstetric units. Its antenatal performance is well characterised, but a systematic review by this group (PROSPERO CRD420261488689) identified only three studies in thirty years addressing the postpartum period, two of which included a normotensive comparator, totalling 131 women. None reported a threshold or any measure of diagnostic accuracy, and none recorded antihypertensive treatment at the time of scanning. This prospective cohort study will measure ophthalmic artery Doppler indices at four timepoints between delivery and three months in women with hypertensive disorders of pregnancy and in normotensive controls, and will determine whether the peak systolic velocity ratio measured 24 to 48 hours after delivery predicts persistent hypertension at the six-week postnatal review.

Pregnancy Salt Substitution Trial for Hypertensive Disorders of Pregnancy Prevention (PREG-Salt)

The PREG-Salt study is to evaluate the effect, safety and cost-effectiveness of low-sodium salt in reducing blood pressure and preventing hypertensive disorders in pregnant women at high risk in China. The study will recruit about 3,200 participants from approximately 100 hospitals across multiple provinces in China. Eligible pregnant women (≤16 weeks of gestation) will be randomly assigned in a 1:1 ratio to the following 2 groups: 1. Salt subsittute(intervention); 2. Usual salt (control) . The intervention will last until delivery. The study employs an adaptive two-phase design. An interim analysis after the first phase (n=400) will inform whether the trial continues into the second phase and if any adjustments to the sample size are needed. The primary outcomes are: Phase 1: The mean systolic blood pressure across antenatal visits (excluding the last week before delivery). Phase 2: New-onset hypertensive disorders of pregnancy and related adverse events from randomization to delivery.

Cardiometabolic Risk in Pregnancy and Postpartum

The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.

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.

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation. The participants are included in of of two cohorts. One includes women pregnant after oocyte donation whereas the other includes women pregnant after IVF treatment with autologous oocytes. Participants will be followed throughout pregnancy with blood samples, blood pressure, clinical controls and ultrasound examinations. Clinical outcomes will be registered post-partum.

Exploring Reproductive Health Among Women in Somaliland

Somaliland faces persistently high burdens of maternal and perinatal mortality, with limited population-based data on pregnancy complications, sociocultural influence on maternal health, and women's reproductive health needs across the continuum of pregnancy, childbirth, and postpartum. Existing maternal near-miss (MNM) tools are largely facility-based, and evidence of postpartum contraceptive uptake and interventions remains scarce. In response, the objective of this study is to unfold the physical, cultural, and psychosocial strengths and challenges experienced by women in Somaliland during pregnancy, childbirth, and the postpartum period; to examine how these factors interact to influence pregnancy outcomes and women's ability to achieve future reproductive health goals; and to pilot how these insights can inform the co-creation of context-appropriate health materials. The PROMISE study is a community-based longitudinal pregnancy cohort in Hargeisa, Somaliland, including approximately 800 pregnant women \<28 weeks of gestation recruited from randomly selected sub-districts. Women will be followed up at three time points (early pregnancy, late pregnancy, and postpartum) using questionnaires and clinical measurements. A MNM tool will be adapted through a Delphi process, and its validity will be tested using the cohort. The cohort findings will inform a co-creation process to develop postpartum contraceptive counselling materials to be pilot-tested for feasibility, acceptability, and preliminary effects. This protocol responds to major evidence gaps in fragile and low-resource contexts, and aims to generate contextually grounded knowledge and co-created interventions to strengthen maternal health policy, practice, and reproductive agency in Somaliland and beyond.

Evaluation of sFlt-1/PlGF Ratio ,OPG and sEng as Predictive Biomarkers in the Diagnosis and Treatment Evaluation of Preeclampsia

his study investigates the effectiveness of three specific biological markers (biomarkers) in the blood-the sFlt-1/PlGF ratio, soluble endoglin (sEng), and osteoprotegerin (OPG)-to better diagnose and monitor preeclampsia. Preeclampsia is a serious pregnancy complication characterized by high blood pressure and potential organ damage that affects 2-8% of pregnancies worldwide

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.

Vitamin D and Hypertensive Disorders of Pregnancy

The purpose of this study is to further investigate the association between vitamin D deficiency/insufficiency and hypertensive disorders of pregnancy by studying the impact of screening for vitamin D deficiency and supplementation when low levels of vitamin D are detected. Screening for vitamin D deficiency (less than 20 ng/mL) and insufficiency (less than 30 ng/mL) may determine the need for additional supplementation, as most prenatal vitamins only contain 400 IU of vitamin D. The rates of hypertensive disorders of pregnancy amongst patients who received supplementation and maintained adequate vitamin D levels will be followed.