Clinical Research Directory

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.

PROTECT-Africa: Biomarker Validation for Preeclampsia Triage

Preeclampsia is a serious high blood pressure condition that can develop during pregnancy. It is one of the leading causes of death and illness for mothers and babies in Africa. Doctors find it hard to tell which women with high blood pressure in pregnancy will go on to become seriously ill, because the tests available today are not accurate enough and are often not available in local clinics. Two proteins in the blood, called sFlt-1 and PlGF, may help predict who is at risk. The balance between them (the sFlt-1/PlGF ratio) has been useful in other parts of the world, but it has not been properly tested in African women. New rapid tests can measure these proteins at the clinic in minutes, using a small blood or urine sample, without a large laboratory. This study will look at how well these tests work in African women. Researchers will do two things. First, they will work out the result levels that best predict whether a woman will or will not develop severe preeclampsia in the following weeks, using a well-established laboratory test as the standard for comparison. Second, they will check how closely the rapid clinic tests match that laboratory standard. The study will also look at what these tests cost and whether using them could save money for families and health services. The study will include about 1,106 pregnant women at large maternity hospitals in Zimbabwe, Rwanda and Tanzania. Women may join if they are between 23 and 37 weeks pregnant with one baby and their care team suspects preeclampsia, for example because of raised blood pressure, protein in the urine, or symptoms such as headache, swelling or vision changes. Taking part does not change a woman's medical care in any way. Women will attend their usual pregnancy visits, plus study visits at 1 week, 2 weeks and 4 weeks, at delivery, and about 4 weeks after birth. At these visits the study team will record health information and collect blood and urine samples. About 15 ml of blood (around one tablespoon) is collected at each visit. The test results are not used to make any decisions about a woman's treatment. Doctors and nurses caring for her will not see them, and neither will she. All treatment decisions stay with her own healthcare team. Routine tests such as blood counts and liver tests are shared with her care team as usual. The results of this study may help clinics in Africa spot dangerous preeclampsia earlier, so mothers and babies can be treated in time.

Arm and Finger Measurement for Blood Pressure Surveillance

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Pregnancy in the Context of Urbanicity and Climate Change. The Overall Aim of the Project is to Co-create, Implement, and Test New Clinical Guidelines in Order to Improve the Quality of Care in Antenatal Clinics in the Context of Urbanisation and Climate Change in Dar es Salaam, Tanzania.

Tanzania's population is growing quickly, and Dar es Salaam is one of the fastest-growing cities in the world. At the same time, the city is increasingly affected by very hot weather, flooding, and air pollution. Many parts of Dar es Salaam do not have enough roads, drainage, housing, or public services for the number of people living there. About 70% of people live in unplanned neighborhoods, often in areas that are more exposed to flooding, heat, and pollution. This means many families face greater environmental risks in their daily lives. The health system has also struggled to keep up with the city's rapid growth. Maternity services are often overcrowded, and many women and children in urban Tanzania now face worse birth outcomes than those in rural areas. Poverty, large gaps between rich and poor, weak infrastructure, and congested hospitals all make it harder for pregnant women to get the care they need. This makes Dar es Salaam an important place to study how antenatal care can better respond to climate-related risks and the realities of urban life. The study is expected to provide useful lessons not only for Tanzania, but also for other countries in sub-Saharan Africa and other low- and middle-income settings. This is especially important because more than half of the world's population now lives in cities, and most future urban growth is expected to happen in Africa and Asia. The study will evaluate whether a co-created antenatal care program can improve the quality of pregnancy care and reduce serious pregnancy problems among pregnant women receiving care in government health facilities in Temeke District, Dar es Salaam, Tanzania. The program is designed for busy urban public clinics and includes guidance for pregnant women and their families, guidance for health providers, training for providers, a booklet for women, and text messages to support antenatal care visits and health information sharing. The study will be implemented in all 21 government facilities in the district that provide antenatal care and/or gynecological and childbirth care. The study will use a pre-post implementation comparison design. Researchers will compare pregnancy care and outcomes before the program is introduced with pregnancy care and outcomes after implementation. The primary outcome is antepartum stillbirth, meaning a baby dies before labor starts. Secondary outcomes are preterm birth and the quality of uncomplicated postabortion care. The study will also examine whether the program improves the quality of antenatal care by helping health providers better identify and manage problems in pregnancy, especially high blood pressure disorders and early pregnancy complications such as miscarriage, and by improving women's understanding of key health information, the timing of the first antenatal visit, and the number of antenatal visits attended. Information for the evaluation will be collected from antenatal cards, case files, hospital registers, medical records, interviews, and other study activities involving pregnant women and health providers. Researchers hope the findings will show whether a locally developed antenatal care improvement program can help prevent avoidable harm to mothers and babies and improve pregnancy care in a high-volume urban setting.

Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

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.

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy

This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes. Pregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role. Pregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations. The intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes. The aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.

LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

Preeclampsia is a major cause of maternal and perinatal morbidity and mortality worldwide. Low-dose aspirin started in the first trimester reduces the risk of preeclampsia in high-risk women. Low molecular weight heparin (LMWH) has shown potential benefits in addition to aspirin for preventing preeclampsia through its anticoagulant, anti-inflammatory, and endothelial protective effects. However, current evidence is limited and conflicting regarding the added value of LMWH to aspirin. This randomized controlled trial aims to evaluate the efficacy of combined aspirin and LMWH, compared to aspirin alone, for reducing the incidence of preeclampsia in high-risk gravidas.

Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines

To better understand postpartum blood pressure changes, the investigators are proposing a study to monitor blood pressure after delivery in 100 patients who the investigators expect to have normal blood pressure (i.e. low-risk group), 100 patients who the investigators expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who the investigators know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. The investigators expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.