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Showing 1-20 of 29 trials
NCT05473767
This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on postpartum mothers and infants. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.
NCT07298759
The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation. Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.
NCT05049616
The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.
NCT07115199
We hypothesize that frequent remote monitoring of blood pressure and real-time antihypertensive medication titration will optimize pregnancy outcomes in a clinically meaningful and cost-effective manner compared to the current standard of care. Therefore, this pilot study, as part of the K12 training support, will evaluate the feasibility of a randomized clinical trial to treat mild chronic hypertension with medication therapy to a blood pressure goal of less than 140/90 mmHg based on remote daily patient monitoring compared to in-office blood pressure readings.
NCT04626245
Hypertensive disorders of pregnancy (HDP) are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the Unites States. HDP also increase lifetime cardiac disease risk in women and infants. Current interventions to prevent HDP are limited, and interventions that do not include medications are minimally effective at preventing HDP. Mindfulness interventions hold promise as a intervention to prevent HDP that does not require pregnant women to take medications. Past research shows that mindfulness interventions reduce blood pressure in adults with hypertension and pre-hypertension. However, past studies of mindfulness interventions for pregnant women have not allowed women at risk for HDP to participate. The preliminary study of prenatal mindfulness training for women at risk for HDP demonstrated benefit on maternal blood pressure and fetal growth. However, the mechanisms explaining effects of prenatal mindfulness training on risk for HDP are unknown. Building upon these promising preliminary findings, the proposed clinical trial will measure daily experiences of stress, physiological reactivity to stress, and interpersonal processes before and after prenatal mindfulness training. The investigators hypothesize that mindfulness training will impact these processes, which may lead to improved maternal cardiovascular parameters and reduced risk for HDP. N=150 pregnant women at risk for HDP will be randomized to an 8-week phone-delivered mindfulness intervention or usual care. For every participant, we will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the 8-week period. All participants will complete surveys of daily experiences for 2 weeks before and after the 8-week period to evaluate mechanisms of mindfulness training on maternal cardiovascular parameters. Daily experiences will be measured using surveys delivered via smartphone-app, ambient audio sampling, and wearable wrist-worn biosensor monitoring (heart rate and heart rate variability).
NCT05852054
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
NCT06773299
The purpose of the ENHANCE-CVH study is to promote intergenerational cardiovascular health (CVH) of women and children in Abuja and the surrounding Federal Capital Territory of Nigeria. The study team plans to achieve this through an adaptation of an existing evidence based intervention - Parents as Teachers (PAT) curriculum + Healthy Eating Active Living Taught at Home (HEALTH) - among pregnant women with obesity and their children in Nigeria. The aim of the study is to evaluate the effectiveness and implementation of community health educator-led delivery of the PAT+HEALTH intervention via home visits to answer the following main questions: * Will the women participating in the intervention have a greater change in weight from baseline to 18-month follow up compared to the women who do not? * Will the women and children in the intervention group display better CVH promoting lifestyle behaviors compared to those in the control group? Participants in the study will complete baseline surveys and have clinical data, lab data, and body measurements captured. Participants will also have these procedures repeated at birth and every 6 months up to 24 months post-delivery. Once randomized to the intervention group, participants will complete 40 biweekly PAT+HEALTH curriculum delivery sessions, each lasting approximately 60-90 minutes.
NCT05793125
To correlate fetal Pulmonary artery Doppler parameters with neonatal outcome in patients diagnosed with hypertensive disorders of pregnancy.
NCT05155852
The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.
NCT05543265
Chronic health conditions affect most older adults. Preventative medicine and risk management strategies, especially when applied earlier in life, are essential to altering the trajectory of a disease and ultimately improving health outcomes. Primary care providers (PCP) often provide most of these services, though younger adults are the least likely to receive primary care. This project leverages a period of high engagement and health activation during an individual's life (pregnancy) to nudge her toward use of primary care after the pregnancy episode. This randomized controlled trial will test the hypothesis that a behavioral science-informed intervention, incorporating defaults and salience, can increase the rates of PCP follow-up within 4 months following a delivery for individual with hypertension, diabetes, obesity. If successful, this intervention could serve as a scalable solution to increase primary care use and preventative health services in a population that currently has low rates of engagement and utilization of these services.
NCT05673135
Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.
NCT05309460
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
NCT04914819
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
NCT04748107
The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.
NCT04998942
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.
NCT04349124
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.
NCT03595982
Antihypertensive therapy has been used in pregnant patients antepartum to improve blood pressure (BP) elevation in cases of chronic hypertension, and postpartum for persistent hypertension after delivery in cases of gestational hypertension and preeclampsia, as well as for management of chronic hypertension. There is limited evidence regarding the precise BP level at which antihypertensive therapy is indicated during pregnancy for chronic hypertension. Treatment has been suggested in pregnant patients when systolic BP is ≥ 160 mmHg and at a lower diastolic BP threshold of 105 mm Hg, however some providers may initiate therapy at systolic BPs ≥ 150 mmHg. Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile. It has been proven to be safe in pregnancy. Conventional nifedipine can be started at 10 mg twice daily with a maximum dose of 120 mg/d, but frequently extended release tablets are preferred due to steady blood pressure control with once daily administration. It is frequently used however as a twice daily dosing as many providers have noticed an increase in the BPs 12-24h from administration. Twice daily dosing might produce overlapping profiles that prevent elevation of BP at the time of the next administration and breakthrough elevations throughout the day in pregnant women. The aim of this study is to investigate the mean plasma levels and standard deviations of Procardia at 24h after Procardia XL is administered as a 60 mg daily dose and the mean plasma levels after it is given as a 30 mg twice-daily dose. This will be a pilot study for a future randomized control trial that will allow the researchers to determine whether 60 mg daily of Procardia XL is equivalent to 30 mg twice daily. Secondary outcome will be effective control of BP throughout the day (0h, 4h, 8h, 12h, 16h, 20h and 24h) defined as BPs below 160/105 as well as side effects of nifedipine as reported by patients.
NCT03873194
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.
NCT04924738
This prospective observational trial includes women with high risk pregnancies complicated with hyperglycemia in pregnancy and excessive body weight. The participants are enrolled when pregnant and monitored throughout pregnancy and delivery until the offspring is 6 months old. This research addresses the question which risk factors for non-communicable disorders such as hypertension, obesity, type 2 diabetes for a woman and her offspring can be detected during pregnancy and in early childhood.
NCT03506724
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.