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Preeclampsia clinical trials

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NCT ID: NCT04998942 Active, not recruiting - Preeclampsia Clinical Trials

Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

Start date: August 11, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04990141 Active, not recruiting - Preeclampsia Clinical Trials

Molecular Screening Method for Preeclampsia (PREMOM)

PREMOM
Start date: September 23, 2021
Phase:
Study type: Observational

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 has been evidenced and new technical approaches developed to detect circulating biomolecules in blood such as RNA fragments. The main objective of this study is to evaluate the diagnostic precision of the molecular profile from the maternal blood analysed for the early screening of early onset preeclampsia (EOPE).

NCT ID: NCT04974892 Active, not recruiting - Pregnancy Clinical Trials

Aspirin and Neutrophils in Preeclampsia

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The exact mechanisms by which aspirin prevents the development of preeclampsia in high-risk patients are currently not fully known. Furthermore, a small proportion of high-risk patients who are on low-dose aspirin (LDA) still go on to develop preeclampsia (PE). This longitudinal observational study will assess the immune profile in participants who are taking low dose aspirin (LDA) in pregnancy. As part of routine care, patients at high risk of developing preeclampsia are treated with LDA from 16 weeks gestation. The study will be conducted at Barts Health National Health Service (NHS) Trust. The study population will comprise of 2 groups of participants: 1. Those who respond to LDA and do not develop preeclampsia (responders) 2. Participants who do not respond to LDA and develop preeclampsia (non responders) Participants will be consented at their booking appointment. Participants will be eligible if they have a singleton pregnancy and are aged over 18 years. They will have an additional blood sample taken at 12, 20, 28 and 36 weeks gestation. The blood samples will be tested to assess immune cell function, metabolism and genetics. This will identify cumulative changes in immunobiology at key time points in pregnancy.

NCT ID: NCT04958057 Recruiting - Preeclampsia Clinical Trials

Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)

SAIL
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.

NCT ID: NCT04940260 Completed - Preeclampsia Clinical Trials

Soluble Factors and Renal Outcome in Preeclampsia

Start date: October 1, 2019
Phase:
Study type: Observational

Preeclampsia (PE) is an important complication of pregnancy and can lead to chronic kidney disease by causing endothelial damage and podocyte loss, Soluble forms-like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF), sFlt1 / PlGF ratio and endoglin are the biomarkers for the differential diagnosis of preeclampsia and other diseases. We aim to explore the correlation of these biomarkers with long term renal function, blood pressure and urine albumin creatinine ratio (UACR) in PE patients.

NCT ID: NCT04915794 Completed - Preeclampsia Clinical Trials

Preeclamptic Pregnancy Care Education

Start date: July 10, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of simulation training in nurses and midwives on knowledge and self-efficacy regarding preeclamptic pregnancy care. It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. The interests and needs in these environments are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and supported with feedback. Preeclampsia is clinically defined as a blood pressure of 140/90 mmHg or above after the 20th week of pregnancy and the addition of proteinuria (300mg / 24 hours). It can develop in about 5-10% of all pregnancies. It is defined as a nulliparous disease since it is seen in approximately 85% of women during their first pregnancy. Preeclampsia constitutes 15% of the causes of maternal mortality in our country. In studies evaluating the effectiveness of simulation training in planning the follow-up and care of preeclampsia, it was determined that this method increases the knowledge and self-confidence of nurses. For example; Christian and Krumwiede's study they found that the self-efficacy rates were significantly higher in the post-simulation test. In his study, Olubumno investigated the importance of simulation in increasing the critical thinking of perinatology nurses in the care of preeclamptic pregnant women, he found that the pre-test and post-test scores increased by 0.75 points, and this difference between the scores is statistically significant. Tabatabaeian et al., In their study comparing the effects of simulation-based education, coeducation and theoretical education on the performance of midwives in preeclampsia and eclampsia, found that the mean of the simulation group was higher than the other two groups. Preeclampsia is an important obstetric emergency in women's health and disease nursing. Thus, when they start working in the clinic, it is aimed to be able to suspect preeclampsia with the anamnesis they received from the pregnant who applied to them, and to gain them with the simulation method what they should pay attention to and how to do in the follow-up of the pregnant woman hospitalized with the diagnosis of preeclampsia. Studies conducted in our country did not include studies involving students and healthcare professionals in the management of preeclampsia with simulation methods. Therefore, it is aimed to contribute to the literature with this study.

NCT ID: NCT04914819 Completed - Weight Loss Clinical Trials

Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

EMPOWER-Mom
Start date: June 18, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04855513 Not yet recruiting - Preeclampsia Clinical Trials

Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial

PREMET
Start date: March 24, 2022
Phase: N/A
Study type: Interventional

This is an open label, randomized control trial (RCT) in which high risk for pre-eclampsia pregnant subjects will be randomly assigned to either an intervention group (metformin 1 gm twice daily plus aspirin 100 mg per day and standard of care) versus control group (aspirin 100 mg per day and standard of care) that will be administered between 11 to 13 weeks of gestation until delivery . Only women at high risk of pre-eclampsia as defined by the ACOG practice bulletin will be included (see inclusion criteria). Patient assignment will not be blinded as control group will not be given a placebo; the data will be analyzed on an intention to treat basis. Enrolled subjects will be followed throughout pregnancy and up to 30 days post-delivery (as per hospital practice).

NCT ID: NCT04846686 Completed - Preeclampsia Clinical Trials

Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

PRE-EVE
Start date: June 1, 2022
Phase:
Study type: Observational

The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors. A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.

NCT ID: NCT04825145 Completed - Preeclampsia Clinical Trials

Preeclampsia and Contact Activation

Start date: January 20, 2020
Phase:
Study type: Observational

Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome. PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis. Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE. The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.