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Pre-eclampsia clinical trials

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NCT ID: NCT04766866 Recruiting - Preeclampsia Clinical Trials

sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.

PE37
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

- Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. - Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. - Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. - Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. - Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. - The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. - The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. - If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

NCT ID: NCT04731012 Recruiting - Preeclampsia Clinical Trials

Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies

Start date: January 1, 2020
Phase:
Study type: Observational

The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.

NCT ID: NCT04720690 Recruiting - Pre-Eclampsia Clinical Trials

Bioimpedence and Arterial Function Monitoring at Birth and in Infants

BAMBI
Start date: December 1, 2020
Phase:
Study type: Observational

Babies may be born appropriately grown for gestational age (AGA, >10th centile) or small for gestational age (SGA, <10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be <32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.

NCT ID: NCT04716244 Recruiting - Clinical trials for Gestational Diabetes

Development of Intervention for Women After Gestational Diabetes or Pre-eclampsia

Start date: January 20, 2021
Phase:
Study type: Observational

Our objectives in this qualitative exploratory study: - To explore the perspectives and preferences of women with preeclampsia and/or GDM history related to a potential health promotion program - To identify perception of support services post-birth related to health behaviors - To identify perception of personal and children's risk of future health issues related to GDM and preeclampsia history - To explore effective intervention strategies and approaches for potential intervention - To identify barriers and facilitators to adoption and adherence to healthy lifestyles changes in women with preeclampsia and/or GDM history - Based on our results, literature review and counselling by a panel of health promotion experts, the investigators will design protocol and guidelines for a future interventional health promotion programs Methods: Study Design The proposed study consists of a qualitative exploratory study in different populations of women who underwent gestational diabetes or pre-eclampsia. Health care providers who provide care to women with gestational diabetes and pre-eclampsia will be interviewed to explore effective intervention strategies.

NCT ID: NCT04676295 Recruiting - Clinical trials for Cardiovascular Diseases

Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health

FINNCARE
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Background: PE (pre-eclampsia) is a common pregnancy-specific vascular hypertensive disease affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their offspring long-term. PE provides a unique window for early risk profiling and CVD prevention. However, the efficacy of a family oriented lifestyle intervention to lower CVD risk in families with history of PE has not previously been evaluated. Aim: This study will explore the impact of PE on CVD progression 8-12 years from delivery in mothers and their children, and assess whether a lifestyle intervention is useful for lowering mother and child blood pressure and improving the CVD risk profile overall in families with a history of PE. Hypothesis: PE is related with CVD progression mediated by elevated blood pressure. Blood pressure and the CVD risk profile overall is modifiable in mothers and children by a 12-month behavioral lifestyle intervention in families with a history of PE. Study design: Randomized controlled behavioral lifestyle intervention trial where families (mother, child and father from the FINNPEC study) are offered the opportunity to participate in a lifestyle intervention program 8-12 years after a PE pregnancy. 300 PE families will be randomized 1:1 to a 12-month lifestyle intervention program or to a control group. A parallel group of 100 non-PE control families will be assessed at baseline and follow-up. Main outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child. Significance: This study will provide information on CVD progression in mothers and children 8-12 years from a PE pregnancy. Furthermore, the study assess the effect of a 12-month lifestyle intervention on blood pressure and CVD risk profile overall following a PE pregnancy. Potentially, the study provides the opportunity to identify PE families at highest risk of CVD progression and families amenable to blood pressure and CVD risk profile improvement.

NCT ID: NCT04632589 Recruiting - Clinical trials for Preeclampsia Postpartum

Losartan for Improved Vascular Endothelial Function After Preeclampsia

LIVE-PE
Start date: November 22, 2020
Phase: Early Phase 1
Study type: Interventional

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women. In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.

NCT ID: NCT04604535 Recruiting - Pre-Eclampsia Clinical Trials

The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy

Start date: October 22, 2020
Phase: N/A
Study type: Interventional

This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy

NCT ID: NCT04551807 Recruiting - Pregnancy Related Clinical Trials

Natural Versus Programmed Frozen Embryo Transfer (NatPro)

NatPro
Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).

NCT ID: NCT04520048 Recruiting - Pre-eclampsia Clinical Trials

Vascular Biomarkers Predictive of the Progression From Gestational Hypertension to Preeclampsia in Pregnant Women

BIOVASC-PreHTA
Start date: August 11, 2023
Phase: N/A
Study type: Interventional

Hypertension during pregnancy remains a leading cause of maternal and foetal morbidity and mortality. The frequency (5 to 10% of pregnancies) and potential severity of these diseases, both for the mother and the child, are reasons for standardizing and optimizing medical practices. The cause of hypertension during pregnancy and in particular the pathophysiology of preeclampsia remains poorly understood. Guidelines distinguish these two entities by the existence of proteinuria from and after the 20th week of amenorrhea and by maternal-foetal complications, more serious in pre-eclampsia than in gestational hypertension. During gestational hypertension and preeclampsia acute placental vasculature and blood flow abnormalities were observed, maybe due to generalized vascular endothelial activation and vasospasm resulting in systemic hypertension and organ hypoperfusion. Endothelial dysfunction and abnormal expression of several specific blood biomarkers are now well accepted as characteristics of preeclampsia. However, the progression of gestational hypertension to preeclampsia is difficult to predict; between 15 and 40 % of gestational hypertension cases progress to preeclampsia, suggesting that it is the same worsening disease. Endothelial dysfunction could be at the origin of gestational hypertension, and subsequent development of preeclampsia through an imbalance between pro- and anti-angiogenic factors. The main objective of this research is to assess whether the alteration of endothelium-dependent vasodilatation in pregnant women with stable hypertension is correlated with the occurrence of preeclampsia later during pregnancy.

NCT ID: NCT04508582 Recruiting - Hypertension Clinical Trials

Cardiac and Immune Cell Function in Preeclampsia

Start date: November 25, 2020
Phase:
Study type: Observational [Patient Registry]

Preeclampsia is a multi-system vascular disease which affects 2-5% of pregnancies. It is also a risk factor for the development of cardiovascular disease later in life and a number of functional and structural cardiac changes have been found in this population of patients. In mouse models disruption of a group of immune cells, neutrophils, has led to alteration of the placenta and offspring consistent with those seen in preeclampsia. These mice also have an abnormal cardiac function and structure (Nadkarni et al 2016). The investigators hypothesis that this may also occur in humans. This study aims to intimately link the maternal immunological and vascular components of cardiac dysfunction in women preeclampsia. The investigators hypothesise that in preeclampsia activated neutrophils may affect maternal immune system thus leading to myocardial injury and altered cardiac function. The study intends to identify the mechanisms by which the maternal immune system (focusing on neutrophil and T-cell subsets) affects cardiac function in women with preeclampsia. Specific aims to be addressed are: Aim 1: To correlate specific neutrophil phenotype(s) and function to cardiac function in women with preeclampsia during pregnancy Aim 2: To test whether specific activated neutrophil phenotype persists postpartum and whether this neutrophil phenotype correlates with cardiac function in women with preeclampsia postpartum The study population will comprise of 3 groups: 1. Normotensive pregnant (~33 patients) 2. Pregnancy-induced hypertension (PIH; New-onset hypertension after 20 weeks without proteinuria; ~33 patients) 3. Preeclampsia (~34 patients) Cardiac function will be evaluated using cardiovascular magnetic resonance, echocardiography and cardiac markers in the blood. The participants immune system will be assessed from blood samples looking at the immune cells, hormone levels and inflammatory and non-inflammatory mediators. The secondary research objective is to investigate whether changes in the immune system and cardiac function in participants is persistent after delivery. Therefore participants will have scans and blood tests both antenatally and at 3 months postnatally. By identifying key changes in immune cell type and function with cardiac abnormalities in women with preeclampsia, data obtained from this study could provide novel insight into how the maternal immune system influences cardiac changes in normal and preeclamptic pregnancies. Identifying such links could pave the way for future therapeutic targets.