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Eclampsia clinical trials

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NCT ID: NCT04908982 Recruiting - Pre-Eclampsia Clinical Trials

Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension

Start date: May 28, 2021
Phase: Phase 4
Study type: Interventional

In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.

NCT ID: NCT04877119 Recruiting - Clinical trials for Gestational Diabetes

sFlt-1:PlGF Ratio in Gestational Diabetes: PREDICTION (PREeclampsia in DIabetiC gestaTION) Study

PREDICTION
Start date: October 14, 2019
Phase:
Study type: Observational [Patient Registry]

The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia and can be used to predict the preeclampsia. However, its predictive value in pregnancy complicated by gestational diabetes is unclear. This study purposes are to validate a ratio of serum sFlt-1 to PlGF that would be predictive of the absence or presence of preeclampsia in the short term in women with singleton pregnancies complicated by diabetes in whom preeclampsia was suspected, and to evaluate the relationship among sFlt-1 to PlGF and placental histopathological alterations.

NCT ID: NCT04833881 Recruiting - Mechanism Clinical Trials

Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers

Start date: April 2021
Phase:
Study type: Observational

Pregnancy-induced hypertension is a unique abnormal blood pressure disease in women during pregnancy, including eclampsia, preeclampsia, pregnancy-induced hypertension, chronic hypertension and so on. Eclampsia can lead to convulsions, proteinuria, multiple organ failure, and eventually death. It is a very serious disease in women, and the incidence of pregnancy-induced hypertension during pregnancy is between 4% and 10%. The incidence of eclampsia ranges from 2% to 5%. Studies have shown that there are about 60,000 cases of stillbirth or stillbirth due to eclampsia every year worldwide. At present, there are many theories about the pathogenesis of eclampsia, such as oxidative stress theory, maternal and fetal interaction theory, immune imbalance theory, heredity theory and so on.

NCT ID: NCT04783597 Recruiting - Pre-Eclampsia Clinical Trials

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies

PULSE
Start date: July 12, 2021
Phase:
Study type: Observational

Despite advances in obstetric care, preeclampsia (PE) remains the leading cause of maternal death and disability in both developed and developing countries, contributing to over 70,000 maternal and 500,000 fetal deaths annually worldwide. PULSE was designed using a preventative medicine approach, focusing on improving early detection of PE as opposed to managing symptoms after onset. The study aims to uncover the earliest possible signs of PE using a combination of novel clinical tools and established diagnostic techniques to better identify, track, and manage high risk pregnant women. Specifically, PULSE will be examining the incorporation of a non-invasive test for the measurement of arterial stiffness, which has been shown to be predictive of hypertensive disorders. This test, in combination with a wide range of blood biomarkers, detailed ultrasound imaging, and a comprehensive battery of physical and mental health questionnaires, represents the largest, most comprehensive preventative PE study to date. The results of this work has the potential to revolutionize the way PE and other hypertensive disorders of pregnancy are managed and treated and can serve to inform the design of future preventative clinical research studies.

NCT ID: NCT04777097 Recruiting - Blood Loss Clinical Trials

Blood Loss and Preeclampsia

Start date: January 1, 2021
Phase:
Study type: Observational

Study of blood loss in preeclamptic patients using mathematical formulae

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: 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).