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Eclampsia clinical trials

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NCT ID: NCT06377878 Recruiting - Preeclampsia Clinical Trials

The Preeclampsia Registry

TPR
Start date: September 1, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves.

NCT ID: NCT06340152 Recruiting - Pre-Eclampsia Clinical Trials

Multi-Omics for Maternal Health After Preeclampsia

MOM-Health
Start date: December 20, 2023
Phase:
Study type: Observational

To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.

NCT ID: NCT06330987 Recruiting - Pregnancy Related Clinical Trials

Fetal Autonomic Nervous sysTem Evaluation

FANTE
Start date: August 13, 2019
Phase:
Study type: Observational

The autonomic nervous system (ANS) is involved in cardiovascular, metabolic and cognitive processes, so its study in the fetus can provide relevant functional diagnostic and prognostic information. In particular, the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus. The goal of this open-label, non-randomized, prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation. The objetives are: - To Evaluate Fetal Autonomic Nervous System (FANTE) through the analysis of maternal electrocardiogram (ECG) and others clinical parameters usually used in pregnancy monitoring. - To identify any variations in the fetal ECG in the event of developmental or pathological maternal and/or fetal pregnancy. Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent.

NCT ID: NCT06322771 Recruiting - Pregnancy Related Clinical Trials

Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal

RANSPRE-refus
Start date: April 11, 2024
Phase:
Study type: Observational

The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

NCT ID: NCT06317467 Recruiting - Pre-Eclampsia Clinical Trials

Role of Anti-C1q Autoantibodies in Pregnancy

Start date: September 13, 2023
Phase:
Study type: Observational

Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE. C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy. Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear

NCT ID: NCT06261203 Recruiting - Pre-Eclampsia Clinical Trials

Low Dose Aspirin for Prevention of Early Pregnancy Loss

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide. The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries

NCT ID: NCT06219109 Recruiting - Eclampsia Clinical Trials

Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia

TiPER
Start date: May 8, 2023
Phase:
Study type: Observational

Patients with severe preeclampsia or eclampsia suffer from pulmonary complications. Accurate assessment of patients with pulmonary involvement using lung ultrasound (LUS) and echocardiography could lead to earlier detection of pre eclampsia and eclampsia associated pulmonary oedema, ARDS (acute respiratory distress syndrome) and other pulmonary complications. here is currently limited evidence regarding the features, severity, aetiology and history of pulmonary oedema in this group of patients Data from this prospective observational study will facilitate the early recognition of pre-eclamptic and eclamptic patients with pulmonary involvement to implement optimal triage and early therapeutic choices in a limited resource setting (diuretics, escalation to non invasive or invasive ventilation, referral to HDU (High dependency unit) or ICU, dialysis) and potentially reduce unfavorable outcomes.

NCT ID: NCT06180811 Recruiting - Obesity Clinical Trials

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women

Start date: January 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims: Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed Aim 2: To determine the prevalence of and change in social needs Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care

NCT ID: NCT06115122 Recruiting - Clinical trials for Cardiovascular Diseases

PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Start date: February 15, 2022
Phase:
Study type: Observational [Patient Registry]

The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome

NCT ID: NCT06108947 Recruiting - Pre-Eclampsia Clinical Trials

Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks

PEScreenNor
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Study population Around 3500 pregnant women attending a routine ultrasound scan at 11-14 weeks at St. Olavs hospital, Trondheim, Norway. Study period Dec 2023 - Jul 2025 Screening Patient history, blood pressure, uterine artery mean PI and PlGF will be plotted in the FMF algorithm for screening for preeclampsia in the first trimester. Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at the Center for Fetal Medicine in Trondheim. Placenta growth factor (PLGF) will be analyzed with Kryptor technology at Center for Laboratory Medicine, St. Olavs hospital. Prophylaxis Women with high risk for preterm preeclampsia (risk > 1:100) will be offered aspirin prophylaxis 150 mg x 1 from 11-14 weeks to 36 weeks. Women will be offered to participate in a randomized controlled trial (RCT). Study design and participants in the RCT A single center, open label, randomized, noninferiority trial conducted at St. Olavs hospital, Trondheim Norway from Dec 2023 to Jul 2025. The investigators will include around 300 women 18 years or older with a singleton live fetus, gestational age between 24 and 28 weeks, high risk of preterm preeclampsia (>1/100) in the first trimester screening, aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with a adherence of at least 50% and low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66). Randomization and masking Between 24 and 28 weeks of gestation, participants will be randomly designed, with a computer-based system in a 1:1 ratio, to continue aspirin (control group) or discontinue aspirin (intervention group). This is an open-label study without masking of patients or providers. Follow-up Both groups will have visits every 4 weeks between randomization and 36 weeks, and standard antenatal care after 37 weeks until delivery. Treatment adherence will be assessed by patient self-report and tablet count, and fetal growth and Doppler will be assessed at the scheduled visits between randomization and 36 weeks (at 24, 28, 32 and 36 weeks), and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have a telephone/video link follow-up 1-2 months after birth