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Pre-eclampsia clinical trials

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NCT ID: NCT06468202 Not yet recruiting - Preeclampsia Clinical Trials

Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

ASPIRIN
Start date: December 1, 2024
Phase: Phase 4
Study type: Interventional

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

NCT ID: NCT06464159 Not yet recruiting - Preeclampsia Clinical Trials

New Therapeutic Strategy Against Preeclampsia

APHERESE2
Start date: June 2024
Phase:
Study type: Observational

Preeclampsia is a hypertensive disorder of pregnancy associated with important maternal and perinatal mortality. It complicates 2 to 5% of pregnancies and causes more than 70 000 maternal deaths each year worldwide. Although symptomatic management has improved there is currently no curative treatment, and only childbirth and delivery of the placenta, usually prematurely, alleviate the mother's symptoms. The management of extremely preterm infants is a major societal challenge in medical, ethical and economic terms. Placental insufficiency plays a central role in the pathophysiology of preeclampsia. Abnormal placentation during the first trimester leads to placental hypoperfusion, which induces trophoblast dysfunction and the release in maternal circulation of trophoblastic factors leading to the maternal symptoms. Among molecules that participate to the pathophysiology of preeclampsia, one of the most important players is soluble fms-like tyrosine kinase 1 (sFlt-1), which is a soluble form of the vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF) receptor. sFlt-1 binds to free VEGF and PlGF in the maternal circulation, thus reducing their bioavailability for their membrane receptors. Targeting the sFlt-1 pathway is one of the most promising strategies for the development of new treatments for preeclampsia. As sFlt-1 results from alternative splicing, its peptide sequence is identical to that of the extracellular part of the membrane receptor. The development of drugs that act specifically on the soluble form and not on the membrane form is therefore particularly complex. The general objective of this research is to restore the angiogenic balance that maintains the physiological concentrations of free angiogenic factors in order to significantly prolong the pregnancy and diminish the consequences of the great prematurity. The precise objectives of the APHERESE 2 project are: 1. To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column 2. To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient

NCT ID: NCT06452498 Not yet recruiting - Pre-Eclampsia Clinical Trials

Preeclampsia Intervention Netherlands

PI-NL
Start date: August 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development. Metformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.

NCT ID: NCT06445543 Not yet recruiting - Clinical trials for Gestational Hypertension

Nutrition Optimization and Community Upliftment for Postpartum Recovery: Intervention to Support Healing After Hypertensive Disorders of Pregnancy

NOURISH-HDP
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent chronic hypertension-a potent contributor to disparate mortality among Black women. - To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, MFeast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only). - To test sustainability and scalability. Participants will: - Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3 and 6 months post-delivery after the baseline survey. - Submit anthropometric data (e.g. weight and blood pressure)

NCT ID: NCT06437535 Not yet recruiting - Pre-Eclampsia Clinical Trials

Role of Vaspin in Pathophysiology of Pre-eclampsia

Start date: June 2024
Phase:
Study type: Observational

- To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women . - To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women. - To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women . - To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women . - To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women . - Correlation between vaspin and apoptosis in pre-eclamptic obese women . - Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity).

NCT ID: NCT06430398 Recruiting - Preeclampsia Clinical Trials

A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy

PREMEM
Start date: March 1, 2023
Phase:
Study type: Observational

Preeclampsia (PE) is a leading cause of maternal-fetal morbidity and mortality, affecting 3-8% of pregnancies and causing over 76,000 maternal deaths annually. PE is characterized by high blood pressure and proteinuria or organ damage/intrauterine growth restriction (IUGR). There are two phenotypes: placental PE, caused by abnormal trophoblast invasion, often leading to early pregnancy complications and IUGR, and metabolic PE, associated with maternal metabolic issues like visceral obesity and metabolic syndrome, leading to low-grade inflammation and insulin resistance. Recent research highlights the role of maternal gut microbiota in these conditions, suggesting that gut dysbiosis-altered microbial balance-can influence systemic immune responses and contribute to PE. This study aims to characterize the maternal gut microbiota in the two PE phenotypes to better understand their distinct etiologies and improve prediction and prevention strategies.

NCT ID: NCT06421493 Recruiting - Preeclampsia Clinical Trials

Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders

MATER
Start date: June 6, 2020
Phase:
Study type: Observational

Preeclampsia (PE) is a significant cause of maternal and fetal morbidity and mortality, characterized by high blood pressure and proteinuria during pregnancy. It has two main phenotypes: one linked to placental damage and the other to metabolic factors like obesity. Early identification of high-risk groups is crucial, though there's ongoing disagreement over its classification. Research suggests a potential connection between maternal gut bacteria and PE, offering avenues for improved prevention strategies. This study aims to investigate the differences in maternal gut microbiota between these two PE phenotypes.

NCT ID: NCT06417411 Recruiting - Sickle Cell Disease Clinical Trials

LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

LEARNER
Start date: March 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period.

NCT ID: NCT06416995 Recruiting - Preterm Birth Clinical Trials

Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

Start date: March 3, 2023
Phase:
Study type: Observational

Investigation of the relationship between maternal serum vasohibin-1, vasohibin-2, cardiotrophin -1 and endocan concentrations at the 11th and 14th weeks of gestation and adverse perinatal outcomes.

NCT ID: NCT06414655 Recruiting - Pre-Eclampsia Clinical Trials

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China

ChiTwiMC
Start date: March 1, 2024
Phase:
Study type: Observational

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.