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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: NCT06387784 Not yet recruiting - Pre-Eclampsia Clinical Trials

Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies

BEET_PE
Start date: June 2024
Phase: N/A
Study type: Interventional

Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia.

NCT ID: NCT06385600 Not yet recruiting - Clinical trials for Severe Pre-eclampsia

Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.

Start date: May 20, 2024
Phase: N/A
Study type: Interventional

The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension

NCT ID: NCT06385366 Not yet recruiting - Preterm Birth Clinical Trials

Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test

Start date: May 15, 2024
Phase:
Study type: Observational

This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam.

NCT ID: NCT06373367 Not yet recruiting - Preeclampsia Clinical Trials

Preeclampsia Educational Program Study (PrEPS)

PrEPS
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.

NCT ID: NCT06353256 Not yet recruiting - Clinical trials for Preeclampsia Postpartum

A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

AW2H
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.