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Pre-eclampsia clinical trials

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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

NCT ID: NCT06100484 Recruiting - Preeclampsia Clinical Trials

Blood Pressure Variability Effect on Right Ventricular Strain in Women With Hypertensive Disorders With Pregnancy

Start date: October 6, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the potential effect of blood pressure variability changes on right ventricular strain in pregnant women with gestational hypertension or pre-eclampsia

NCT ID: NCT06099275 Recruiting - Preeclampsia Clinical Trials

Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography

Start date: October 25, 2023
Phase:
Study type: Observational

The goal of this observational trial is to determine the resting cardiac output (CO) using transthoracic echocardiography (TTE) in a cohort of people with untreated preeclampsia, and a cohort of healthy normotensive pregnant people.

NCT ID: NCT06069102 Recruiting - Hypertension Clinical Trials

Optimal Blood Pressure Treatment Thresholds Postpartum

Start date: November 15, 2023
Phase: Phase 4
Study type: Interventional

The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

NCT ID: NCT06067906 Recruiting - Obesity Clinical Trials

Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients

POPADIPE
Start date: September 14, 2023
Phase: N/A
Study type: Interventional

In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass. The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.

NCT ID: NCT06066411 Recruiting - Preeclampsia Clinical Trials

The Effect of Massage Ball Application on Blood Pressure, Fatigue and Anxiety in Pregnant With Preeclampsia

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of massage ball application on arterial blood pressure, fatigue and anxiety in pregnant women diagnosed with preeclampsia.

NCT ID: NCT06065709 Recruiting - Preeclampsia Clinical Trials

Mindfulness Breath Awareness Meditation and Preeclampsia

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

The effect of mindfulness breath awareness meditation on health profile, vital signs, and fetal heart rate in pregnant women with preeclampsia

NCT ID: NCT06033131 Recruiting - Preeclampsia Clinical Trials

PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia

PI4
Start date: January 19, 2024
Phase: Phase 3
Study type: Interventional

Preterm preeclampsia is a severe condition for both the mother and the fetus. Currently, the only treatment available to stop disease progression is termination/delivery of the fetus and placenta. Therefore, preterm preeclampsia carries the highest rates of neonatal morbidity and mortality due to iatrogenic preterm birth. There is evidence suggesting metformin, a drug commonly used to treat diabetes in and outside pregnancy, may be able to counter the pathophysiology of preeclampsia, raising the possibility that it could be used to treat the condition. This multi centre double blind randomised controlled trial aims to investigate if metformin can prolong gestation, lower neonatal length of stay and increase birthweight in a Swedish setting.

NCT ID: NCT06002971 Recruiting - Pregnancy Related Clinical Trials

CONNEQT Pulse Validation Study

Start date: August 21, 2023
Phase:
Study type: Observational

The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.

NCT ID: NCT05995106 Recruiting - Preeclampsia Clinical Trials

mHealth for Hypertensive Disorder of Pregnancy

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Objectives: We have developed a cardiovascular disease management application named Heart4U, with the capability of integrating with the Electronic Medical Records (EMR) system within the hospital. The main goal of this study is to evaluate the clinical effectiveness of a treatment approach that entails self-management of risk factors through a mobile application among pregnant individuals diagnosed with hypertensive cardiovascular conditions. Methods: Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage. Both the app group and the usual care group continue to receive active treatment as previously administered (guideline-based prenatal care). Follow-up observations occur at each obstetric examination prior to delivery and are conducted again at the first month postpartum. The primary endpoint of observation pertains to the difference in systolic blood pressure between the enrollment and study completion time points.