Active clinical trials for "Eclampsia"

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.

Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.

Hypertensive disorders of pregnancy (HDP) are stress tests which may identify women at high risk of future cardiovascular disease (CVD), the leading cause of death among women. Given the public health impact of HDP and CVD, there is a compelling need to identify scalable interventions to improve preventative care among women who have risk identified during pregnancy. We will examine the effects of delivering electronic prompts to obstetric care providers (nudge) on transitions of care in the postpartum period. We will conduct a pilot randomized trial to evaluate whether this nudge intervention will improve postpartum counseling and lead to greater follow-up with preventative care providers among women with HDP.

Due to the fetoneonatal pathway it is possible to identify pregnant women with an increased risk of fetal growth restriction or pre-eclampsia in early stages (from 10th week of pregnancy). Women whose pregnancy is considered high-risk receives risk-adapted prenatal treatment as well as certain treatments for their newborn and infant until 1 year of age. The tasks of all involved persons are defined by standard operating procedures (SOP)

A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.

FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

This study is a cross-sectional case-control study where classical as well as more innovative risk factors for CVD will be explored. In western countries, more women than men die of cardiovascular disease (CVD), making CVD in women an important public health issue. Misdiagnosis of CVD in women is frequently observed, posing the clinician for diagnostic and therapeutic dilemmas that can easily result in inadequate treatment and worse prognosis. Despite these challenges, CVD in women has been underexposed in scientific research. Women have gender-specific risk factors like a history of preeclampsia (PE) that contribute to their risk for CVD. PE complicates 5-10% of pregnancies, recurs in ~25% and is associated with a 2-4 fold increased risk for CVD. Moreover, pre-symptomatic heart failure (HF) stage B occurs in 40% of women with a history of PE. HF stage B is thought to precede the development of the, mortality related, clinical HF stages C and D (structural heart disease in combination with symptomatic disease). Early detection and tailored intervention of women with stage B HF decreases progression to the clinical stages and might therefore improve clinical outcome and cardiovascular related mortality. Phenotypic presentation of HF is currently split up between systolic HF also called HF with reduced ejection fraction (HFrEF) and diastolic HF or HF with preserved ejection fraction (HFpEF). Women more often have HFpEF in contrast to men. Different pathophysiology and disease progression in women compared to men seems to be an important underlying factor. The current clinical HF diagnostic tools (e.g. natriuretic hormones and high sensitivity troponins) fail to identify early changes that prelude adverse cardiac remodelling and HF, and do not discriminate between HFrEF and HFpEF. Moreover, there are sex-related differences in biomarker levels for detection of CVD. As a result, clinicians are forced to wait for the failing heart to become clinically evident before they can intervene. Therefore, there is an urgent need to assess novel biomarkers that could help select high risk women needing further follow up and intervention. Biomarkers may not only improve early diagnosis but may also unravel disease pathways of HFpEF. Especially when combined with measurements of subclinical, surrogate risk markers. Objectives To determine the impact of PE on incidence of macro-and micro-vascular dysfunction reflected by surrogate measures for coronary artery disease (CAD) and HFpEF. To perform a genome wide association study (GWAS) and associate novel biomarker expression levels with endothelial function, cardiac diastolic function and IMT measurement. To identify risk factors and surrogate measures for CVD in a) former PE patients without HFpEF, b) former PE patients with HFpEF and c) healthy parous controls. Study population Cases: women with a history of PE Controls: women with uncomplicated pregnancies in the history. Measurements will be performed in clusters at postpartum intervals of: ½-2, 5-10, 10-15 and 15-30 years. Number of inclusions will be: 425, 350, 282 and 233 for each follow-up group respectively. Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE patients. Novel biomarker detection in former PE patients associated with HF in general and HFpEF in particular. Secondary endpoints Lifestyle (questionnaire) Cognitive ability (questionnaire) Depression score (questionnaire) Metabolic syndrome (MetS) Arterial endothelial function (Flow mediated dilation (FMD)) Intima Media Thickness (IMT) Glycocalyx thickness (by means of the Glycocheck) Venous function (plethysmograph) Electrocardiogram (ECG) Ergometry

This is an open label, randomized control trial (RCT) in which high risk for pre-eclampsia pregnant subjects will be randomly assigned to either an intervention group (metformin 1 gm twice daily plus aspirin 100 mg per day and standard of care) versus control group (aspirin 100 mg per day and standard of care) that will be administered between 11 to 13 weeks of gestation until delivery . Only women at high risk of pre-eclampsia as defined by the ACOG practice bulletin will be included (see inclusion criteria). Patient assignment will not be blinded as control group will not be given a placebo; the data will be analyzed on an intention to treat basis. Enrolled subjects will be followed throughout pregnancy and up to 30 days post-delivery (as per hospital practice).

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Primary Outcome:- GDM Diagnosis Secondary Outcomes:- Pre-eclampsia diagnosis. Cesarean section delivery due to labor dystocia defined as protracted or arrested progress of labor using labor partogram.