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Pre-eclampsia clinical trials

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NCT ID: NCT03831490 Completed - Pre-Eclampsia Clinical Trials

Study for Improving Maternal, Pregnancy and Child Outcomes

IMPACT
Start date: November 9, 2018
Phase:
Study type: Observational [Patient Registry]

The overall aims of this proposal are to improve, facilitate, optimize and equalize the existing screening system for adverse pregnancy outcomes in early pregnancy in order to limit adverse consequences for both the mother and infant, by: 1. Creating a Swedish prediction model with population-specific risk factors, optimized for the Swedish health care system, identifying high-risk women for preterm preeclampsia and validate the model within the cohort. This would give us the possibility to start aspirin prophylaxis in time, which has been proven to reduce the risk of developing preterm preeclampsia by 50%. 2. Validating the Fetal Medicine Foundation prediction model for detection of preterm (< 37 gestational weeks) preeclampsia in a Swedish population. 3. Creating a prediction model identifying high-risk women for overall preeclampsia during pregnancy and birth of a small for gestational age infant in order to plan individualized surveillance for early detection, which has been proven beneficial for both the mother and infant. 4. Creating a national pregnancy biobank with blood samples and individual clinical registry data, including pregnancy outcomes, enabling future research on prevention and early detection for various adverse pregnancy outcomes which could be such as preterm birth and intrauterine growth restriction.

NCT ID: NCT03815110 Completed - Clinical trials for Gestational Hypertension

Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification

PRAECIS
Start date: December 20, 2018
Phase:
Study type: Observational

The purpose of this study is to 1. Identify a cut-off for the ratio of the serum proteins soluble FMS-like Tyrosine Kinase 1 (sFLT-1) and placental growth factor (PlGF) that identifies women will who develop preeclampsia with severe features within 2 weeks of testing (clinically positive) from those who do not develop preeclampsia with severe features within 2 weeks of testing (clinically negative) among preterm pregnant women with hypertensive disorders of pregnancy. And 2. To validate the cut-off the ratio of sFLT-1 and PlGF and to validate the performance of the automated assays used to find the cut-off. Test performance includes positive predictive value, negative predictive value, sensitivity, and specificity. Subjects will provide blood, urine, and saliva samples at the time of enrollment. Samples will be frozen for batch assessment of sFLT-1 and PlGF levels by automated assays. Clinicians, subjects, and researchers will be blinded to protein level assessment, therefore assay results will not affect clinical management.

NCT ID: NCT03801447 Completed - Preeclampsia Clinical Trials

Biomarkers and Preeclampsia Outcomes

REPORTS
Start date: April 1, 2018
Phase:
Study type: Observational

Prospective, observational, monocentric, non-interventional study.

NCT ID: NCT03755843 Completed - Pre-Eclampsia Clinical Trials

PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA

Start date: December 1, 2016
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: A cornerstone of treatment in preeclampsia is to correct the potential hypovolemia with intravascular optimisation, which is usually performed as a fluid challenge. The prediction of fluid responsiveness in these patients, secondary to anatomical and physiological changes associated with pregnancy has not been established. This study aims to evaluate if Passive Leg Raising (PLR) protocol can predict fluid responsiveness in pregnant patients with severe preeclampsia. MATERIALS AND METHODS: in 35 pregnant women diagnosed with preeclampsia with a clinical indication to optimise intravascular volume, . A PLR manoeuvre and a fluid challenge will be performed, and hemodynamic parameters were recorded using Bioreactance technology. Descriptive statistical analyses, Pearson chi-square test, and mean standard deviation (SD) will be calculated. Analysis of proportion was used to calculate probabilistic intersections of the interventions. The area under curve, sensitivity, specificity, positive predictive value and negative predictive value were calculated for a delta of 12. Objective: to evaluate the if passive leg rising protocol identifies fluid responsivness in pregnant patients with preeclampsia

NCT ID: NCT03750695 Completed - Obesity Clinical Trials

Acute Exercise Effects in Obese Pregnancy

Start date: November 20, 2018
Phase: N/A
Study type: Interventional

Obesity before and during pregnancy is associated with a higher risk for a number of obstetric and metabolic complications in women and their offspring. Of particular importance, obese women have a higher risk of developing gestational diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher risk for the development of obesity and diabetes; both largely attributed to higher maternal glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical and have immediate and generational impact. Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal, metabolic and cardiovascular health in non-gravid adolescents and adults with obesity however little is known regarding the effects of exercise during obese pregnancy. This study proposes to collect preliminary data on the independent effects of acute aerobic and resistance rehabilitative exercise on glucose metabolism and vascular function during pregnancy in n=15 obese women in order to inform a large, multisite clinical trial examining the acute and chronic effects of aerobic and resistance exercise on glucose metabolism and vascular function in normal weight, overweight and obese women during pregnancy.

NCT ID: NCT03749746 Completed - Obesity Clinical Trials

Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia

HH4NM
Start date: January 26, 2019
Phase: N/A
Study type: Interventional

Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high recurrence risk and a rapid, occult progression to cardiovascular disease after delivery. There is a critical need for effective interventions to reduce these risks. This is a pilot randomized controlled trial of a novel postpartum lifestyle intervention compared to women who take home blood pressure measurements and women with usual care who are overweight and obese in the first year after preeclampsia. The investigators hypothesize that the intervention will lead to improved weight loss and blood pressure in the first year postpartum, which has broad implications for future pregnancy and long-term cardiovascular health.

NCT ID: NCT03749044 Completed - Pre-Eclampsia Clinical Trials

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Start date: May 28, 2018
Phase: N/A
Study type: Interventional

Preeclampsia is a serious maternal condition affecting up to 5% of pregnancies from the general population and up to 30% of lupus pregnancies. Aspirin (acetylsalicylic acid- ASA) has been shown to reduce the risk of preeclampsia, by half, in women at high risk. Therefore, it is recommended that health professionals initiate aspirin early during pregnancy in women with lupus. Despite this recommendation, there are currently no studies of aspirin in women with lupus for this indication. This is a critical knowledge gap as aspirin could potentially have a large benefit in this high-risk population. The investigator will perform a RCT to evaluate the effect of a specifically designed patient educational tool on preeclampsia knowledge and ASA adherence in pregnant women with SLE. The research efforts will improve reproductive health of SLE women and the outcomes of offsprings.

NCT ID: NCT03741179 Completed - Pre-Eclampsia Clinical Trials

Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy

StopPRE
Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

Pregnant women at a higher risk for pre-eclampsia (PE) should be offered preventive daily treatment with acetylsalicylic acid (ASA) started before 16 weeks of gestation. To select patients at higher risk for PE, multiparametric assessment combining maternal history, biochemical factors and biophysical factors should be used during the first trimester of pregnancy. Multiparametric risk assessments have a detection rate for early-onset PE around 80% at a false positive rate of 10%. Owing to the low prevalence of early-onset and preterm PE, more than 90% of patients considered at high risk, at the first-trimester screening, will not eventually develop PE. Thus, ASA treatment would be innecessary and could be safely discontinued in these patients. The sFlt-1 to PlGF ratio has a high negative predictive value for PE during the second and third trimester of pregnancy. Thus, it could be used to detect false-positive patients from the first-trimester screening. This is a multicentric, randomized, open, parallel, controlled, phase III trial, where 1,080 patients under treatment with ASA for being at high risk for preeclampsia from the first-trimester screening, will be candidates to participate. Patients with a sFlt-1/PlGF <38, from 24 to 27+6 weeks of gestation will be randomized at a 1:1 ratio and allocated to either continue ASA until 36 weeks or to stop ASA treatment.

NCT ID: NCT03728790 Completed - Clinical trials for Hypertensive Disorder of Pregnancy

Remote BP Monitoring in the PP Period

Start date: November 9, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.

NCT ID: NCT03674606 Completed - Pre-Eclampsia Clinical Trials

Trial of Early Screening Test for Pre-eclampsia and Growth Restriction

TEST
Start date: February 1, 2014
Phase: Phase 4
Study type: Interventional

A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus