Active clinical trials for "Pre-Eclampsia"

Magnesium has built up the reputation of a 'natural calcium antagonist'. However, the exact effect of magnesium on coagulation and more specifically on platelet function is still disputed. An important discrepancy between in vivo and in vitro studies exists. Magnesium has thus been reported to antagonize platelets in some studies, and to stimulate platelets in other studies. Current evidence seems to point in the direction of a general antagonization of aggregation and coagulation. Intravenous magnesium is often administered in pre-eclampsia as seizure prophylaxis. Therapeutic regimens usually consist of an intravenously administered loading dose (2-3 grams) and a maintenance infusion, targeting a plasma level of 2-3 mmol/L. Therapeutic drug monitoring is needed, as magnesium toxicity is an important concern.

BACKGROUND Preeclampsia is a major cause of maternal and neonatal morbidity worldwide. There is currently no cure for preeclampsia, the only definitive treatment is termination of pregnancy by induction of labour or caesarean section. Statin has been proposed to represent a new approach to improve disease outcome/prevent preeclampsia based on its multilayered activity toward pregnancy protection, including: protection of vascular endothelial cells survival, induce expression of heme oxygenase 1 (HO-1), inhibiting the release of soluble FMS-like tirosine kinase-1 (sFlt-1) and soluble endoglin (sEng), two main culprits in the pathophysiology of preeclampsia. OBJECTIVE The aim of this study is to observe the effect of pravastatin administration in patients with high risk of preeclampsia in order to reduce maternal and neonatal mortality and morbidity. METHODS This is a prospective randomized controlled clinical trial. The research will be held in 5 maternal fetal medicine centers in Indonesia (multicenter study). The recruitment will be done by permuted block random sampling methods, with sample size around 280 patients divides into two group. Patients with high risk of preeclampsia will be randomized either to get pravastatin 2 x 20 mg per oral and aspirin 1 x 80 mg (treatment group) or low dose aspirin only (control group). The patient will be followed regularly until delivery to obtain detailed maternal and neonatal outcome. OUTCOME Primary Outcomes: Maternal preeclampsia, severe preeclampsia, gestational hypertension, indicated preterm delivery less than 37 weeks, indicated preterm delivery less than 34 weeks, maternal complications, length of hospital stay, and any serious adverse event. Secondary Outcomes: Composite fetal/neonatal mortality and morbidity (stillbirth, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, intra uterine growth restriction [Small for Gestational Age (SGA) < 5th centile], and necrotizing enterocolitis), birthweight, birthweight percentile, level of care (well baby, intermediate, NICU), NICU length of stay, ventilator usage, and length of perinatal hospital stay. KEYWORDS: pravastatin, preeclampsia, neonatal mortality, neonatal morbidity

Background: Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences. Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management. Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible. Objectives: To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure. To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy. Methods: The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy. Outcome measures/variables: Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc. Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy Serious adverse events

It had been shown that high percentage of severe preeclampsia patients got a high cerebral perfusion pressure (CPP) due to abnormal autoregulation of cerebral blood vessels with associated endothelial dysfunction and disrupted blood brain barrier. Moreover, patients with high CPP is more likely to present with headache compared to other patients with normal CPP.In this particular scenario, use of magnesium sulphate is associated with marked reduction of CPP and. hence prevention of cerebral damage.This hypothesis was confirmed by new magnetic resonance techniques that demonstrated brain edema in eclampsia/ severe preeclampsia patient mostly due to vasogenic edema and less commonly attributed to cytotoxic edema. Changes in the optic nerve sheath diameter (ONSD) mirrors the changes in the Intracranial pressure(ICP), subsequently when the intracranial pressure increases the optic nerve sheath diameter (ONDS) also increases. The aim of this study is to determine the effect Magnesium sulphate infusion on intracranial pressure, in patients presented with severe preeclampsia by measuring changes in the ONSD using ultrasound examination.

The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of gestation.

The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate the blood and oxygen flow to the placenta using advanced U/S and MRI testing.

Background: Preeclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide, and it affects 3% to 8% of all pregnancies. Maternal and perinatal morbidity and mortality resulting from preeclampsia are due to its complications. Clinical prediction of complications associated with preeclampsia may facilitate initiation of timely management to reduce or avert adverse outcomes associated with the condition. Studies on current biomarkers (proteinuria or uric acid) have shown poor performance in the prediction of adverse pregnancy outcomes in preeclamptic women. Placental growth factor (PlGF) is an angiogenic growth factor that is exclusively produced by the trophoblast. Circulating levels of placental growth factor have been reported to be reduced in women with preeclampsia. Therefore there is a need to evaluate the predictive performance on adverse pregnancy outcomes of this pregnancy specific biomaker among preeclamptic women. Aim: To determine the predictive accuracy of maternal serum PlGF level for adverse pregnancy outcomes in preeclamptic women. Materials and Method: It is a prospective cohort study that will be conducted on 110 women that will be admitted for preeclampsia in the Federal Teaching Hospital and Saint Patrick Mile 4 Hospital Abakaliki. On admission women who will give informed consent will have their blood sample collected. The sample will be analysed using Enzyme linked Immunosorbent Assay technique to determine the level of PlGF (pg/ml). All the study participants will be followed up until delivery. The socio-demographic characteristics and maternal and perinatal adverse outcomes will be entered into a proforma. Data will be entered and analyzed using SPSS version 22.0. Strength and limitation: The strength of the study is that a single biomaker, PlGF, will be assayed and the test will be performed once, which is cost-saving. The limitation of this study is that there would not be long term follow up of participants after hospital discharge and so complications that will occur after discharge will not be assessed. Conclusion: Considering the contribution of preeclampsia to maternal morbidity and mortality in Abakaliki and poor predictive performance of available biochemical markers on adverse pregnancy outcomes among preeclamptic women, there is need to conduct this study so as to ascertain the utility of PlGF in predicting adverse outcome among preeclamptic women in Abakaliki.

Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of preeclampsia is unknown. Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most likely to be involved. More than 100 clinical, biophysical, and biochemical tests have been recommended to predict or identify the patient at risk for the future development of the disease. The results of the pooled data for the various tests and the lack of agreement between serial tests suggest that none of these clinical tests is sufficiently reliable for use as a screening test in clinical practice. As a result there is obviously a great need to develop a novel technology for the early detection of this pregnancy complication before its clinical manifestations appear. An early detection can help in early treatment to prevent or at least minimize the sequel of this disease. The aim of this project is the early detection of "Preeclampsia" and other pregnancy complications using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple and inexpensive toll termed NA-NOSE. Phase-I: The primary phase of this project is the comparison between volatile biomarkers' patterns of pregnant women suffering from "Preeclampsia", pregnant women that are considered to have "Normal Pregnancy", and healthy "Non-Pregnant" women. Phase-II: The secondary phase of this project is the ability to predict "Preeclampsia", as compared, head-to-head, with other potential predictors used in the current clinical practice.

The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.

Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases and 62 controls were enrolled into the study. The study was approved by the local ethics committee and all participants gave written consent.