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Pre-eclampsia clinical trials

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NCT ID: NCT03441711 Completed - Preeclampsia Clinical Trials

sFlt-1:PlGF Ratio in Diagnosing Superimposed Preeclampsia

Start date: February 2016
Phase:
Study type: Observational

Preeclampsia: associated with poor placentation, incomplete uteroplacental spiral arteries remodeling. Result: ischemia, re-perfusion injury, oxidative stress. A low-grade systemic inflammatory response is more pronounced in preeclampsia. This results in an imbalance between maternal circulating pro-angiogenic (PlGF & VEGF) & anti-angiogenic factors (sFlt-1). PlGF & VEGF function as vasodilators & preserve structure & function of glomerular endothelium. sFlt-1 blocks these actions, resulting in hypertension, endothelial dysfunction & nephropathy. Various stressors, including hypoxia, villous crowding, angiotensin II, & oxidative stress are associated with preeclampsia & mediate secretion of soluble vascular growth factor 1 (sVEGFR-1 or sFlt-1) by GADD45 (Growth Arrest and DNA Damage-45). GADD45 is one of a family of stress-induced genes sFlt-1 releases into maternal circulation. Excess sFlt-1 leads to endothelial dysfunction, hypertension & proteinuria. Exogenously administered sFlt-1 results in syndrome of nephrotic range proteinuria, hypertension, and glomerular endotheliosis in animal models. Women with preeclampsia tend to have higher sFlt-1 & lower PlGF, resulting in an increased ratio (sFlt-1:PlGF). The difference is greater in women who develop early-onset preeclampsia (before 34 wks gestation). Verlohren, et al., showed an increased sFlt-1/PlGF ratio in patients with preeclampsia as compared to controls & patients with chronic/gestational hypertension. Other work has examined the longitudinal changes in the individual values of sFlt-1 & PlGF over the course of the pregnancy, as well as the ratio. Given the low prevalence of preeclampsia in the population, the positive predictive value remained low, however the negative predictive value approached 97% late in gestation. This suggests that the utility of the sFlt-1/PlGF may be in its ability to rule out preeclampsia. More recently the PROGNOSIS study was designed to investigate the value of the sFlt-1/PlGF ratio for the prediction of the presence or absence of preeclampsia in the short term & found that a cutoff point of 38 for the sFlt-1/PlGF ratio is useful for predicting the short-term absence of preeclampsia in women with suspected disease (Negative predictive value 99.3% for ruling out preeclampsia within 1 week). Hypothesis: In women with chronic hypertension, the sFlt-1/PlGF ratio will better predict the development of superimposed preeclampsia than clinical criteria alone.

NCT ID: NCT03419364 Completed - Pregnancy Related Clinical Trials

Study of Nicotinamide in Early Onset Preeclampsia

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.

NCT ID: NCT03412552 Completed - Clinical trials for Hypertensive Disorder of Pregnancy

Risk Analysis of Intensive Care Mangement on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia

Start date: October 1, 2015
Phase: N/A
Study type: Observational

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests. ICU management during conduction of the research study included the following: Control of convulsions using magensium sulphate. Control of blood pressure Diastolic blood pressure above 110 mmHg, nifedipine was administered.A plasma volume expansion with saline was used in all women to maintain sufficient intravascular volume. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .

NCT ID: NCT03399006 Not yet recruiting - Preeclampsia Clinical Trials

Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy as Predictors Of Preeclampsia?.

Start date: January 2018
Phase: N/A
Study type: Observational

200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and resistivity index (RI) in both uterine arteries, and assessment of the placental volume and its vascular indices (VI, FI, VFI)

NCT ID: NCT03391609 Completed - Pre-Eclampsia Clinical Trials

Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Start date: June 18, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.

NCT ID: NCT03360240 Completed - Clinical trials for Preeclampsia and Eclampsia

Blood Pressure in Adolescents With PReclampsia and Eclampsia.

ADPRE
Start date: August 1, 2017
Phase:
Study type: Observational [Patient Registry]

Levels of blood pressure in adolescents with preeclampsia and eclampsia: Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia. The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg. The sample is 1050: (350 Cases and 700 Controls).

NCT ID: NCT03356106 Completed - Clinical trials for Sleep Apnea, Obstructive

Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

Start date: November 16, 2016
Phase: N/A
Study type: Interventional

This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.

NCT ID: NCT03349671 Not yet recruiting - Pre-Eclampsia Clinical Trials

Predictors of Intrauterine Growth Restriction

Start date: October 2018
Phase:
Study type: Observational

The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible. The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements & 3-dimensional (3D) representation became feasible further revolutionizing this area

NCT ID: NCT03342014 Completed - Pre-Eclampsia Clinical Trials

First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography

SPIRIT
Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Introduction: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to a chronic utero-placental hypoperfusion. Nowadays, there isn't a screening or diagnostic test in clinic for utero-placental vascularization deficiency. Since 2004, 3D Power Doppler angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). A high intra and inter-observer reproducibility and its potential interest for placental function study were reported. The investigator's main hypothesis is that these 3DPD indices could provide predictive values for PE and/or IUGR occurrence much higher than those observed with the currents other markers. Objectives: The main objective of this study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women. Methods and analysis: This is a prospective study. The investigators expect to include 2200 women in 4 French centers: Centre Hospitalier Universitaire de Nancy, Paris-Port-Royal (Assistance Publique - Hôpitaux de Paris), Strasbourg and Belfort (Hôpital Nord Franche-Comté). The nulliparous pregnant women will be recruited during their 1st trimester consultation for routine Down syndrome screening (11-13+6 gestation weeks). Especially for the study, the 3DPD and Uterine Artery Doppler (UAD) acquisition, which last less than 10 min, will be included in the current routine 11-13+6 gestation weeks ultrasound screening. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Utero-placental vascularization indices (VI, FI, VFI) will be quantified using VOCAL® software. For each subgroup (uncomplicated pregnancy, PE and IUGR) mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.

NCT ID: NCT03334149 Completed - Hypertension Clinical Trials

Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension

BUMP
Start date: November 22, 2017
Phase: N/A
Study type: Interventional

Raised blood pressure is a common problem in pregnancy. Raised blood pressure and pre-eclampsia affect about one in ten women and are a major cause of death and premature birth in the United Kingdom and worldwide. Many women have expressed an interest in monitoring their own blood pressure in between antenatal visits but there has been very little research to guide this. The investigators would like to know if the diagnosis and subsequent care of women with raised blood pressure can be improved if women were able to monitor their own blood pressure safely at home. This work will test whether optimising the diagnosis, monitoring and management of raised BP during pregnancy through self-monitoring of BP is effective, acceptable and cost-effective compared to usual care. The research team have being working with pregnant women, doctors and midwives to develop a simple and accurate method of self-monitoring of blood pressure in pregnancy. This randomised controlled trial will: 1. Compare self-monitoring with usual care in women at higher risk of hypertension in pregnancy and assess if self-monitoring can identify raised blood pressure earlier. 2. Compare self-monitoring with usual care for women with high blood pressure in pregnancy to see if it leads to lower blood pressure. 3. Assess if self-monitoring is cost-effective. Pregnant women who chose to take part in these studies will be randomised to either usual care or asked to monitor their own blood pressure during their pregnancy in addition to their usual antenatal care.