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Pre-eclampsia clinical trials

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NCT ID: NCT03971604 Recruiting - Preeclampsia Clinical Trials

The Correlation Between Vitamin A / E Levels and Preeclampsia

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Vitamin A (VA) and vitamin E (VE) are fat-soluble vitamins and indispensable substances in life activities. VA plays an important role in visual function, normal formation and development of epithelial cells, development and growth of bones, immune function and reproductive health. VA is of great significancCe for the growth and development of embryonic cells, especially for the development of fetal vertebrae, spinal cord, limbs, heart, eyes and ears. The lack of maternal VA will lead to the stunted development of fetal organs and tissues, and even fetal developmental malformation. In addition, VA has a protective effect on neonatal lung maturation.VA deficiency can cause the decrease in the activity of enzymes needed to catalyze the formation of progesterone precursors in pregnant women, reduce the production of steroids in adrenal glands, gonads and placenta, and seriously affect the functions of multiple organs such as heart, liver and skeletal muscle in pregnant women. VE, also known as tocopherol, has non-enzymatic antioxidant function, and maintains the balance of REDOX reaction in vivo by efficiently removing free radicals generated by lipid peroxidation.VE can increase the synthesis of nitric oxide (NO) in endothelial cells and improve vascular endothelial function. Long-term administration of VE can improve the impaired endothelium-dependent vasodilatory function in patients.VE can promote sex hormone secretion, improve fertility and prevent abortion. Pregnancy women the body's metabolism, increases produce free radicals, lipid peroxidation, low levels of VE will result in the accumulation of excess free radicals, cause the placenta aging, vascular endothelial damage, increase the risk of the occurrence of PHI and adverse outcome rate, as well as the membranes of cell membrane damage, increase the risk of premature rupture of membranes. Gestational hypertension is a group of diseases with both pregnancy and elevated blood pressure, and is the main cause of increased maternal and perinatal mortality, mainly including gestational hypertension, preeclampsia PE, and eclampsia, as well as chronic hypertension with preeclampsia and chronic hypertension with pregnancy. The cause of PE is unknown, but studies have found that it may be related to insufficient recast of spiral uterine arterioles, excessive activation of inflammatory immune system, damage of vascular endothelial cells, genetic factors, nutritional deficiency and insulin resistance. Recent studies have found that free radical oxidative damage may also be one of the main reasons for the occurrence and development of PE. PE occurs, the placenta bed vasospasm, ischemia, angiogenesis blocking and endothelial atherosclerotic changes, local immune cell activity, make produce free radicals increases, interfere with the vascular endothelial cell function, reduce vascular relaxation material synthesis, and shrink blood vessels increase material synthesis, promote vascular spasm, platelet condensed state is changed, thus appeared a series of PE. Previous studies have shown that oxygen free radicals and lipid peroxides are increased in PHI patients, while the levels of VA and VE are closely related to the antioxidant capacity of the body, and their lack can lead to the imbalance of the homeostasis of redox reaction in multi-tissue cells in the body. Since both VA and VE belong to fat-soluble vitamins and are widely distributed in daily food, whether their effects on the occurrence and development of PE are independent or combined will be a question for us to explore. Therefore, this study intends to evaluate the correlation between VA, VE and VA+VE and PE occurrence through multi-center clinical studies, and explore and summarize the feasibility of VA and VE in PE adjuvant treatment.

NCT ID: NCT03928691 Recruiting - Pre-Eclampsia Clinical Trials

Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level

Start date: June 30, 2019
Phase:
Study type: Observational

Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it.

NCT ID: NCT03903393 Recruiting - Preeclampsia Clinical Trials

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

Start date: March 31, 2019
Phase:
Study type: Observational

To identify lncRNAs differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with normal pregnancy .

NCT ID: NCT03893630 Recruiting - Pre-Eclampsia Clinical Trials

Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia

ASPERIN
Start date: April 25, 2019
Phase: Phase 2
Study type: Interventional

Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.

NCT ID: NCT03882099 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia

Start date: March 17, 2019
Phase:
Study type: Observational

To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.

NCT ID: NCT03858595 Recruiting - Clinical trials for Hypertension in Pregnancy

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Background: 1. 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. 2. 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. 3. 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: 1. To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure. 2. 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: 1. Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc. 2. 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 3. Serious adverse events

NCT ID: NCT03838887 Recruiting - Pre-Eclampsia Clinical Trials

Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

Start date: June 1, 2021
Phase:
Study type: Observational

• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

NCT ID: NCT03824119 Recruiting - Preeclampsia Clinical Trials

Postpartum NSAIDS and Maternal Hypertension

Start date: December 11, 2018
Phase: Phase 4
Study type: Interventional

Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum. This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.

NCT ID: NCT03806283 Recruiting - Vascular Diseases Clinical Trials

Mechanisms of Pregnancy Vascular Adaptations

Start date: November 20, 2018
Phase:
Study type: Observational

The investigators will collect omental tissue (research surgical excision) and placental tissue (standard of care clinical delivery) from both preeclamptic and non-preeclamptic women during their c-section and use these samples to study the blood vessels, specifically the expression/activation of the AT2R.

NCT ID: NCT03761888 Recruiting - Preeclampsia Severe Clinical Trials

Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

PREMODYM
Start date: November 29, 2018
Phase:
Study type: Observational [Patient Registry]

Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.