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Pre-eclampsia clinical trials

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NCT ID: NCT00300937 Completed - Preeclampsia Clinical Trials

Coenzyme Q10 Supplementation and Development of Preeclampsia

Start date: July 2004
Phase: Phase 3
Study type: Interventional

As preeclampsia is a disease specially affecting young and primiparous women, and due to the fact that we found previously in several studies a prevalence of 12%, to ensure a confidence of 95% and a power of 80%, it is necessary to include a total of 190 women (95 in each arm), therefore it is planned to recluse a total of 200 pregnant women currently attending to the outpatients clinic at the HGOIA for pregnancy control before than week 20 of gestation. From each one of those women the clinical research team will obtain an obstetric, anthropometric and clinical record following the current regulations of the Ecuadorian Public Health Ministry. All women included will be under a detailed prenatal control every 4 weeks from week 20 of pregnancy, this will include gestational age, weight, umbilical perimeter, uterine altitude, fetal cardiac frequency and maternal blood pressure. In addition, in each schedule visit an urine test will be done (to discard proteinuria), also a venous blood sample (10 ml) in heparinized tubes will be taken and immediately transported to the Biomedical Center for centrifugation and plasma isolation. During week 20, all women will be assigned (using a randomized numbers table) to one of the following groups: a) intervention group, that will received two capsules of 100 mg of coenzyme Q10 twice daily up to delivery; or b) control group, that will receive two capsules of the correspondent placebo twice daily up to delivery. Both, active and placebo capsules will be manufactured by the same provider (Jarrow Formulas, Los Angeles, CA, USA) to guarantee that weight, size, odor and color are similar. Absolutely all women participating in the study will know all contact information of the clinical team and will be allowed to request medical care as frequent as they needed, independently of establish obstetrical controls. Preeclampsia diagnosis will be performed only by clinical researchers and based on a persistent high blood pressure higher than 140/90 mmHg and proteinuria higher than 300 mg/24 hours. Coenzyme Q10 will be measured using a high performance liquid chromatography equipment (HPLC) and the method previously described and validated by our group. The hypothesis is that in the group receiving CoQ10 supplementation will be less cases of preeclampsia compared to placebo.

NCT ID: NCT00275158 Completed - Pre-Eclampsia Clinical Trials

Glomerular Injury of Preeclampsia

Start date: January 2000
Phase: N/A
Study type: Interventional

Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.

NCT ID: NCT00259688 Completed - Preeclampsia Clinical Trials

Prevalence Study of Sleep Apnea in Women With Preeclampsia

Start date: February 2006
Phase: Phase 2
Study type: Interventional

Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

NCT ID: NCT00201500 Completed - Preeclampsia Clinical Trials

Left Ventricular and Endothelial Function in Preeclampsia

Start date: October 2004
Phase: Phase 1/Phase 2
Study type: Observational

The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there is a post partum impairment in left ventricular and endothelial function.

NCT ID: NCT00199810 Completed - Preeclampsia Clinical Trials

Hemodynamic Measurements in Women With Serious Preeclampsia

Start date: July 2005
Phase: Phase 4
Study type: Observational

This trial is examining hemodynamic measurements in women with serious preeclampsia.

NCT ID: NCT00197340 Completed - Pre-Eclampsia Clinical Trials

Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction

Start date: August 2003
Phase: Phase 3
Study type: Interventional

Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.

NCT ID: NCT00190177 Completed - Preeclampsia Clinical Trials

ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury

Start date: March 2003
Phase: N/A
Study type: Observational

The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

NCT ID: NCT00187395 Completed - Clinical trials for Transient Hypertension, Pregnancy

CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

Start date: April 2003
Phase: N/A
Study type: Interventional

Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.

NCT ID: NCT00181077 Completed - Preeclampsia Clinical Trials

Hypertonic Saline Use in Preeclampsia

Start date: June 2003
Phase: Phase 1
Study type: Interventional

To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up the process of getting rid of extra body water faster in women with preeclampsia.

NCT ID: NCT00175695 Completed - Pre-eclampsia Clinical Trials

Disease Modification in Toxaemia of Pregnancy

Start date: December 2004
Phase: Phase 2
Study type: Observational

Short description of the primary purpose of the protocol intended for the lay public. Include brief statement of study hypothesis Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North America. It also causes many complications for fetuses (unborn children) and neonates (newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss of protein into the urine (proteinuria), and disorders of many body systems, including the blood clotting (coagulation) and inflammation. What is needed is a compound that will safely prolong pregnancies, to give babies more time to grow inside their mothers, and will help the recovery in those mothers after delivery. We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered (including women in the first group), or whose disease develops/worsens after delivery (intent: switch off the disease so dangerous complications do not arise). This study is a preliminary one to look for possible risks and benefits for these women. Only 40 women will be studied to provide initial evidence on which to base a larger international trial which is planned. We will study their pregnancy outcomes as well as markers of disease activity, to gain a better understanding of the mechanisms by which these women become unwell.