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Preeclampsia clinical trials

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NCT ID: NCT00826696 Completed - Preeclampsia Clinical Trials

A Retrospective Review of the Seasonality of Pre-Eclampsia

Start date: January 2009
Phase: N/A
Study type: Observational

This retrospective review will will attempt to determine whether our data show a significant difference in number of deliveries of women with pre-eclampsia compared to deliveries without pre-eclampsia during certain months of the year.

NCT ID: NCT00789919 Completed - Preeclampsia Clinical Trials

Mild Preeclampsia Near Term: Deliver or Deliberate?

Start date: March 2002
Phase: N/A
Study type: Interventional

Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.

NCT ID: NCT00787241 Completed - Preeclampsia Clinical Trials

Platelet Count Trends in Pre-eclamptic Parturients

Start date: September 2002
Phase: N/A
Study type: Observational

Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy; therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial analgesia in women with preeclampsia/eclampsia. Catheter removal is also contraindicated in the presence of a coagulopathy. Some women have an acceptable PC at the initiation of neuraxial analgesia, but may become significantly more thrombocytopenic during labor and delivery. In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC correlated with the PC nadir. However, the natural progression of the PC has not been studied in women with mild preeclampsia. We hypothesize that women with mild preeclampsia or severe preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will have a stable PC during the course of labor and delivery and do not require another PC check prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose of this study is to determine the positive predictive value of an initial PC greater than 150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.

NCT ID: NCT00763672 Completed - Hypertension Clinical Trials

MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

MOMA
Start date: November 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether close monitoring of patients with a high sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary PlGF screening will be effective.

NCT ID: NCT00757718 Completed - Clinical trials for Obstructive Sleep Apnea

Sleep Disordered Breathing and Gestational Hypertension

Start date: December 2008
Phase: N/A
Study type: Interventional

Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.

NCT ID: NCT00741312 Completed - Pregnancy Clinical Trials

Influence of Physical Exercise on Endothelial Function in Pregnant Women

Start date: October 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.

NCT ID: NCT00719654 Completed - Preeclampsia Clinical Trials

Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

Start date: August 2007
Phase:
Study type: Observational

The hypothesis of this study is that many plasma proteins are altered in concentration and structure in preeclampsia and the elucidation of these alterations will add to the poorly understood pathophysiology of preeclampsia. In this study we will compare the maternal plasma proteomes of early-onset severe preeclampsia versus healthy controls, compare protein expression and quantification of the maternal plasma proteome at the time of diagnosis of EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post delivery and we will verify the placental expression of differentially expressed or post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.

NCT ID: NCT00719537 Terminated - Preeclampsia Clinical Trials

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Start date: July 2008
Phase: N/A
Study type: Interventional

Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia. Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. HLA-G is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells. In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.

NCT ID: NCT00683202 Completed - Pregnancy Clinical Trials

Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

Start date: March 2001
Phase: N/A
Study type: Interventional

In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.

NCT ID: NCT00666133 Completed - Preeclampsia Clinical Trials

Treatment Approaches for Preeclampsia in Low-Resource Settings

Start date: April 2008
Phase: N/A
Study type: Interventional

Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia. Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits. The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.