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Pre-eclampsia clinical trials

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NCT ID: NCT03008616 Terminated - Severe Preeclampsia Clinical Trials

Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia

Start date: April 12, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.

NCT ID: NCT02935556 Terminated - Clinical trials for Post Partum Pre-eclampsia

Characterization and Epigenetics of Post-Partum Preeclampsia

Start date: February 1, 2017
Phase:
Study type: Observational

This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

NCT ID: NCT02613793 Terminated - Pre-eclampsia Clinical Trials

Saccadic Reaction Time and Preterm Pre-eclampsia

Start date: January 2016
Phase:
Study type: Observational

This study is recruiting two groups of women over the age of 18; those who are pregnant and who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to seizures in pregnancy (eclampsia) and may prove fatal for mother and child. Currently the only effective treatment for pre-eclampsia is control of the mother's blood pressure until it is safe to deliver the baby. The timing of delivery is kept under constant review by the medical team, who must balance the risk to the mother of developing eclampsia against the risk to the baby of being born too early (premature). If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing this is not easy, so we want to assess whether measuring other reaction times might similarly help assess the risk of seizures. One possibility is by measuring the reaction time as we flick our eyes to follow a moving target, using an instrument called a saccadometer, which is worn on a head-band, a little like a head-torch. By comparing the results between these groups and the non-pregnant women, we will be able to see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if so, whether saccadometry might be useful in helping doctors decide the best time for safe delivery.

NCT ID: NCT02558023 Terminated - Hypertension Clinical Trials

The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

Uranic
Start date: September 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated. - efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration. - safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h). Pharmacokinetic study included to study : - transplacental transfer, - transfer in breast milk, - and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))

NCT ID: NCT02396030 Terminated - Preeclampsia Clinical Trials

Different Schemes of Magnesium Sulfate for Preeclampsia

MGSO4
Start date: March 2015
Phase: Phase 4
Study type: Interventional

Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures, there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are still questions regarding its use and dose. The scheme and the optimal time of administration remain to be elucidated. The objective of this trial is to compare the effectiveness and safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or superimposed).

NCT ID: NCT02303834 Terminated - Hypertension Clinical Trials

CPAP in Preeclampsia

Start date: February 2015
Phase: N/A
Study type: Interventional

Study design: Single blinded randomised control trial Planned sample size: 30 (women randomized 2:1 to receive either CPAP or no CPAP) Objectives: Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia. Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR monitors. Study Procedure: Participants will be recruited from the antenatal ward or high-risk antenatal clinic. Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night, following an initial baseline overnight sleep study. Baseline- Night 1 1. Sleep study with fetal movement and HR monitor 2. 24 hour BP monitor 3. CO2 monitor Intervention- Night 2 (Nasal CPAP device or no CPAP) 1. Sleep study with fetal movement and HR monitor 2. 24 hour BP monitor 3. CO2 monitor Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participant's personal health, their child's birth details and health.

NCT ID: NCT02286284 Terminated - Preeclampsia Clinical Trials

Usefulness of Extracorporeal Removal of sFLT-1 in Women With Very Early Severe Preeclampsia

ADENA
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Introduction Preeclampsia is a multifactorial disease that is responsible of important adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental models and circulates at elevated levels in human preeclampsia. The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in women with very early severe preeclampsia at less than 26 weeks' gestation Patients and methods Phase II trial. Women with singleton pregnancy having severe preeclampsia at 23-256/7 weeks' gestation. Women under 18 years, with multiples, or severe fetal growth restriction (less than 5th centile), or abnormal fetal heart rate, or maternal complications (abruption, eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded from the study. After blood pressure and maternal stabilization, women are approached for information and if they agree, to sign the trial consent. Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation. Primary endpoint or success of the procedure: baby alive or alive at 6 months if hospitalized Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%, beta power; 90%. First step: number 8 patients. If success equal or less than 5, the study is stopped. Second step: if success of 6 or more, the study is continued for 9 more patients. Overall, a maximum of 17 patients will be included. The final success of extracorporeal removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months if hospitalized.

NCT ID: NCT02174328 Terminated - Pre-Eclampsia Clinical Trials

Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes.

PROVAS
Start date: May 21, 2014
Phase: Phase 3
Study type: Interventional

The main objective of this trial is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy and to compare the results with those obtained in patients receiving placebo.

NCT ID: NCT02025426 Terminated - Pre-eclampsia Clinical Trials

Phenylephrine Versus Ephedrine in Pre-eclampsia

Start date: September 2012
Phase: Phase 4
Study type: Interventional

Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.

NCT ID: NCT01566630 Terminated - Pre-eclampsia Clinical Trials

Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.