Status:
COMPLETED
Circulating Oxidative Stress and Gestational Hypertension. Study of the Evolution of Free-radical Markers of Oxidative Stress From Before to After Childbirth in Two Groups of Women: Normal Pregnancy and Pre-eclampsia.
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Pregnancy Complicated by Pre-eclampsia.
Normal Pregnancy
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The aim of this study is to explore a mechanism that could potentially explain why women with a pregnancy complicated by pre-eclampsia are described as having an increased risk of cardiovascular disea...
Eligibility Criteria
Inclusion
- Patients who have provided written informed consent
- Patients covered by a Health Insurance scheme
- Age \> 18 years
- Normal pregnancy
- or pre-eclampsia defined according to the following classical criteria: (i) de novo hypertension defined by arterial blood pressure of at least 140 mm Hg (systolic) or at least 90 mm Hg (diastolic) confirmed by at least two measurements separated by at least 4-6 h, occurring after the 20th week of gestation in a women known beforehand to have a normal blood pressure, (ii) proteinuria defined by urinary excretion of at least 300 mg of protein per 24 h. If 24-hour urine is not available, proteinuria is defined as a concentration of urinary protein of 300 mg/L or more (or \>1 + on the urinary dip) in at least two samples of urine taken randomly, but at an interval of at least 4-6 h \[7\]. Pre-eclampsia is defined as severe if: persistent systolic BP \> 170 mm Hg and/or diastolic BP \> 110 mm Hg, and/or diuresis \< 30 ml/hour, and/or at least 2 of the following signs (headache, phosphenes, epigastric pain or vomiting, pyramidal-type patellar reflexes, papilledema, hepatic pain, thrombopenia \< 100x106 /l, ALT AST \> 70 UI/l and or hemolysis manifesting as haptoglobin \< 0.06 g/l, or a fall in LDH or the presence of schistocytes, the latter three signs define the HELLP syndrome) and/or seizures.
- Term\> 26 SA.
Exclusion
- Refusal to provide consent
- Context of patent infection.
- Premature rupture of the fetal membranes.
- preexisting or gestational diabetes.
- Vasculoplacental diseases other than pre-eclampsia: placental abruption or infarction, intrauterine growth retardation of in utero fetal death not occurring in a context of pre-eclampsia.
- Chronic or gestational AHT not meeting the criteria for pre-eclampsia.
- Twin/multiple pregnancies
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01907620
Start Date
November 1 2010
End Date
November 1 2011
Last Update
July 25 2013
Active Locations (1)
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1
CHU de Dijon
Dijon, France, 21079