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.

Not Applicable

Completed

• Conditions: Pregnancy Complicated by Pre-eclampsia.; Normal Pregnancy
• Interventions: Other: blood sample

• Registration Number: NCT01907620
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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 disease later in life.

If the hypothesis of this study turns out to be true, that is to say that women with pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and that this difference persists after the delivery (6 months), a controlled randomized interventional study aiming to evaluate either therapeutic supplementation with antioxidant vitamins (Vit C and E) or modifications in diet could be envisaged.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-22
• Last Update Submitted: 2013-07-22
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal pregnancy	blood sample	women pregnant
pregnancy complicated by pre-eclampsia	blood sample	women with pregnancy complicated by pre-eclampsia

Primary Outcome Measures

Name	Time	Method
quantification of radical species	baseline

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France