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.

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.

Study Overview

• Status: Completed
• Conditions: Normal Pregnancy; Pregnancy Complicated by Pre-eclampsia.
• Intervention / Treatment: Other: blood sample

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal pregnancy; women pregnant	Other: blood sample
Other: pregnancy complicated by pre-eclampsia; women with pregnancy complicated by pre-eclampsia	Other: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quantification of radical species	baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Sagot PHRC IR 2007