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.

Normal Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907620
• Other study ID #: Sagot PHRC IR 2007
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 22, 2013
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Eclampsia
• Normal Pregnancy
• Pre-Eclampsia
• Pregnancy Complicated by Pre-eclampsia.

Intervention

Other:
• blood sample

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantification of radical species		baseline	No