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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.

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ClinicalTrials.gov Identifier: NCT01907620
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pregnancy Complicated by Pre-eclampsia. Normal Pregnancy Other: blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Normal pregnancy
women pregnant
Other: blood sample
pregnancy complicated by pre-eclampsia
women with pregnancy complicated by pre-eclampsia
Other: blood sample



Primary Outcome Measures :
  1. quantification of radical species [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907620


Locations
France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01907620     History of Changes
Other Study ID Numbers: Sagot PHRC IR 2007
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications