INternational Trial of Antioxidants for the Prevention of Preeclampsia(INTAPP) - INTAPP

Conditions: Gestational (pregnancy induced) hypertension with or without significant proteinuria

Registration Number: EUCTR2004-003793-29-BE

Lead Sponsor: Ste-Justine Hospital - Montréal in the name of Canadian Institute of Health Research (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 12500

Inclusion Criteria

Women with age of majority who are between 12 and 18 completed weeks of pregnancy would be assigned to one of two strata (See Table I). Gestational age of patients will be based on the last menstrual period and confirmed by early ultrasound examination.

Table 1 : INTAPP Risk Strata Participants
Strata I Low Risk StratumWomen who are having their first baby.
Strata II High Risk StratumWomen who are having their first or second (or more) baby with pre-pregnancy chronic hypertension (or diastolic blood pressure 90 mmHg before 20 gestational weeks or use of antihypertensive medication), or pre-pregnancy diabetes (insulin-dependent or hypoglycemic agents), or multiple pregnancy, or women with a history of preeclampsia in the previous pregnancy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Women who regularly consume supplements greater than 200 mg/day for vitamin C and/or 50 IU/day for vitamin E.
b. Women who take warfarin (because of theoretical potentiation of warfarin by vitamin E).
c. Women who have known foetal abnormalities (e.g. hydatidiform mole), or known fetal chromosomal or major malformations in the current pregnancy.
d. Women who have a history of medical complications including:
•endocrine disease such as thyroid disease
•renal disease with altered renal function
•epilepsy
•any collagen disease such as lupus erythromatosus and scleroderma
•active and chronic liver disease (hepatitis)
•heart disease
•serious pulmonary disease
•cancer
•haematologic disorder (patient with anaemia or thrombophylias will be included)
e. Women with repeated spontaneous abortion. .Woman with a previous bleeding in the first trimester, can be included if the site documents a viable fetus at the time of recruitment.
f. Women using illicit drug or alcohol regular use of during current pregnancy. Smokers are eligible. We will capture the number of cigarettes per day the patient smokes. In addition, information on the exposition to second-hand smoking will be also captured.