Gestational (pregnancy induced) hypertension with or without significant proteinuria
Conditions
Interventions
Trade Name: E-GEMS with C
Product Name: E-GEMS with C
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Ste-Justine Hospital - Montréal in the name of Canadian Institute of Health Research (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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 Stratum Women who are having their first baby. Strata II High Risk Stratum Women 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of gestational hypertension (with or without proteinuria) and its adverse condition(s) .;Primary end point(s): Gestational hypertension (with or without proteinuria) and its adverse condition(s). The adverse conditions must include : Diastolic pressure > 110 mmHg or systolic pressure > 160 mmHg; Proteinuria > 300 mg/ 24 hours urine collection; Convulsion (eclampsia); Thrombocytopenia; Elevated liver enzyme levels; Creatinine > 180 µmol/L; Hematocrit < 24 and blood transfusion; Intrauterine growth restriction <3rd centile; Perinatal death. Gestational hypertension with adverse conditions occurring during labour and postpartum will be included. ;Secondary Objective: 1. To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of pre-eclampsia. 2. To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of the following maternal and neonatal outcomes : Maternal Outcomes: maternal death, severe preeclampsia (severe gestational hypertension plus proteinuria), preterm delivery before 37 weeks of pregnancy (gestational age corrected by early ultrasound scan), premature rupture of membranes antenatal inpatient days. Neonatal Outcomes: intrauterine growth restriction (IUGR); < 3rd centile, perinatal mortality, spontaneous abortion, neonatal morbidity indicators, retinopathy of prematurity, leukomalacia, thrombocytopenia, neutropenia, early onset sepsis, necrotising enterocolitis, intraventricular haemorrhage, ventilation, need for O2 at 28 days, length of stay in Neonatal Intensive Care Unit. | — |
Countries
Belgium
Outcome results
None listed