Gestational hypertension with or without proteinuria (preeclampsia) Pregnancy and Childbirth Gestational hypertension
Conditions
Interventions
Group One (Experimental): Daily supplementation with 1 g Vitamin C, 400 IU Vitamin E
Group Two (Control): Matching placebo
The duration of the follow-up varies for each participant. The woman is rand
Sponsors
Hospital Sainte-Justine (Montréal) (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. The woman is pregnant between 12^0/7 and 18^6/7 completed weeks 2. At least 18 years of age 3. Speaks a language known by the medical staff 4. Plans to deliver in a participating hospital
Exclusion criteria
Exclusion criteria: 1. Daily Vitamin C intake equal or more than 200 mg 2. Daily Vitamin E intake equal or more than 50 IU 3. Uses warfarin (coumadin) 4. Known major foetal abnormalities, including chromosomal anomalies in the current pregnancy 5. Has one of the following conditions: 5.1. Untreated hypo/hyperthyroidism 5.2. Renal disease with altered renal function (creatinine more than two times the upper limit of the normal range value) 5.3. Any collagen vascular disease (including lupus erythromatosus, scleroderma) 5.4. Active or chronic hepatitis 5.5. Epilepsy 5.6. Cancer 5.7. Threatened abortion (the woman had two or more miscarriages) 5.8. Illicit drug use or alcohol abuse (more than or equal to two drinks a day during current pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gestational hypertension, with or without proteinuria and adverse conditions. The data is recorded from the medical chart after post-partum hospital discharge. The period covered is: pregnancy, from randomisation to post-partum hospital discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome indicators are assessed from randomisation until post-partum hospital discharge. The following sources are used: prenatal record from treating MD, data recorded in CRF by study nurse at the three follow-up visits, postpartum and newborn hospital chart of mother and baby. The period covered is: pregnancy, from randomisation to postpartum hospital discharge. 1. Preeclampsia 2. Maternal death 3. Severe preeclampsia 4. Preterm delivery less than 32 and less than 37 weeks? gestation (gestational age corrected by early ultrasound scan) 5. Intrauterine growth restriction (less than third centile) 6. Perinatal mortality 7. Spontaneous abortion 8. Premature rupture of membranes 9. Antenatal inpatient days 10. Neonatal mortality indicators | — |
Countries
Argentina, Belgium, Canada, China, Mexico
Outcome results
None listed