None listed
Conditions
Interventions
Vitamin C and E Type of group
Early administration, of 1000 mg of vitamin C and 400 IU of vitamin E, to pregnant women at high risk to develop pre-eclampsia, reduces the incidence of preeclampsia, compared with a group of high-risk women who will receive a placebo.
Sponsors
ORGANIZACION PANAMERICANA DE LA SALUD,
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant women will be recruited between the weeks of pregnancy, based on the last rule date, they will enter the study if they have one or more of the following risk factors: • Chronic hypertension o Diastolic pressure> 90mmHg at the first visit (before 20 weeks of gestation) • Pre-gestational Diabetes o Pre-gestational diagnosis that requires medication and / or diet to control serum glucose levels, or One or more episodes of arterial, venous thrombosis, small vessels in any organic tissue.
Exclusion criteria
Exclusion criteria: • Inability to give informed consent (Pregnant women under age will be recruited according to local legislation). • Women who receive vitamin supplements containing> 200mg vitamin C or> 50IU vitamin E daily dose. • Women receiving warfarin (Due to the theoretical potentiation of warfarin by vitamin E).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as gestational hypertension and proteinuria Measure:Occurrence of preeclampsia. Timepoints:throughout the pregnancy up to 72 hours postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Low birth weight, defined as less than 2.5kg, • Small for gestational age (PEG), defined as weight <5th percentile for gestational age, according to weight tables by gestational age. Other Measurements of Secondary Indicators (also very important to detect relevant effects). • Plasma measurements of malondialdehyde, glutathione, vitamin C, vitamin E measured longitudinally in a selected cohort. • Preterm births (before 37th weeks) • Use of health resources: Days of prenatal hospitalization. • Gestational age at birth. Measure:Main Neonatal Indicators Timepoints:throughout the pregnancy up to 72 hours postpartum | — |
Countries
Peru
Outcome results
None listed