Pre-Eclampsia
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm clinical study. Experimental group: 25 women with severe preeclampsia will receive daily vitamin E supplementation in the form of capsules conta
Sponsors
Departamento de Análises Clínicas e Toxicológicas
Universidade Federal do Rio Grande do Norte
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women aged = 18 years, diagnosed with severe preeclampsia, defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =110 mmHg or the presence of other clinical and laboratory alterations, such as: severe headache, chest pain, dyspnea, O2 saturation <97%, leukocytosis, thrombocytopenia, elevated creatinine and uric acid, nausea, vomiting, epigastric pain, elevated bilirubin, plasma albumin, low non-reactive cardiotocography, oligohydramnios, umbilical artery Doppler with absent or reversed dialysis flow, will be included. The inclusion criteria also include pregnant women with inadequate levels of serum alpha tocopherol (= 30 mmol), from the 20th gestational week, with a single fetus and followed up at the high-risk multidisciplinary prenatal outpatient clinic at the Januário Cicco Maternity Hospital
Exclusion criteria
Exclusion criteria: Women with a previous or current diagnosis of Diabetes Mellitus or Gestational Diabetes Mellitus, cases of multiple pregnancies, pregnant women who smoke, have allergies or are taking supplements containing vitamin E above 50 IU, who are using illicit drugs or alcohol during the current pregnancy, have fetal abnormalities, have documented uterine bleeding within one week of screening, have pregnancies resulting from in vitro fertilization, have thrombophilia, are carriers of Human Immunodeficiency Virus, syphilis and systemic lupus erythematosus will be excluded from this study. Women with serum tocopherol levels > 30 mmol/L and whose delivery does not take place at the Januário Cicco Maternity Hospital will also be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An average reduction of at least 4 micronuclei per thousand blood cells is expected between the intervention group and the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the frequency of nucleoplasmic bridge and nuclear bud, using the Micronucleus test with Cytokinesis Block, in the intervention and control groups;To assess changes in the lipid profile (Triglycerides, Total Cholesterol and LDL-c), performed by means of spectrophotometry of blood samples from the intervention and control groups, at the beginning of the study and at the end of the study;To assess changes in the renal profile by determining TGFe, creatinine, urea, RAC of blood and urine samples from the intervention and control groups, at the beginning of the study and at the end of the study;To assess changes in the liver profile by determining AST/ALT in blood samples from the intervention and control groups, at the beginning of the study and at the end of the study;To evaluate changes in the nutritional profile of breast milk by determining alpha-tocopherol levels, fatty acid profile and antioxidant profile of blood samples from the intervention and control groups, at the beginning of the study and at the end of the study;To assess changes in maternal serum vitamin E nutritional profile by determining alpha-tocopherol levels in blood samples from the intervention and control groups, at baseline and at the end of the study | — |
Countries
Brazil
Contacts
Public ContactAdriana Rezende
Universidade Federal do Rio Grande do Norte
Outcome results
None listed