Unspecified pre-eclampsia
Conditions
Interventions
A triple-blind Randomized Controlled Clinical Trial (RCT) will be carried out. Pregnant women will be centrally allocated to one of three groups: experimental group I, experimental group II and contro
Sponsors
Centro de Ciências Biológicas e da Saúde - Universidade Federal de Sergipe
Universidade Federal de Sergipe
Eligibility
Sex/Gender
Female
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women who are up to the 20th week of pregnancy at the first stage of the approach; minumium age of 15 years; who present one or more of the risk factors: history of pre-eclampsia, multiple pregnancy, chronic hypertension, type 1 or 2 diabetes, autoimmune disorder) will be included in the study. , kidney disease, nulliparity, body mass index >30 kg/m2, family history of preeclampsia (first-degree relative), sociodemographic characteristics (African American, low socioeconomic status), age >35 years, history factors (pre-low birth weight or small birth for gestational age, previous adverse pregnancy outcome, interval >10 years since previous pregnancy, term birth without previous complications) for the occurrence of pre-eclampsia; and/or low intake of calcium
Exclusion criteria
Exclusion criteria: Pregnant women with known placental abnormalities; current pregnancy as a result of in vitro fertilization; regular use of platelet-active drugs; known fetal abnormalities; uterine bleeding documented within one week of screening; uterine malformations; pregnant women with chronic systemic hypertension; sickle cell anemia; those under 15 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A sample of at least 120 patients in each group is expected to provide 80% power to detect a 50% reduction in the incidence of PE and the estimate that 30% of high-risk pregnant women develop pre-eclampsia, using a two-sided t-test with an a level of 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactCinara Rejane Oliveira
Universidade Federal de Sergipe
Outcome results
None listed