Official Title
Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to Coronavirus SARS-CoV-2
Brief Summary

This research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.

Detailed Description

The present study will be included pregnant women who are in the third trimester of pregnancy
(from the 27th gestational week), aged 18-40 years, with regular follow-up with the
obstetrician and who present adequate systemic health during pregnancy, without the need for
absolute rest. In subprojects 1 and 2, pregnant women who tested positive for IgM and IgG
serology will be evaluated. Pregnant women who test positive (n = 60) and pregnant women who
test negative (n = 60) for coronavirus sars-cov-2 will be selected, making a total of 120
pregnant women. In project 1 the sample will be divided into 4 groups of pregnant women: GOC-
with excessive weight gain and with COVID19 (n = 30), GOSC- without excessive weight gain and
COVID19, GNC- without excessive weight gain and with COVID19 (n = 30) and GNSC- without
excessive weight gain and without COVID19 (n = 30). For subproject 2 that will have proteomic
analysis, the number of 10 patients for each group (GOC, GOSC, GNC and GNSC) will be adopted
according to previous protocols for saliva proteomic analysis. Subprojects 3 and 4 will
consist of babies, to identify possible congenital changes during the fetal period. In
subproject 3, the 120 babies of the pregnant women participating in the study will be divided
into BC (n = 60) and BSC (n = 60), which will be evaluated for the occurrence of the
congenital syndrome associated with the presumed maternal infection by coronavirus sars-
cov-2. In project 4, the sample will consist of 20 babies with congenital malformations for
the case group (BM) and 20 control babies without congenital malformations (BSM), exposed to
COVID19.

Not yet recruiting
Exposure During Pregnancy
Corona Virus Infection

Other: congenital malformation

congenital malformation

Eligibility Criteria

Inclusion criteria for pregnant will be in the third trimester of pregnancy (from the 27th
gestational week), aged 18-40 years, with regular follow-up with the obstetrician and who
present adequate systemic health during pregnancy, without the need for absolute rest.

Exclusion Criteria criteria for pregnant will be patients with neuromotor weakness,
hypertension and diabetes mellitus prior to pregnancy, malnutrition (BMI <18.50 kg/m2),
overweight (BMI between 25.00 kg/m2 and 29.99 kg/m2), under antibiotic use or any
medication that may interfere with periodontal condition and users of
alcohol/tobacco/illicit drugs.

Inclusion criteria for babies will be mothers having tested COVID-19 positive and mothers
having tested COVID-19 negative in serological tests, to the BC group and the BSC group,
respectively.

Exclusion criteria for babies will be after measuring the measurements, exams and
eligibility criteria, they are not eligible for coronavirus contamination during the fetal
period.

Eligibility Gender
Female
Eligibility Age
Minimum: 16 Years ~ Maximum: 40 Years
University of Sao Paulo
NCT Number
Keywords
pregnant
Child
Coronavirus Infections
MeSH Terms
Infections
Coronavirus Infections