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Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to COVID-19 Infection ((COVID-19)

16. maj 2022 opdateret af: Silvia Helena de Carvalho Sales Peres, University of Sao Paulo

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

260

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 40 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Projects: 1. The sample will be 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); 2. The proteomic analysis the sample will be 10 patients for each group (GOC, GOSC, GNC and GNSC); 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 COVID-19 infection; 4. 20 babies with congenital malformations for the case group (BM) and 20 control babies without congenital malformations (BSM), exposed to COVID19.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Andet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Obese pregnants group
Obese pregnants exposure of coronavirus infection.
Normal pregnants group
Normal pregnants exposure of coronavirus infection.
children with congenital malformations
Child with congenital malformations
congenital malformation
children without congenital malformations
Child without congenital malformations
congenital malformation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Periodontal status
Tidsramme: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.
Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.
Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life of pregnants
Tidsramme: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).
Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.
Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal infection
Tidsramme: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.
IgM and IgG serology test for COVID19
Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Forventet)

1. december 2022

Primær færdiggørelse (Forventet)

1. juni 2023

Studieafslutning (Forventet)

1. maj 2024

Datoer for studieregistrering

Først indsendt

20. juli 2020

Først indsendt, der opfyldte QC-kriterier

28. juli 2020

Først opslået (Faktiske)

30. juli 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2022

Sidst verificeret

1. maj 2022

Mere information

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