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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. mai 2022 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

260

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 40 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Annen
  • Tidsperspektiver: Annen

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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
Annen: congenital malformation
congenital malformation
children without congenital malformations
Child without congenital malformations
Annen: congenital malformation
congenital malformation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo

Samarbeidspartnere

Maria Aparecida de Andrade Moreira Machado
Thais Marchini de Oliveira Valarelli

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. desember 2022

Primær fullføring (Forventet)

1. juni 2023

Studiet fullført (Forventet)

1. mai 2024

Datoer for studieregistrering

Først innsendt

20. juli 2020

Først innsendt som oppfylte QC-kriteriene

28. juli 2020

Først lagt ut (Faktiske)

30. juli 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FOBpregnat

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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