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

2022년 5월 16일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

관찰

등록 (예상)

260

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 다른
  • 시간 관점: 다른

코호트 및 개입

그룹/코호트
개입 / 치료
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Periodontal status
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Quality of life of pregnants
기간: 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).

기타 결과 측정

결과 측정
측정값 설명
기간
Maternal infection
기간: 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.

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간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2022년 12월 1일

기본 완료 (예상)

2023년 6월 1일

연구 완료 (예상)

2024년 5월 1일

연구 등록 날짜

최초 제출

2020년 7월 20일

QC 기준을 충족하는 최초 제출

2020년 7월 28일

처음 게시됨 (실제)

2020년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 5월 16일

마지막으로 확인됨

2022년 5월 1일

추가 정보

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