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

NCT04492449 | Unknown DMC

• 1 other identifier: FOBpregnat
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exposure During Pregnancy; Corona Virus Infection

Keywords

pregnant; child; Coronavirus Infections

Outcome Measures

Primary Outcomes (1)

• Periodontal status

  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.

Secondary Outcomes (1)

• Quality of life of pregnants

  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).

Other Outcomes (1)

• Maternal infection

  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.

Study Arms (4)

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

Other: congenital malformation

children without congenital malformations

Child without congenital malformations

Other: congenital malformation

Interventions

congenital malformation OTHER

congenital malformation

children with congenital malformations; children without congenital malformations

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Maria Aparecida de Andrade Moreira Machado: collaborator
• Thais Marchini de Oliveira Valarelli: collaborator

Related Publications (2)

• Liu D, Li L, Wu X, Zheng D, Wang J, Yang L, Zheng C. Pregnancy and Perinatal Outcomes of Women With Coronavirus Disease (COVID-19) Pneumonia: A Preliminary Analysis. AJR Am J Roentgenol. 2020 Jul;215(1):127-132. doi: 10.2214/AJR.20.23072. Epub 2020 Mar 18.

  PMID: 32186894 RESULT

• Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.

  PMID: 26731034 RESULT

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 30, 2020
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: May 1, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share