Effects of COVID-19 on pregnancy, childbirth, puerperium, neonatal period and child development: prospective, multicenter cohort study

Not Applicable

Recruiting

• Conditions: Coronavirus Infections; child development; child care; pregnancy; parturition; pospartum period; newborn; A00-B99

• Registration Number: RBR-65qxs2
• Lead Sponsor: Hospital Universitário de Brasília

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Last Update Posted: 13 November 2023
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Exposed women: Data from the mandatory positive results registration center (Directorate of Epidemiological Surveillance - DIVEP) will be consulted and telephone contact will be made with all women between 18 and 40 years old with a positive test for SARS-CoV-2. For those who report being pregnant, prenatal care will be offered at the University Hospital of Brasília (in an outpatient clinic created specifically for this purpose), as well as childbirth assistance at that hospital. Recruitment will end when it reaches 300 women. Unexposed women: During the months of the study, serology to detect anti-SARS-CoV-2 antibodies (IgG and IgM) and RT-PCR for SARS-CoV2 will be offered to all women admitted for childbirth assistance at the University Hospital of Brasilia. Those with negative tests for COVID 19 and who consent to participate in the study, will be offered Growth and Development monitoring for their children at the Pediatric Service of the Hospital Universitário de Brasília, up to the age of five, in an outpatient clinic created specifically for this purpose . Recruitment will end when reaching n 300 of unexposed women. Exposed newborns: the sample will consist of the children of women infected with SARS-CoV-2 in the different stages of pregnancy, which formed the sample of exposed women. Exposed newborns: group represented by unexposed newborns who are infected in the neonatal period. Upon diagnosis, they will become part of the group of newborns exposed for pediatric follow-up purposes.
Recruitment will end when it reaches n 300 children (newborns and neonates) exposed. Newborns not exposed: the sample will consist of the children of women who made up the group that were not exposed and who remain with negative serology until the end of the neonatal period. Recruitment will end when reaching n 300 unexposed children

Exclusion Criteria

Women exposed and not exposed to SARS-CoV2 infection during pregnancy: pre-existing chronic diseases that require continuous use of medications, except diabetes and hypertension; smoking and / or alcoholism; suspicion or confirmation of other congenital infections such as toxoplasmosis, syphilis, rubella, herpes, Chagas and zika; impossibility of sequential follow-up until delivery. Newborns exposed and not exposed to intrauterine SARS-CoV2 infection: evidence or confirmation of genetic syndromes; suspicion or confirmation of other congenital infections, such as toxoplasmosis, syphilis, rubella, herpes Chagas and zika; impossibility and sequential follow-up until the age of five.

Study & Design

• Study Type: Observational
• Study Design: Not specified