Covid19, Pregnant Women
Conditions
Keywords
pregnancy, SARS-CoV-2, vertical transmission
Brief summary
The SARS-CoV-2 infection may behave differently in pregnant and postpartum women in the short and long term. Several risk factors or medication use can interfere on disease' evolution and vertical transmission. Thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive SARS-CoV-2.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 serology
Serology test of SARS-CoV-2 for pregnant women
Sponsors
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized or in delivery time; * Asymptomatic pregnant women for SARS-CoV-2 during pregnancy and hospitalized for delivery at HU-USP. * Pregnant women diagnosed with SARS-CoV-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the HU-USP or HCFMUSP.
Exclusion criteria
* Non-confirmation of maternal SARS-CoV-2 infection in pregnant women hospitalized or in delivery time. * Withdrawal of pregnant woman to continue in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic test: SARS-CoV-2 serology | 01/07/2021 | Number of pregnant women with COVID-19 infection assessed with a serology test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratorial analysis of Amniotic Fluid | 01/07/2021 | Number of participants with transplacental passage of SARS-CoV-2 assessed by amniotic fluid analysis |
| Placenta biopsy | 01/07/2021 | Number of participants with transplacental passage of SARS-CoV-2 assessed by placenta biopsy |
| Laboratorial analysis of colostrum | 01/07/2021 | Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum |
| Ovarian remains biopsy | 01/07/2021 | Number of participants with transplacental passage of SARS-CoV-2 assessed by ovarian remains biopsy in cases of abortion and fetal death. |
| Blood count analysis | 01/07/2021 | Number of participants with adverse events assessed by the blood count analysis after SARS-CoV-2 infection. |
| Laboratorial analysis of thyroid hormones | 01/07/2021 | Number of participants with adverse events assessed by the thyroid hormones analysis after SARS-CoV-2 infection. |
| PCR analysis | 01/07/2021 | Number of participants with adverse events assessed by the PCR analysis after SARS-CoV-2 infection. |
| Laboratorial analysis of Interleukins | 01/07/2021 | Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection. |
| Fetal morphology ultrasound | 01/07/2021 | Number of babies with developmental changes and fetal morphology alterations assessed by ultrasound after the maternal diagnosis of Covid-19. |
| Placental insufficiency ultrasound | 01/07/2021 | Number of participants with placental insufficiency and altered fetal well-being assessed by ultrasound after a positive maternal diagnosis of SARS-CoV-2. |
| Type of delivery | 01/07/2021 | Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire. |
| Laboratorial analysis of maternal and umbilical cord blood | 01/07/2021 | Number of participants with transplacental passage of SARS-CoV-2 assessed by laboratorial analysis of maternal and umbilical cord blood |
| Apgar score | 01/07/2021 | Newborn's apgar score at first, second and third minutes after birth, assessed by a Apgar Score Scale (0 = minimum value and 10 = maximum value) |
| Newborn weight | 01/07/2021 | Newborn's weight immediately after birth, assessed by a pediatric weight balance |
| Fatigue Scale | 01/07/2021 | Number of patients with persistent symptoms of fatigue, assessed by a Fatigue Structured Scale |
| Prone Position | 01/07/2021 | Number of patients who needed intervention with a prone position during hospitalization, accessed by the medical record data. |
| Use of mechanical ventilation | 01/07/2021 | Number of patients who needed intervention with a mechanical ventilation and oxygen during hospitalization, accessed by the medical record data. |
| Pulmonary Ultrasound | 01/07/2021 | Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection. |
| Chest Tomography | 01/07/2021 | Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection. |
| Anxious and depressive symptoms - HAD questionnaire | 01/07/2021 | Number of patients with anxious and depressive symptoms in prenatal and postpartum, assessed by Hospital Anxiety and Depression Scale. |
| Heart rate variability electrocardiogram | 01/07/2021 | Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram. |
| Laboratorial analysis of glycated hemoglobin | 01/07/2021 | Number of patients with endocrine system alterations after the Covid-19 infection, assessed by laboratorial analysis of glycated hemoglobin |
| Gestational age at delivery | 01/07/2021 | Gestational age at delivery and premature cases, assessed by a structured questionnaire. |
Countries
Brazil
Contacts
Primary ContactRossana P Francisco, PhD
Backup ContactAna Claudia S Farche, PhD
Outcome results
None listed