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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid-19 HC patients | Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP. |
| |
| Delivery patients | Asymptomatic pregnant women that tested SARS-CoV-2 serology (positive or negative serology) at the delivery time at Universitarian Hospital HU-USP and HC-FMUSP. |
| |
| Prenatal patients | Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2. |
| |
| Negative serology patients | Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 serology | Diagnostic Test | Serology test of SARS-CoV-2 for pregnant women |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic test: SARS-CoV-2 serology | Number of pregnant women with COVID-19 infection assessed with a serology test | 01/07/2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratorial analysis of maternal and umbilical cord blood | Number of participants with transplacental passage of SARS-CoV-2 assessed by laboratorial analysis of maternal and umbilical cord blood | 01/07/2021 |
| Laboratorial analysis of Amniotic Fluid |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized, in prenatal care, or in delivery time.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rossana P Francisco, PhD | Contact | +551126616209 | rossana.francisco@hc.fm.usp.br | |
| Ana Claudia S Farche, PhD | Contact | +551126619280 | anafarche@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Rossana P Francisco, PhD | Faculdade de Medicina da Universidade de São Paulo - FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rossana P Fracisco | Recruiting | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Number of participants with transplacental passage of SARS-CoV-2 assessed by amniotic fluid analysis
| 01/07/2021 |
| Placenta biopsy | Number of participants with transplacental passage of SARS-CoV-2 assessed by placenta biopsy | 01/07/2021 |
| Laboratorial analysis of colostrum | Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum | 01/07/2021 |
| Ovarian remains biopsy | Number of participants with transplacental passage of SARS-CoV-2 assessed by ovarian remains biopsy in cases of abortion and fetal death. | 01/07/2021 |
| Blood count analysis | Number of participants with adverse events assessed by the blood count analysis after SARS-CoV-2 infection. | 01/07/2021 |
| Laboratorial analysis of thyroid hormones | Number of participants with adverse events assessed by the thyroid hormones analysis after SARS-CoV-2 infection. | 01/07/2021 |
| PCR analysis | Number of participants with adverse events assessed by the PCR analysis after SARS-CoV-2 infection. | 01/07/2021 |
| Laboratorial analysis of Interleukins | Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection. | 01/07/2021 |
| Fetal morphology ultrasound | Number of babies with developmental changes and fetal morphology alterations assessed by ultrasound after the maternal diagnosis of Covid-19. | 01/07/2021 |
| Placental insufficiency ultrasound | Number of participants with placental insufficiency and altered fetal well-being assessed by ultrasound after a positive maternal diagnosis of SARS-CoV-2. | 01/07/2021 |
| Type of delivery | Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire. | 01/07/2021 |
| Gestational age at delivery | Gestational age at delivery and premature cases, assessed by a structured questionnaire. | 01/07/2021 |
| Apgar score | 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) | 01/07/2021 |
| Newborn weight | Newborn's weight immediately after birth, assessed by a pediatric weight balance | 01/07/2021 |
| Fatigue Scale | Number of patients with persistent symptoms of fatigue, assessed by a Fatigue Structured Scale | 01/07/2021 |
| Prone Position | Number of patients who needed intervention with a prone position during hospitalization, accessed by the medical record data. | 01/07/2021 |
| Use of mechanical ventilation | Number of patients who needed intervention with a mechanical ventilation and oxygen during hospitalization, accessed by the medical record data. | 01/07/2021 |
| Pulmonary Ultrasound | Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection. | 01/07/2021 |
| Chest Tomography | Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection. | 01/07/2021 |
| Anxious and depressive symptoms - HAD questionnaire | Number of patients with anxious and depressive symptoms in prenatal and postpartum, assessed by Hospital Anxiety and Depression Scale. | 01/07/2021 |
| Heart rate variability electrocardiogram | Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram. | 01/07/2021 |
| Laboratorial analysis of glycated hemoglobin | Number of patients with endocrine system alterations after the Covid-19 infection, assessed by laboratorial analysis of glycated hemoglobin | 01/07/2021 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |