Exploratory Study: COVID-19 and Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Exploratory Study in COVID-19 During Pregnancy

Conditions
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Pregnant Women, Covid19

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2 serology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid-19 HC patients<br>Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP. | Diagnostic Test: SARS-CoV-2 serology<br>* Serology test of SARS-CoV-2 for pregnant women<br>|
| Delivery patients<br>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. | Diagnostic Test: SARS-CoV-2 serology<br>* Serology test of SARS-CoV-2 for pregnant women<br>|
| Prenatal patients<br>Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2. | Diagnostic Test: SARS-CoV-2 serology<br>* Serology test of SARS-CoV-2 for pregnant women<br>|
| Negative serology patients<br>Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2. | Diagnostic Test: SARS-CoV-2 serology<br>* Serology test of SARS-CoV-2 for pregnant women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, SARS-CoV-2, vertical transmission