Exploratory Study: COVID-19 and Pregnancy
- Conditions
- Pregnant WomenCovid19
- Interventions
- Diagnostic Test: SARS-CoV-2 serology
- Registration Number
- NCT04647994
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Covid-19 HC patients SARS-CoV-2 serology Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP. Negative serology patients SARS-CoV-2 serology Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2. Delivery patients SARS-CoV-2 serology 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 SARS-CoV-2 serology Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2.
- Primary Outcome Measures
Name Time Method Diagnostic test: SARS-CoV-2 serology 01/07/2021 Number of pregnant women with COVID-19 infection assessed with a serology test
- Secondary Outcome Measures
Name Time Method 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
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.
Newborn weight 01/07/2021 Newborn's weight immediately after birth, assessed by a pediatric weight balance
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
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.
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.
PCR analysis 01/07/2021 Number of participants with adverse events assessed by the PCR 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.
Gestational age at delivery 01/07/2021 Gestational age at delivery and premature cases, assessed by a structured questionnaire.
Laboratorial analysis of colostrum 01/07/2021 Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum
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.
Type of delivery 01/07/2021 Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire.
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)
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.
Heart rate variability electrocardiogram 01/07/2021 Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram.
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 Interleukins 01/07/2021 Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection.
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.
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
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.
Trial Locations
- Locations (1)
Rossana P Fracisco
🇧🇷São Paulo, Brazil