Clinical trial NCT04647994: Exploratory Study: COVID-19 and Pregnancy
Official title: Exploratory Study in COVID-19 During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Covid19
Keywords: pregnancy
SARS-CoV-2
vertical transmission
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized, in prenatal care, or in delivery time.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic test: SARS-CoV-2 serology
timeFrame: 01/07/2021
Secondary outcomes:
measure: Laboratorial analysis of maternal and umbilical cord blood
timeFrame: 01/07/2021
measure: Laboratorial analysis of Amniotic Fluid
timeFrame: 01/07/2021
measure: Placenta biopsy
timeFrame: 01/07/2021
measure: Laboratorial analysis of colostrum
timeFrame: 01/07/2021
measure: Ovarian remains biopsy
timeFrame: 01/07/2021
measure: Blood count analysis
timeFrame: 01/07/2021
measure: Laboratorial analysis of thyroid hormones
timeFrame: 01/07/2021
measure: PCR analysis
timeFrame: 01/07/2021
measure: Laboratorial analysis of Interleukins
timeFrame: 01/07/2021
measure: Fetal morphology ultrasound
timeFrame: 01/07/2021
measure: Placental insufficiency ultrasound
timeFrame: 01/07/2021
measure: Type of delivery
timeFrame: 01/07/2021
measure: Gestational age at delivery
timeFrame: 01/07/2021
measure: Apgar score
timeFrame: 01/07/2021
measure: Newborn weight
timeFrame: 01/07/2021
measure: Fatigue Scale
timeFrame: 01/07/2021
measure: Prone Position
timeFrame: 01/07/2021
measure: Use of mechanical ventilation
timeFrame: 01/07/2021
measure: Pulmonary Ultrasound
timeFrame: 01/07/2021
measure: Chest Tomography
timeFrame: 01/07/2021
measure: Anxious and depressive symptoms - HAD questionnaire
timeFrame: 01/07/2021
measure: Heart rate variability electrocardiogram
timeFrame: 01/07/2021
measure: Laboratorial analysis of glycated hemoglobin
timeFrame: 01/07/2021
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Rossana P Fracisco
Study officials:
affiliation: Faculdade de Medicina da Universidade de São Paulo - FMUSP
name: Rossana P Francisco, PhD
role: PRINCIPAL_INVESTIGATOR
References: