Exploratory Study: COVID-19 and Pregnancy

Exploratory Study in COVID-19 During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Pregnant Women
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 serology

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Rossana P Francisco, PhD; Phone Number: +551126616209; Email: rossana.francisco@hc.fm.usp.br
• Study Contact Backup: Name: Ana Claudia S Farche, PhD; Phone Number: +551126619280; Email: anafarche@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Rossana P Fracisco
    • Contact: Rossana P Francisco, PhD; Phone Number: +551126616209; Email: rossana.francisco@hc.fm.usp.br
    • Contact: Ana CS Farche, PhD; Phone Number: +551126619280; Email: anafarche@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19 HC patients; Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP.	Diagnostic test: SARS-CoV-2 serology; Serology test of SARS-CoV-2 for pregnant women
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.	Diagnostic test: SARS-CoV-2 serology; Serology test of SARS-CoV-2 for pregnant women
Prenatal patients; 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; Serology test of SARS-CoV-2 for pregnant women
Negative serology patients; Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2.	Diagnostic test: SARS-CoV-2 serology; Serology test of SARS-CoV-2 for pregnant women

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Rossana P Francisco, PhD, Faculdade de Medicina da Universidade de São Paulo - FMUSP

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2020
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ANTICIPATED): June 13, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (ACTUAL): December 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; pregnancy; vertical transmission
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 30270820.3.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No