Exploratory Study: COVID-19 and Pregnancy

Covid19 Clinical Trial

Official title:

Exploratory Study in COVID-19 During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647994
• Other study ID #: 30270820.3.0000.0068
• Status: Recruiting
• Start date: April 11, 2020
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2022
• Source: University of Sao Paulo General Hospital
• Contact: Rossana P Francisco, PhD
• Phone: +551126616209
• Email: rossana.francisco[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 13, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pregnant Women

Intervention

Diagnostic Test:
• SARS-CoV-2 serology
Serology test of SARS-CoV-2 for pregnant women

Locations

Country	Name	City	State
Brazil	Rossana P Fracisco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic test: SARS-CoV-2 serology	Number of pregnant women with COVID-19 infection assessed with a serology test	01/07/2021
Secondary	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
Secondary	Laboratorial analysis of Amniotic Fluid	Number of participants with transplacental passage of SARS-CoV-2 assessed by amniotic fluid analysis	01/07/2021
Secondary	Placenta biopsy	Number of participants with transplacental passage of SARS-CoV-2 assessed by placenta biopsy	01/07/2021
Secondary	Laboratorial analysis of colostrum	Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum	01/07/2021
Secondary	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
Secondary	Blood count analysis	Number of participants with adverse events assessed by the blood count analysis after SARS-CoV-2 infection.	01/07/2021
Secondary	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
Secondary	PCR analysis	Number of participants with adverse events assessed by the PCR analysis after SARS-CoV-2 infection.	01/07/2021
Secondary	Laboratorial analysis of Interleukins	Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection.	01/07/2021
Secondary	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
Secondary	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
Secondary	Type of delivery	Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire.	01/07/2021
Secondary	Gestational age at delivery	Gestational age at delivery and premature cases, assessed by a structured questionnaire.	01/07/2021
Secondary	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
Secondary	Newborn weight	Newborn's weight immediately after birth, assessed by a pediatric weight balance	01/07/2021
Secondary	Fatigue Scale	Number of patients with persistent symptoms of fatigue, assessed by a Fatigue Structured Scale	01/07/2021
Secondary	Prone Position	Number of patients who needed intervention with a prone position during hospitalization, accessed by the medical record data.	01/07/2021
Secondary	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
Secondary	Pulmonary Ultrasound	Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection.	01/07/2021
Secondary	Chest Tomography	Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection.	01/07/2021
Secondary	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
Secondary	Heart rate variability electrocardiogram	Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram.	01/07/2021
Secondary	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