Exploratory Study: COVID-19 and Pregnancy

June 7, 2022 updated by: University of Sao Paulo General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ana Claudia S Farche, PhD
  • Phone Number: +551126619280
  • Email: anafarche@usp.br

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic test: SARS-CoV-2 serology
Time Frame: 01/07/2021
Number of pregnant women with COVID-19 infection assessed with a serology test
01/07/2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laboratorial analysis of maternal and umbilical cord blood
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
Number of participants with transplacental passage of SARS-CoV-2 assessed by amniotic fluid analysis
01/07/2021
Placenta biopsy
Time Frame: 01/07/2021
Number of participants with transplacental passage of SARS-CoV-2 assessed by placenta biopsy
01/07/2021
Laboratorial analysis of colostrum
Time Frame: 01/07/2021
Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum
01/07/2021
Ovarian remains biopsy
Time Frame: 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.
01/07/2021
Blood count analysis
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
Number of participants with adverse events assessed by the thyroid hormones analysis after SARS-CoV-2 infection.
01/07/2021
PCR analysis
Time Frame: 01/07/2021
Number of participants with adverse events assessed by the PCR analysis after SARS-CoV-2 infection.
01/07/2021
Laboratorial analysis of Interleukins
Time Frame: 01/07/2021
Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection.
01/07/2021
Fetal morphology ultrasound
Time Frame: 01/07/2021
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
Time Frame: 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.
01/07/2021
Type of delivery
Time Frame: 01/07/2021
Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire.
01/07/2021
Gestational age at delivery
Time Frame: 01/07/2021
Gestational age at delivery and premature cases, assessed by a structured questionnaire.
01/07/2021
Apgar score
Time Frame: 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)
01/07/2021
Newborn weight
Time Frame: 01/07/2021
Newborn's weight immediately after birth, assessed by a pediatric weight balance
01/07/2021
Fatigue Scale
Time Frame: 01/07/2021
Number of patients with persistent symptoms of fatigue, assessed by a Fatigue Structured Scale
01/07/2021
Prone Position
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection.
01/07/2021
Chest Tomography
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
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
Time Frame: 01/07/2021
Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram.
01/07/2021
Laboratorial analysis of glycated hemoglobin
Time Frame: 01/07/2021
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rossana P Francisco, PhD, Faculdade de Medicina da Universidade de São Paulo - FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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