Pregnant WomenNCT04647994
Exploratory Study: COVID-19 and Pregnancy
An observational study of Pregnant Women and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Covid19
- What is being tested?
- SARS-CoV-2 serology
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Apr 2020to 13 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized, in prenatal care, or in delivery time.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rossana P Fracisco
São Paulo, 05403000
Rossana P Francisco, PhD, +551126616209, rossana.francisco@hc.fm.usp.br
Ana CS Farche, PhD, +551126619280, anafarche@usp.br
About this study
Official title: 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.
- Conditions
- Pregnant Women, Covid19
- Being tested
- SARS-CoV-2 serology
- Keywords
- pregnancy, SARS-CoV-2, vertical transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 serologyDiagnostic test
Serology test of SARS-CoV-2 for pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 HC patients | Pregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP. Receives: Diagnostic Test: SARS-CoV-2 serology | |
| 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. Receives: Diagnostic Test: SARS-CoV-2 serology | |
| Prenatal patients | Pregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2. Receives: Diagnostic Test: SARS-CoV-2 serology | |
| Negative serology patients | Pregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2. Receives: Diagnostic Test: SARS-CoV-2 serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic test: SARS-CoV-2 serology
Number of pregnant women with COVID-19 infection assessed with a serology test
Measured: 01/07/2021
Secondary outcomes (23)
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
Measured: 01/07/2021
Laboratorial analysis of Amniotic Fluid
Number of participants with transplacental passage of SARS-CoV-2 assessed by amniotic fluid analysis
Measured: 01/07/2021
Placenta biopsy
Number of participants with transplacental passage of SARS-CoV-2 assessed by placenta biopsy
Measured: 01/07/2021
Laboratorial analysis of colostrum
Number of participants with transplacental passage of SARS-CoV-2 assessed by colostrum
Measured: 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.
Measured: 01/07/2021
Blood count analysis
Number of participants with adverse events assessed by the blood count analysis after SARS-CoV-2 infection.
Measured: 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.
Measured: 01/07/2021
PCR analysis
Number of participants with adverse events assessed by the PCR analysis after SARS-CoV-2 infection.
Measured: 01/07/2021
Laboratorial analysis of Interleukins
Number of participants with adverse events assessed by the interleukins analysis after SARS-CoV-2 infection.
Measured: 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.
Measured: 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.
Measured: 01/07/2021
Type of delivery
Number of patients that performed natural delivery or caesarean, assessed by a structured questionnaire.
Measured: 01/07/2021
Gestational age at delivery
Gestational age at delivery and premature cases, assessed by a structured questionnaire.
Measured: 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)
Measured: 01/07/2021
Newborn weight
Newborn's weight immediately after birth, assessed by a pediatric weight balance
Measured: 01/07/2021
Fatigue Scale
Number of patients with persistent symptoms of fatigue, assessed by a Fatigue Structured Scale
Measured: 01/07/2021
Prone Position
Number of patients who needed intervention with a prone position during hospitalization, accessed by the medical record data.
Measured: 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.
Measured: 01/07/2021
Pulmonary Ultrasound
Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection.
Measured: 01/07/2021
Chest Tomography
Number of patients with alterations in pulmonary ultrasound and chest tomography resulting from SARS-Cov2 infection.
Measured: 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.
Measured: 01/07/2021
Heart rate variability electrocardiogram
Number of patients with cardiac autonomic modulation, assessed by a heart rate variability electrocardiogram.
Measured: 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
Measured: 01/07/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start11 Apr 2020
- Primary completion1 Jun 2022
- Study completion13 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rossana P Francisco, PhD, Principal investigator, Faculdade de Medicina da Universidade de São Paulo - FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647994
- Sponsor's protocol ID
- 30270820.3.0000.0068
- Status last verified
- Jun 2022
- First submitted
- 23 Nov 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study in COVID-19 During Pregnancy
- ClinicalTrials.gov ID
- NCT04647994
- Acronym / sponsor ID
- 30270820.3.0000.0068
- Conditions
- Pregnant Women, Covid19
- Keywords
- pregnancy, SARS-CoV-2, vertical transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Covid-19 HC patients | – | Diagnostic Test: SARS-CoV-2 serologyPregnant women hospitalized with symptoms and diagnosis of SARS-CoV-2 at HC-FMUSP. |
| Delivery patients | – | Diagnostic Test: SARS-CoV-2 serologyAsymptomatic 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 | – | Diagnostic Test: SARS-CoV-2 serologyPregnant women that performs prenatal care in Universitarian Hospital HU-USP or HC-FMUSP with diagnosis of SARS-CoV-2. |
| Negative serology patients | – | Diagnostic Test: SARS-CoV-2 serologyPregnant women that performs prenatal care with symptoms and tested serology/swab negative for SARS-CoV-2. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized, in prenatal care, or in delivery time.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 serologySerology test of SARS-CoV-2 for pregnant women | Diagnostic test | Covid-19 HC patients, Delivery patients, Negative serology patients, Prenatal patients |
Primary outcome
Diagnostic test: SARS-CoV-2 serology
Time frame: 01/07/2021
Number of pregnant women with COVID-19 infection assessed with a serology test
23 secondary outcomes
Laboratorial analysis of maternal and umbilical cord blood
Time frame: 01/07/2021
Laboratorial analysis of Amniotic Fluid
Time frame: 01/07/2021
Placenta biopsy
Time frame: 01/07/2021
Laboratorial analysis of colostrum
Time frame: 01/07/2021
Ovarian remains biopsy
Time frame: 01/07/2021
Blood count analysis
Time frame: 01/07/2021
Laboratorial analysis of thyroid hormones
Time frame: 01/07/2021
PCR analysis
Time frame: 01/07/2021
Laboratorial analysis of Interleukins
Time frame: 01/07/2021
Fetal morphology ultrasound
Time frame: 01/07/2021
Placental insufficiency ultrasound
Time frame: 01/07/2021
Type of delivery
Time frame: 01/07/2021
Gestational age at delivery
Time frame: 01/07/2021
Apgar score
Time frame: 01/07/2021
Newborn weight
Time frame: 01/07/2021
Fatigue Scale
Time frame: 01/07/2021
Prone Position
Time frame: 01/07/2021
Use of mechanical ventilation
Time frame: 01/07/2021
Pulmonary Ultrasound
Time frame: 01/07/2021
Chest Tomography
Time frame: 01/07/2021
Anxious and depressive symptoms - HAD questionnaire
Time frame: 01/07/2021
Heart rate variability electrocardiogram
Time frame: 01/07/2021
Laboratorial analysis of glycated hemoglobin
Time frame: 01/07/2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rossana P Francisco, PhD principal investigator
Faculdade de Medicina da Universidade de São Paulo - FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossana P Francisco, PhD (+551126616209, rossana.francisco@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic test: SARS-CoV-2 serology (time frame: 01/07/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.