Northeast COVID-19 and Pregnancy Study Group (NCOVIP)

Clinical and Laboratory Predictors of COVID-19 Progression and Maternal and Perinatal Outcomes in Infected Pregnant and Postpartum Women in Six Reference Centers in the Northeast of Brazil

A prospective and retrospective cohort study. The objective will to determine the frequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate clinical and laboratory predictors of COVID-19 progression and to determine the factors associated with adverse maternal and perinatal outcomes in healthcare centers in two states of Northeast Brazil.The study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Acute Respiratory Syndrome; Coronavirus Infection; COVID19; Pregnancy Disease

Detailed Description

General Objective: To determine the frequency of COVID-19 in pregnant and postpartum women admitted with flu syndrome, to evaluate the clinical and laboratory predictors of COVID-19 progression and to identify the factors associated with adverse maternal and perinatal / neonatal outcomes in six reference centers in the Northeast of Brazil.

Specific objectives

In pregnant and postpartum women admitted to the four institutions involved with flu-like symptoms or SARS:

1. To describe the biological characteristics (maternal age and pre-pregnancy maternal weight, maternal height, pre-gestational body mass index - BMI and pre-gestational nutritional classification), sociodemographic characteristics (color, number of people living in the household, per capita family income, education, occupation, occupation, marital status, origin and religion), habits (smoking, drinking and use of illicit drugs), obstetric characteristics (number of pregnancies, parity, previous vaginal delivery and previous cesarean, previous abortions, number live children, entry into the study and number of prenatal consultations) and the service of origin (IMIP, HDM, ISEA or MFD);
2. To describe the clinical characteristics (gestational age or postpartum days at the beginning of signs and symptoms, duration of symptoms, isolation, social distance and quarantine before signs and symptoms, need for hospitalization due to infection and / or complications, day of hospitalization due to flu-like syndrome and / or complications, length of hospital stay due to flu-like syndrome and / or complications and the main related signs and symptoms and days of onset - dry or productive cough, runny nose, sore throat, body pain, abdominal pain , chest pain, headache, smell and taste changes, dyspnoea, subfebrile state and fever, diarrhea, asthenia, saturation level, axillary temperature and mild / moderate signs and symptoms);
3. To determine the frequency of COVID-19 infection according to the results of diagnostic tests (rapid test, RT-PCR and serology) applied during hospitalization;
4. To describe the maternal laboratory parameters at the time of the diagnosis of influenza syndrome and the worst laboratory tests (result of RT-PCR for COVID-19, result of viral panel and type of virus, serology for COVID-19 - IgM, IgA and serial IgG, inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor - TNF-α, blood count, coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte sedimentation rate - VSH, C reactive protein - CRP), D-dimer, lactic dehydrogenase - LDH, alkaline phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture, blood gas analysis and day of all tests);
5. To describe the radiological findings (chest X-rays, computed tomography), the pulmonal ultrasonography and day of exam alteration and normalization;
6. To describe the therapeutic modalities performed (oxygen therapy - nasal catheter or Venturi with its maximum flows, use of prone in spontaneous ventilation and / or mechanical ventilation, use of mechanical ventilation, use of neuromuscular blocker, use of extracorporeal membrane oxygenation - ECMO, use of: antibiotics, azithromycin, hydroxychloroquine / chloroquine, antiparasitic drugs such as ivermectin, anticoagulant and / or antiretroviral, pulse therapy, convalescent plasma, need for renal replacement therapy, blood products and others, start day and duration of all therapeutic modalities performed);
7. To describe the characteristics of obstetric ultrasound (tachycardia, frequency of diagnosis of fetal growth restriction, fetus small for gestational age - SGA, changes in amniotic fluid and fetal morphological changes) performed during the course of infection and post-infection follow-up;
8. To describe the doppler velocimetric parameters of the uterine and fetal circulation (pulsatility index of the middle uterine arteries, the middle fetal cerebral artery - MCA, the umbilical artery, the venous duct, the frequency of changes in the doppler velocimetry of all the vessels studied and the speed of the systolic peak in MCA) during infection and in the post-infection follow-up;
9. To describe invasive intrauterine diagnostic procedures (amniocentesis), gestational age at which amniocentesis was performed, indications, results of the RT-PCR test for COVID-19, results of the TORCHS survey, results of the karyotype and results of the inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN- γ, tumor necrosis factor - TNF-α;
10. To determine comorbidities / complications associated with pregnancy or the puerperium (need for hospitalization due to obstetric causes, length of hospital stay, obesity, multiple pregnancy, hypertensive syndromes, diabetes - clinical or gestational, heart disease, chronic obstructive pulmonary disease, bronchial asthma, cerebrovascular disease, renal failure, immunosuppression, severe acute respiratory syndrome - SARS, premature rupture of membranes, premature labor, placenta praevia, urinary tract infection, pneumonia, sepsis, septic shock, abortion, abruptio placenta, postpartum hemorrhage, infection of surgical site, endometritis, peritonitis, thromboembolic events, need for postpartum hysterectomy, need for other surgeries after delivery and tubal ligation, maternal near miss criteria);
11. To describe the delivery outcomes (type of delivery - vaginal, spontaneous or operative, or cesarean section, indication for cesarean section, indication for labor induction, method of labor induction, duration of induction, gestational age at delivery, use of labor analgesia, type of anesthesia for cesarean section);
12. To describe prenatal interventions (antenatal corticosteroid therapy - number of doses, use of magnesium sulfate and prophylactic antibiotic therapy);
13. To describe the final maternal outcome (discharge of the pregnant woman, discharge of the postpartum woman, death of the pregnant woman and death of the postpartum woman);
14. To describe perinatal and neonatal outcomes (fetal death, perinatal death, birth weight, birth weight adequacy - SGA, AGA, LGA, Apgar scores in the first and fifth minutes, need for neonatal resuscitation, ICU admission, need for assisted mechanical ventilation, oxygen therapy, oxygen therapy modalities, hypothermia, hypoglycemia, polycythemia, anemia, neonatal infection, chorioamnionitis, type of respiratory distress, breastfeeding, neonatal congenital infections (TORCHS), congenital malformation, other neonatal morbidities, neonatal near miss, neonatal death, days of life of neonatal death and length of hospital stay and in neonatal ICU);
15. To determine the procedures in neonatal care in the delivery room (cord clamping - early or opportune, skin-to-skin contact, breastfeeding in the delivery room) and, subsequently, rooming-in or admission to a neonatal ICU / nursing unit;
16. To describe the neonatal laboratory parameters of the suspected diagnosis or confirmation of COVID-19 and the worst test results (days of life of the newborn's suspected diagnosis, result of rapid neonate test, RT-PCR for COVID-19 in nasopharyngeal swab , result of viral panel and virus type, serology for COVID-19 - IgM, IgA and IgG serial, inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL -12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor - TNF-α, blood count, coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte sedimentation rate - VSH, C-reactive protein - CRP), D-dimer, lactic dehydrogenase - LDH, alkaline phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture, blood gas analysis and day of all tests);
17. To describe the laboratory parameters in the placenta (result of RT-PCR / viral panel by swab and anatomopathological study) and in cord blood (RT-PCR);
18. To determine the frequency of vertical transmission and the factors associated with a higher risk of its occurrence (gestational age at infection, severity of infection, laboratory markers, type of delivery, labor, cord clamping practice, placental findings, maternal interleukins);
19. To describe the laboratory parameters in breast milk (result of RT-PCR / viral panel);
20. To describe the neonatal imaging exams (chest X-rays, computed tomography and day of exam changes and normalization);
21. To determine the association of biological, sociodemographic, obstetric variables, habits, clinical, maternal laboratory parameters in the diagnosis and the worst result, radiological findings, therapeutic modalities, ultrasound and doppler velocimetric characteristics, invasive procedures, comorbidities / complications and characteristics of childbirth with adverse maternal outcome (maternal near miss and maternal death).
22. To determine the association of biological, sociodemographic, obstetric variables, habits, clinical, maternal laboratory parameters in the diagnosis and the worst result, radiological findings, therapeutic modalities, ultrasound and doppler velocimetric characteristics, invasive procedures, comorbidities / complications, delivery results, prenatal interventions, final pregnancy outcome, delivery room procedures, neonatal care and neonatal laboratory parameters, placenta, amniotic fluid and breast milk with adverse perinatal / neonatal outcome (neonatal near miss and fetal / neonatal death);
23. To analyze maternal and perinatal mortality according to gestational age at the onset of symptoms (Kaplan-Meier survival curve);
24. To compare data from two states in Northeast Brazil with official general data in the country according to the Ministry of Health for the pregnancy-puerperal cycle.
25. In a subset of women routinely assessed on admission through the rapid test (ISEA and Unimed-João Pessoa), to determine the frequency of positive rapid test, positive RT-PCR, associated symptoms, asymptomatic carriers and to compare maternal and perinatal outcomes according to test results.
26. To carry out long-term monitoring of women and babies included in the cohort in 2020, to detect recurrence of symptoms, frequency of reinfection, evolution of laboratory parameters (repetition of RT-PCR and serology) and monitoring of growth and development in the cohort of children aged six months, 12 and 24 months.

Methods: A prospective and retrospective cohort study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution. A database will be created on the RedCap platform. For the association of dependent variables (maternal mortality / near miss and unfavorable perinatal outcomes) with independent variables (biological, sociodemographic characteristics, history, clinical characteristics, ultrasound modifications, doppler velocimetric and laboratory tests, chi-square tests will be used and Fisher's exact, when pertinent, with a significance level of 5%. The relative risk and its 95% confidence interval will also be calculated to determine the strength of association between the variables. outcomes, Student t or Mann-Whitney tests will be adopted. A multivariate analysis will be performed to determine the variables that will actually remain associated, in addition, a Kaplan-Meier survival curve will be constructed.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50.070-550
      • Instituto Materno Infantil Prof. Fernando Figueira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women admitted with flu syndrome in six reference centers in the Northeast of Brazil.

Description

Inclusion Criteria:

• Pregnant or puerperal women;
• Diagnosis of flu syndrome on admission;
• Testing for COVID-19 performed.

Exclusion Criteria:

• Clinical impossibility of signing the Informed Consent Form (ICF), either by the patient or guardian (in the prospective arm);
• Incomplete or not located medical records (retrospective arm).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near miss maternal:	Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.	42 days
Maternal death	It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.	42 days
Near miss neonate	It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.	7 days
Neonatal death	Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.	27 days
Early neonatal death	Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable	7 days
Fetal death	Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.	1 hour
Perinatal death	Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal age	Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.	1 hour
Maternal pre-pregnancy weight	maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.	1 hour
Maternal height	expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.	1 hour
Pre-gestational nutritional classification	classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).	1 hour
Pre-gestational body mass index (BMI)	expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.	1 hour
Maternal color	according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.	1 hour
Number of people living in the household	defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.	1 hour
Family income per capita	collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.	1 hour
Maternal education	as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.	1 hour
Maternal occupation	as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.	1 hour
Maternal occupation with financial income	as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.	1 hour
Maternal marital status	declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.	1 hour
Maternal origin	as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.	1 hour
Maternal religion	according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.	1 hour
Maternal smoking	smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.	1 hour
Maternal alcoholism	habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.	1 hour
Maternal use of illicit drugs	use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.	1 hour
Number of pregnancies	number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.	1 hour
Parity	number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.	1 hour
Number of previous cesarean sections	number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.	1 hour
Number of previous vaginal births	number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.	1 hour
Number of previous abortions	number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.	1 hour
Number of children alive	number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.	1 hour
Number of prenatal consultations	as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.	1 hour
Gestational age of the onset of flu-like signs and symptoms	gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.	1 hour
Number of puerperium days of onset of flu-like signs and symptoms	number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.	14 days
Duration of maternal symptoms	number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.	1 hour
Social isolation during the signs and symptoms of flu-like syndrome	when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.	14 days
Social distance before the signs and symptoms of flu-like syndrome	it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.	1 hour
Quarantine	when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.	14 days
Need for hospitalization due to flu-like syndrome and/or complications	when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.	1 hour
Day of hospitalization due to flu syndrome and/or complications	day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.	1 hour
Length of hospital stay due to flu-like syndrome and/or complications	length of stay, in days, as described in the medical record. Numerical and discrete variable.	14 days
Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months	As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).	24 months
Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months	result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.	24 months
Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel)	result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.	10 days
Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months	result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.	24 months
Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months	result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.	24 months
Serial maternal IgM COVID-19	result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.	6 months, 12 months and 24 months
Serial maternal IgA COVID-19	result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.	6 months, 12 months and 24 months
Serial maternal IgG COVID-19	result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.	6 months, 12 months and 24 months
Serial maternal serology day	rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.	6 months, 12 months and 24 months
Maternal reinfection	after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.	14 days
Cytokines in maternal diagnosis	substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).	14 days
Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19	day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Day of the first blood count from the beginning of the flu syndrome or COVID-19	day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Hemoglobin of maternal diagnosis	value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.	14 days
Leukocytes from maternal diagnosis	value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.	14 days
Deviation to the left of the maternal diagnosis	when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.	14 days
Platelets of maternal diagnosis	value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.	14 days
Typical lymphocytes of maternal diagnosis	value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.	14 days
Atypical lymphocytes of maternal diagnosis	value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.	14 days
Day of the first coagulogram from the beginning of the flu syndrome or COVID-19	day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Maternal diagnosis bleeding time (TB)	value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.	14 days
Maternal diagnosis clotting time (CT)	value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
Maternal prothrombin time of diagnosis (TD)	value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.	14 days
Maternal active partial thromboplastin time of diagnosis (APTT)	value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.	14 days
International normalized ratio (INR)	value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.	14 days
Day of the first urea from the beginning of the flu syndrome or COVID-19	day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Urea from maternal diagnosis	value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.	14 days
Day of the first creatinine from the beginning of the flu syndrome or COVID-19	day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Creatinine of maternal diagnosis	value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.	14 days
Transaminases in maternal diagnosis	defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.	14 days
Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19:	day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
VSH of maternal diagnosis	value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.	14 days
Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19	day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
CRP of maternal diagnosis	value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.	14 days
Day of the first D-dimer from the beginning of the flu syndrome or COVID-19	day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
D-dimer of maternal diagnosis	value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19	day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
DHL of maternal diagnosis	value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.	14 days
Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19	day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Alkaline phosphatase in maternal diagnosis	value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.	14 days
Day of the first troponin from the beginning of the flu syndrome or COVID-19	day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Troponin in maternal diagnosis	value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.	14 days
Day of the first ferritin from the beginning of the flu syndrome or COVID-19	day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Ferritin in maternal diagnosis	alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
Bilirubins in maternal diagnosis	defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.	14 days
Day of the first blood culture from the beginning of the flu syndrome or COVID-19	day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Blood culture of maternal diagnosis	result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	14 days
Blood culture microorganism in maternal diagnosis	name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.	14 days
Day of the first uroculture from the beginning of the flu syndrome or COVID-19	day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Uroculture of maternal diagnosis	result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	14 days
Uroculture microorganism in maternal diagnosis	name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.	14 days
IgM COVID-19 worst maternal result	worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.	5 days
IgA COVID-19 worst maternal result	Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.	5 days
Maternal IgG COVID-19 - worst serial result	worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.	14 days
Cytokines worst maternal outcome	substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).	14 days
Day of the worst urea result from the beginning of the flu syndrome or COVID-19	day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Urea worst maternal result	value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.	14 days
Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19	day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
Creatinine worst maternal result	value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.	14 days
Transaminases worst maternal outcome	defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.	14 days
Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19	day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
VSH worst maternal result	value of the worst result of VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.	14 days
Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19	day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
CRP worst maternal result	value of the worst CRP result measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.	14 days
Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19	day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
D-dimer worst maternal result	value of the worst D-dimer result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19	day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.	14 days
DHL worst maternal result	value of the worst DHL result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.	14 days
Alkaline phosphatase worst maternal result	value of the worst result of alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.	14 days
Troponin worst maternal result	value of the worst result of troponin dosed in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.	14 days
Ferritin worst maternal result	value of the worst result of ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.	14 days
Bilirubins worst maternal result	defined as the worst result of total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.	14 days
Blood culture worst maternal result	result of the worst blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	14 days
Blood culture microorganism worst maternal result	name of the microorganism, which grew on the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.	14 days
Uroculture worse maternal result	result of the worst uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	14 days
Uroculture microorganism worst maternal result	name of the microorganism, which grew in the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.	14 days
Presence of changes in maternal chest radiography	presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.	14 days
Result of maternal chest radiography	description of any radiological alterations, described in a medical report.	14 days
Presence of changes in the mother's chest tomography	presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.	14 days
Day of normalization of the alteration of the tomography of the maternal chest	day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.	14 days
Result of maternal chest tomography	description of any alteration of the tomography described in a medical report.	14 days
Use of maternal nasal catheter	need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.	1 month
Use of maternal Venturi Mask	need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.	1 month
Prone maternal position on spontaneous ventilation	when the patient was placed in prone position on spontaneous ventilation, face down, which was used to improve oxygenation. Yes / No categorical and dichotomous variable.	1 month
Use of therapeutic antibiotics	need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.	14 days
Use of azithromycin	need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of maternal hydroxychloroquine/chloroquine	need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of antiparasitic drugs	need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of anticoagulant	need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of antiretroviral	need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of pulse therapy	need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	14 days
Use of convalescent plasma	need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.	14 days
Assisted Mechanical Ventilation (AMV)	need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.	1 month
Use of neuromuscular blocker	need for medication for neuromuscular block, such as pancuronium, as assessed by the attending physician and described in the medical record. Yes / No categorical and dichotomous variable.	14 days
Use of Extracorporeal Circulation (ECMO)	need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.	1 month
Renal replacement therapy (dialysis)	need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.	1 month
Blood products	need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.	1 month
Other therapeutic modalities	need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.	1 month
Amniotic fluid in the last ultrasound examination	defined by the amniotic fluid index (ILA) or the largest pocket, according to the experience of the ultrasonographer. The ILA will be measured in cm, being defined as the sum of the largest pockets of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 8.0 and 18.0cm), decreased (between 7.9 and 5.0cm), moderate oligohydramnios (between 4.9 and 3.0cm), severe oligohydramnios (<3 , 0cm), increased (between 18.1 and 24cm) and polyhydramnios (ILA> 24cm) (81.82). The largest pocket will also be measured in cm, being defined as the measure of the largest pocket of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 3.0 and 8.0cm), decreased (between 2.9 and 2.0cm), moderate oligoamine (between 1.9 and 1.0cm), severe oligoamine (<1.0cm), increased (ILA between 8.1 and 12.0cm) and polyhydramnios (ILA> 12.0cm).	14 days
Fetal growth restriction	defined by the Delphi procedure 2016 . Yes / No categorical and dichotomous variable.	14 days
Small fetus for gestational age (SGA)	defined when the estimated fetal weight is <10pct for gestational age and does not meet the criteria for IUGR. Yes / No categorical and dichotomous variable.	14 days
Presence of fetal morphological changes	presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.	1 month
Fetal morphological changes	description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.	1 month
Frequency of fetal tachycardia (FFT)	increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.	1 month
Doppler velocimetry parameters in the last ultrasound examination	from the pulsatility index (PI), which is automatically calculated by the ultrasound device, using the formula: systolic peak minus the diastolic peak divided by the average speed.	1 month
Gestational age of amniocentesis	gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.	1 month
Amniocentesis indications	indication for amniocentesis, due to COVID-19 or another cause.	1 month
Result of amniocentesis for COVID19	result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.	1 month
Amniocentesis cytokines	substances capable of modulating the cellular response of several cells, such as interleukins IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in amniotic fluid, in pg / ml, from the beginning of the flu syndrome or COVID-19 , and in the period of the syndrome. Numeric and continuous variable (for each cytokine).	1 month
Need for hospitalization due to obstetric causes	need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.	1 month
Maternal hospital stay	total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.	1 month
Obesity	calculated based on the last BMI (weight [kg] / height [m] 2), by gestational age, using the curve by Atalah et al. Yes / No categorical and dichotomous variable.	1 month
Chronic arterial hypertension (CAH)	defined as blood pressure (BP) greater than or equal to 140 / 90mmHg, diagnosed before pregnancy, or before the 20th week of pregnancy . Yes / No categorical and dichotomous variable.	1 month
Superimposed preeclampsia	defined as CAH associated with signs of severity . Yes / No categorical and dichotomous variable.	1 month
Gestational hypertension	defined as BP greater than or equal to 140 / 90mmHg, diagnosed above the 20th week of pregnancy, with no signs of severity or proteinuria . Yes / No categorical and dichotomous variable.	1 month
Pre-eclampsia	defined as BP greater than or equal to 140 / 90mmHg, above the 20th week of pregnancy, associated with proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3 ), or target organ dysfunction, which can be categorized as severe and non-severe . Yes / No categorical and dichotomous variable.	1 month
Eclampsia	defined as BP greater than or equal to 140 / 90mmHg above the 20th week of gestation, in the presence of proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3), associated with seizures. Yes / No categorical and dichotomous variable.	1 month
HELLP syndrome	defined by the presence of hemolysis, elevated liver enzymes, decreased platelets (below 100,000 / L), elevated TGO / TGP (above 70UI / L) . Yes / No categorical and dichotomous variable.	1 month
Clinical diabetes	defined by the presence of one of the criteria: HbA1C ≥ 6.5% or fasting blood glucose ≥ 126mg / dl - the test should be repeated - or random blood glucose> 200mg / dl, associated with symptoms of diabetes , depending on diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.	1 month
Gestational diabetes	defined by the presence of at least one of the criteria after an oral glucose tolerance test (TOTG) performed between the 24th and 28th weeks of gestation: fasting glucose ≥ 92mg / dl, or ≥ 180mg / dl (after one hour), or ≥ 153mg / dl (after two hours) , according to the diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.	1 month
Premature rupture of membranes	spontaneous rupture of the membranes, diagnosed by anamnesis and clinical examination of the pregnant woman, before the start of labor. Yes / No categorical and dichotomous variable.	1 month
Premature labor	defined as the spontaneous triggering of labor before term (<37 weeks), when there were above three contractions in 30 minutes and cervical alteration, according to clinical and obstetric evaluation. Yes / No categorical and dichotomous variable.	1 month
Placenta previa	define when the placental insertion is low, close to the cervix, regardless of its classification (total, partial and marginal), according to ultrasound report. Yes / No categorical and dichotomous variable.	1 month
Abortion	termination of pregnancy before the 22nd week and / or below 500 g, gestational age preferable, provided it is reliable, regardless of whether it is spontaneous or provoked. Yes / No categorical and dichotomous variable.	1 month
Normally inserted placental abruption	defined as vaginal bleeding and / or uterine hypertonia, leading to emergency delivery, with evidence of retroplacental hematoma in the postpartum period. Yes / No categorical and dichotomous variable.	1 month
Maternal urinary tract infection	defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.	1 month
Maternal heart disease	presence of any congenital or acquired maternal heart disease, according to the patient's information, or diagnosed during hospitalization. Yes / No categorical and dichotomous variable.	1 month
Bronchial asthma	as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.	1 month
Chronic obstructive pulmonary disease (COPD)	as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.	1 month
Cerebrovascular disease	as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.	1 month
Chronic kidney injury	as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.	1 month
Immunosuppression	as reported by the patient and / or described in the chart that presents the diagnosis of immunosuppressive disease or use immunosuppressive medication. Categorical and dichotomous Yes / No type.	1 month
Maternal pneumonia	presence of the flu syndrome associated with laboratory changes, such as leukocytosis or leukopenia, and radiological, such as localized or diffuse interstitial infiltrate, or presence of a condensation area, as diagnosed by the attending physician. Yes / No categorical and dichotomous variable.	1 month
Maternal sepsis	life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.	1 month
Septic shock	defined as a situation of sepsis, associated with signs of hypoperfusion, with fluid-refractory hypotension and requiring vasopressor therapy (Lactate> 2 mmol / L). Yes / No categorical and dichotomous variable.	1 month
Severe acute respiratory syndrome (SARS)	flu-like syndrome (fever, cough, dyspnoea and other nonspecific), accompanied by oxygen saturation <95% (SatO2), respiratory distress or tachypnea, hypotension and worsening of the clinical conditions of the underlying disease. Yes / No categorical and dichotomous variable.	1 month
Postpartum hemorrhage	increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.	14 days
Infection of the operative site	exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.	14 days
Endometritis	characterized by the discharge of purulent secretion from the uterine cervix, remaining dilated, with an unpleasant odor and fever for a minimum of two consecutive days, excluding the first 24 hours, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.	14 days
Peritonitis	characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.	14 days
Need for postpartum hysterectomy	removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.	1 month
Type of delivery	defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.	1 hour
Indication of cesarean section	if a cesarean section was performed, insert the indication that the attending physicians described, which can be later modified, according to the medical record evaluation by the researchers. The main indications are: dystocias, including cephalopelvic disproportion, macrosomia, impaired fetal vitality, placenta previa, cord prolapse, placental abruption, among others.	1 hour
Gestational age at birth	gestational age at birth, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the amniocentesis. Numerical and discrete variable.	1 hour
Use of labor analgesia	use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.	4 hours
Type of anesthesia for cesarean section	method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.	1 hour
Antenatal corticosteroid therapy (pulmonary maturity)	as noted in the medical records, referring to the complete course of betamethasone (12mg two doses in a 24h interval) or dexamethasone (6mg 12 / 12h, for two days), incomplete course, not taking corticosteroids or without indication for accelerating fetal lung maturity.	14 days
Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia)	as noted in the medical record, magnesium sulphate for neuroprotection, before delivery and until the 32nd week of pregnancy, being categorized as complete course (performance of attack and first stage of magnesium sulfate before delivery), incomplete, not performed or without indication.	32 weeks
Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis)	as noted in the medical records, referring to the use of the prophylactic regimen of crystalline penicillin to prevent neonatal infection with group B Streptococcus, being categorized as complete (completion of at least two phases) crystalline penicillin before delivery), incomplete, not performed or without indication.	14 days
Hospital discharge when pregnant	when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.	1 month
Hospital discharge when puerperal	when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.	1 month
Maternal death when pregnant	when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.	1 month
Maternal death when puerperal	when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.	45 days
Fetal death	birth of a fetus without vitality. Yes / No categorical and dichotomous variable.	10 hours
Perinatal death	fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.	27 days
Birth weight	as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.	1 hour
Adequacy of birth weight	classification of birth weight, according to gestational age, being categorized as: small for gestational age (SGA), when <10th pct; suitable for gestational age (AGA), when between 10º pct and 90º pct; and great for gestational age (GIG), when> 90º pct.	1 hour
Apgar scores in the first minute	as calculated by the classic Apgar score , in the first minute of birth, recorded in medical records, which can be later categorized. Numerical and discrete.	1 minute
Apgar scores in the fifth minute	as calculated by the classic Apgar score, in the fifth minute of birth, recorded in medical records, which can be further categorized. Numerical and discrete variable.	5 minutes
Neonatal ICU admission	defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.	1 hour
Need for neonatal resuscitation	defined as the need for resuscitation maneuvers, performed on the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.	27 days
Need for neonatal mechanical ventilation	defined as the need for assisted mechanical ventilation, provided to the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.	27 days
Neonatal nasal catheter	need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.	27 days
Neonatal Continuous Positive Airway Pressure (CPAP) mask	need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.	27 days
Neonatal hypothermia	defined when the axillary temperature is less than or equal to 35ºC, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.	27 days
Neonatal hypoglycemia	defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.	27 days
Neonatal infection	defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.	27 days
Chorioamnionitis	defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.	27 days
Neonatal respiratory distress modality	defined as newborn's respiratory distress (RDS), transient tachypnea of the newborn (NRT) or absent respiratory distress, as noted in the medical record for neonatal care.	1 month
Neonatal congenital infection (TORCHS)	defined as any congenital infection confirmed at birth, based on fetal PCR, neonatal examination or maternal serology, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.	1 month
Congenital malformation	defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.	1 month
Breastfeeding	exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.	1 month
Cord ligation	can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.	10 minutes
Skin-to-skin contact	as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.	1 hour
Breastfeeding in the delivery room	according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.	1 hour
Days of life of the newborn's diagnostic suspicion	days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.	1 month
Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months	result of RT-PCR in the diagnosis of COVID-19, through the blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.	6 months, 12 months and 24 months
Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel)	result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.	6 months, 12 months and 24 months
Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months	result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.	6 months, 12 months and 24 months
Neonatal cytokines	substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine)	6 months, 12 months and 24 months
Neonatal IgM COVID-19	result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according with the reference values of each serological kit, performed after the 5th day of signs and symptoms.	5 days
IgA COVID-19 neonatal serial	result of IgA COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.	5 days
Serial neonatal IgG COVID-19	result of IgG COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 14th day of signs and symptoms. Numeric and continuous variable.	14 days
Neonatal reinfection	after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.	14 days
Hemoglobin from neonatal diagnosis	value of the first hemoglobin measured in neonatal blood, in g / dL, from the suspicion of the diagnosis by COVID-19. Numeric and continuous variable.	14 days
Diagnostic neonatal bleeding time (BT)	value of the first BT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Diagnostic neonatal clotting time (CT)	value of the first CT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Urea from neonatal diagnosis	value of the first urea measured in neonatal blood, in mg / dL, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Creatinine from neonatal diagnosis	value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.	1 month
Transaminases of the neonatal diagnosis	defined as aspartate aminotransferase or glutamic-oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase, based on the suspicion of the diagnosis by COVID-19.	1 month
Blood culture of the neonatal diagnosis	result of the first blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	1 month
Uroculture of neonatal diagnosis	result of the first urine culture, based on the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	1 month
IgM COVID-19 - worst neonatal result	worst result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate , according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.	5 days
Neonatal IgG COVID-19 - worst serial result	worst result of IgG COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 14th day of signs and symptoms. Numeric and continuous variable.	14 days
Cytokines - worst neonatal result	worst result of cytokines, substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12 , IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from suspected diagnosis. Numeric and continuous variable (for each cytokine).	14 days
Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19	day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19	day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Bleeding time - worst neonatal result (BT)	value of the worst BT result measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Urea - worst neonatal result	value of the worst result of urea measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Creatinine - worst neonatal result	value of the worst result of creatinine measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.	1 month
Transaminases - worst neonatal result	defined as the worst result of aspartate aminotransferase (AST) or glutamic oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase measurements, from the beginning of suspected COVID-19 diagnosis.	1 month
Blood culture - worst neonatal result	result of the worst blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	1 month
Uroculture - worst neonatal result	result of the worst urine culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.	1 month
Gasometry - worst neonatal result	defined as the worst result of measuring hydrogen potential, excess of bases, bicarbonate, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2) and oxygenation index, in neonatal arterial blood, from the beginning of suspected COVID-19 diagnosis.	1 hour
Result of RT-PCR of the placenta	result of RT-PCR in the diagnosis of COVID-19, through the placenta, according to the usual technique, being categorized as positive, negative and indeterminate.	1 month
Placental viral panel	result of the RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through the placenta, according to the technique and kit used, categorized according to the virus found.	1 month
Histopathological of the placenta	result of the histopathological of the placenta, according to the usual technique.	1 month
Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge	result of RT-PCR in the diagnosis of COVID-19, using breast milk, according to the usual technique, being categorized as positive, negative and indeterminate.	1 month
Viral panel in breast milk	result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through breast milk, according to the technique and kit used, categorized according to the virus found.	1 month
Presence of alteration of the neonatal chest radiography	presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.	1 day
Result of neonatal chest radiography	description of any radiological changes, according to a medical report.	1 day
Presence of alteration of the neonatal chest tomography	presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.	1 day
Result of neonatal chest tomography	description of any alteration of the tomography, according to a medical report.	1 day
Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference	measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.	6, 12 and 24 months
Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight	measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.	6, 12 and 24 months
Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height	measured by the assistant pediatrician as noted on the prenatal card, in cm. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.	6, 12 and 24 months
Development of the newborn up to 6 months	as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as adequate, when all are present, and inappropriate, if any of the situations is absent: the baby is firmer and already sits with support; he turns around and rolls from side to side; grabs toys like rings and rattles, holding tight and resisting if someone tries to take them out of your hand; and when he hears some noise, he turns his head to find where it comes from.	6 months
Development of the newborn up to 12 months	as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inappropriate, if any of the situations is absent: the baby can stand up, leaning on furniture or with the help of a person; clap your hands, you can point with your finger what you want to catch and have fun saying goodbye; and you may be speaking a word or two like mom, pope, give.	12 months
Development of the newborn up to 24 months	as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inadequate, if any of the situations is absent: start to put two words together and speak simple phrases like "where's the cat?" or "milk not"; he demonstrates his own will, tests limits and speaks the word "no" a lot; climbs on chairs and sofas. Run, go up and down stairs, standing, with the help of an adult; can help to dress; and you can start to learn how to control pee and poop.	24 months

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Investigators: Principal Investigator: LEILA KATZ, MD, PhD, Instituto Materno Infantil Prof. Fernando Figueira

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; pregnancy; coronavirus; perinatal mortality; coronavirus infection; severe acute respiratory syndrome; maternal mortality; coronavirus 2; SRAS-CoV-2
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections
• Other Study ID Numbers: NCOVIP

Drug and device information, study documents

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