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Northeast COVID-19 and Pregnancy Study Group (NCOVIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462367
Recruitment Status : Not yet recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

Brief Summary:
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.

Condition or disease
COVID19 Coronavirus Infection Pregnancy Disease Severe Acute Respiratory Syndrome

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Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Near miss maternal: [ Time Frame: 42 days ]
    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.

  2. Maternal death [ Time Frame: 42 days ]
    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.

  3. Near miss neonate [ Time Frame: 7 days ]
    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.

  4. Neonatal death [ Time Frame: 27 days ]
    Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.

  5. Early neonatal death [ Time Frame: 7 days ]
    Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable

  6. Fetal death [ Time Frame: 1 hour ]
    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.

  7. Perinatal death [ Time Frame: 7 days ]
    Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.


Secondary Outcome Measures :
  1. Maternal age [ Time Frame: 1 hour ]
    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.

  2. Maternal pre-pregnancy weight [ Time Frame: 1 hour ]
    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.

  3. Maternal height [ Time Frame: 1 hour ]
    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.

  4. Pre-gestational nutritional classification [ Time Frame: 1 hour ]
    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).

  5. Pre-gestational body mass index (BMI) [ Time Frame: 1 hour ]
    expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.

  6. Maternal color [ Time Frame: 1 hour ]
    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.

  7. Number of people living in the household [ Time Frame: 1 hour ]
    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.

  8. Family income per capita [ Time Frame: 1 hour ]
    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.

  9. Maternal education [ Time Frame: 1 hour ]
    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.

  10. Maternal occupation [ Time Frame: 1 hour ]
    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.

  11. Maternal occupation with financial income [ Time Frame: 1 hour ]
    as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.

  12. Maternal marital status [ Time Frame: 1 hour ]
    declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.

  13. Maternal origin [ Time Frame: 1 hour ]
    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.

  14. Maternal religion [ Time Frame: 1 hour ]
    according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.

  15. Maternal smoking [ Time Frame: 1 hour ]
    smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

  16. Maternal alcoholism [ Time Frame: 1 hour ]
    habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

  17. Maternal use of illicit drugs [ Time Frame: 1 hour ]
    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.

  18. Number of pregnancies [ Time Frame: 1 hour ]
    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.

  19. Parity [ Time Frame: 1 hour ]
    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.

  20. Number of previous cesarean sections [ Time Frame: 1 hour ]
    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.

  21. Number of previous vaginal births [ Time Frame: 1 hour ]
    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.

  22. Number of previous abortions [ Time Frame: 1 hour ]
    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.

  23. Number of children alive [ Time Frame: 1 hour ]
    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.

  24. Number of prenatal consultations [ Time Frame: 1 hour ]
    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.

  25. Gestational age of the onset of flu-like signs and symptoms [ Time Frame: 1 hour ]
    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.

  26. Number of puerperium days of onset of flu-like signs and symptoms [ Time Frame: 14 days ]
    number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.

  27. Duration of maternal symptoms [ Time Frame: 1 hour ]
    number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.

  28. Social isolation during the signs and symptoms of flu-like syndrome [ Time Frame: 14 days ]
    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.

  29. Social distance before the signs and symptoms of flu-like syndrome [ Time Frame: 1 hour ]
    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.

  30. Quarantine [ Time Frame: 14 days ]
    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.

  31. Need for hospitalization due to flu-like syndrome and/or complications [ Time Frame: 1 hour ]
    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.

  32. Day of hospitalization due to flu syndrome and/or complications [ Time Frame: 1 hour ]
    day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.

  33. Length of hospital stay due to flu-like syndrome and/or complications [ Time Frame: 14 days ]
    length of stay, in days, as described in the medical record. Numerical and discrete variable.

  34. Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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).

  35. Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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.

  36. Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel) [ Time Frame: 10 days ]
    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.

  37. Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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.

  38. Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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.

  39. Serial maternal IgM COVID-19 [ Time Frame: 6 months, 12 months and 24 months ]
    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.

  40. Serial maternal IgA COVID-19 [ Time Frame: 6 months, 12 months and 24 months ]
    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.

  41. Serial maternal IgG COVID-19 [ Time Frame: 6 months, 12 months and 24 months ]
    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.

  42. Serial maternal serology day [ Time Frame: 6 months, 12 months and 24 months ]
    rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.

  43. Maternal reinfection [ Time Frame: 14 days ]
    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.

  44. Cytokines in maternal diagnosis [ Time Frame: 14 days ]
    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).

  45. Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  46. Day of the first blood count from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  47. Hemoglobin of maternal diagnosis [ Time Frame: 14 days ]
    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.

  48. Leukocytes from maternal diagnosis [ Time Frame: 14 days ]
    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.

  49. Deviation to the left of the maternal diagnosis [ Time Frame: 14 days ]
    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.

  50. Platelets of maternal diagnosis [ Time Frame: 14 days ]
    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.

  51. Typical lymphocytes of maternal diagnosis [ Time Frame: 14 days ]
    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.

  52. Atypical lymphocytes of maternal diagnosis [ Time Frame: 14 days ]
    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.

  53. Day of the first coagulogram from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  54. Maternal diagnosis bleeding time (TB) [ Time Frame: 14 days ]
    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.

  55. Maternal diagnosis clotting time (CT) [ Time Frame: 14 days ]
    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.

  56. Maternal prothrombin time of diagnosis (TD) [ Time Frame: 14 days ]
    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.

  57. Maternal active partial thromboplastin time of diagnosis (APTT) [ Time Frame: 14 days ]
    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.

  58. International normalized ratio (INR) [ Time Frame: 14 days ]
    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.

  59. Day of the first urea from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  60. Urea from maternal diagnosis [ Time Frame: 14 days ]
    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.

  61. Day of the first creatinine from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  62. Creatinine of maternal diagnosis [ Time Frame: 14 days ]
    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.

  63. Transaminases in maternal diagnosis [ Time Frame: 14 days ]
    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.

  64. Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19: [ Time Frame: 14 days ]
    day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  65. VSH of maternal diagnosis [ Time Frame: 14 days ]
    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.

  66. Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  67. CRP of maternal diagnosis [ Time Frame: 14 days ]
    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.

  68. Day of the first D-dimer from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  69. D-dimer of maternal diagnosis [ Time Frame: 14 days ]
    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.

  70. Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  71. DHL of maternal diagnosis [ Time Frame: 14 days ]
    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.

  72. Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  73. Alkaline phosphatase in maternal diagnosis [ Time Frame: 14 days ]
    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.

  74. Day of the first troponin from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  75. Troponin in maternal diagnosis [ Time Frame: 14 days ]
    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.

  76. Day of the first ferritin from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  77. Ferritin in maternal diagnosis [ Time Frame: 14 days ]
    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.

  78. Bilirubins in maternal diagnosis [ Time Frame: 14 days ]
    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.

  79. Day of the first blood culture from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  80. Blood culture of maternal diagnosis [ Time Frame: 14 days ]
    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.

  81. Blood culture microorganism in maternal diagnosis [ Time Frame: 14 days ]
    name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

  82. Day of the first uroculture from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  83. Uroculture of maternal diagnosis [ Time Frame: 14 days ]
    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.

  84. Uroculture microorganism in maternal diagnosis [ Time Frame: 14 days ]
    name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

  85. IgM COVID-19 worst maternal result [ Time Frame: 5 days ]
    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.

  86. IgA COVID-19 worst maternal result [ Time Frame: 5 days ]
    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.

  87. Maternal IgG COVID-19 - worst serial result [ Time Frame: 14 days ]
    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.

  88. Cytokines worst maternal outcome [ Time Frame: 14 days ]
    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).

  89. Day of the worst urea result from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  90. Urea worst maternal result [ Time Frame: 14 days ]
    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.

  91. Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  92. Creatinine worst maternal result [ Time Frame: 14 days ]
    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.

  93. Transaminases worst maternal outcome [ Time Frame: 14 days ]
    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.

  94. Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

  95. VSH worst maternal result [ Time Frame: 14 days ]
    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.

  96. Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  97. CRP worst maternal result [ Time Frame: 14 days ]
    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.

  98. Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  99. D-dimer worst maternal result [ Time Frame: 14 days ]
    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.

  100. Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19 [ Time Frame: 14 days ]
    day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

  101. DHL worst maternal result [ Time Frame: 14 days ]
    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.

  102. Alkaline phosphatase worst maternal result [ Time Frame: 14 days ]
    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.

  103. Troponin worst maternal result [ Time Frame: 14 days ]
    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.

  104. Ferritin worst maternal result [ Time Frame: 14 days ]
    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.

  105. Bilirubins worst maternal result [ Time Frame: 14 days ]
    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.

  106. Blood culture worst maternal result [ Time Frame: 14 days ]
    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.

  107. Blood culture microorganism worst maternal result [ Time Frame: 14 days ]
    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.

  108. Uroculture worse maternal result [ Time Frame: 14 days ]
    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.

  109. Uroculture microorganism worst maternal result [ Time Frame: 14 days ]
    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.

  110. Presence of changes in maternal chest radiography [ Time Frame: 14 days ]
    presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.

  111. Result of maternal chest radiography [ Time Frame: 14 days ]
    description of any radiological alterations, described in a medical report.

  112. Presence of changes in the mother's chest tomography [ Time Frame: 14 days ]
    presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.

  113. Day of normalization of the alteration of the tomography of the maternal chest [ Time Frame: 14 days ]
    day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.

  114. Result of maternal chest tomography [ Time Frame: 14 days ]
    description of any alteration of the tomography described in a medical report.

  115. Use of maternal nasal catheter [ Time Frame: 1 month ]
    need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

  116. Use of maternal Venturi Mask [ Time Frame: 1 month ]
    need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

  117. Prone maternal position on spontaneous ventilation [ Time Frame: 1 month ]
    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.

  118. Use of therapeutic antibiotics [ Time Frame: 14 days ]
    need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.

  119. Use of azithromycin [ Time Frame: 14 days ]
    need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  120. Use of maternal hydroxychloroquine/chloroquine [ Time Frame: 14 days ]
    need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  121. Use of antiparasitic drugs [ Time Frame: 14 days ]
    need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  122. Use of anticoagulant [ Time Frame: 14 days ]
    need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  123. Use of antiretroviral [ Time Frame: 14 days ]
    need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  124. Use of pulse therapy [ Time Frame: 14 days ]
    need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  125. Use of convalescent plasma [ Time Frame: 14 days ]
    need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

  126. Assisted Mechanical Ventilation (AMV) [ Time Frame: 1 month ]
    need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

  127. Use of neuromuscular blocker [ Time Frame: 14 days ]
    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.

  128. Use of Extracorporeal Circulation (ECMO) [ Time Frame: 1 month ]
    need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.

  129. Renal replacement therapy (dialysis) [ Time Frame: 1 month ]
    need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

  130. Blood products [ Time Frame: 1 month ]
    need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

  131. Other therapeutic modalities [ Time Frame: 1 month ]
    need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.

  132. Amniotic fluid in the last ultrasound examination [ Time Frame: 14 days ]
    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).

  133. Fetal growth restriction [ Time Frame: 14 days ]
    defined by the Delphi procedure 2016⁠. Yes / No categorical and dichotomous variable.

  134. Small fetus for gestational age (SGA) [ Time Frame: 14 days ]
    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.

  135. Presence of fetal morphological changes [ Time Frame: 1 month ]
    presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.

  136. Fetal morphological changes [ Time Frame: 1 month ]
    description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.

  137. Frequency of fetal tachycardia (FFT) [ Time Frame: 1 month ]
    increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.

  138. Doppler velocimetry parameters in the last ultrasound examination [ Time Frame: 1 month ]
    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.

  139. Gestational age of amniocentesis [ Time Frame: 1 month ]
    gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.

  140. Amniocentesis indications [ Time Frame: 1 month ]
    indication for amniocentesis, due to COVID-19 or another cause.

  141. Result of amniocentesis for COVID19 [ Time Frame: 1 month ]
    result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.

  142. Amniocentesis cytokines [ Time Frame: 1 month ]
    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).

  143. Need for hospitalization due to obstetric causes [ Time Frame: 1 month ]
    need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.

  144. Maternal hospital stay [ Time Frame: 1 month ]
    total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.

  145. Obesity [ Time Frame: 1 month ]
    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.

  146. Chronic arterial hypertension (CAH) [ Time Frame: 1 month ]
    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.

  147. Superimposed preeclampsia [ Time Frame: 1 month ]
    defined as CAH associated with signs of severity⁠. Yes / No categorical and dichotomous variable.

  148. Gestational hypertension [ Time Frame: 1 month ]
    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.

  149. Pre-eclampsia [ Time Frame: 1 month ]
    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.

  150. Eclampsia [ Time Frame: 1 month ]
    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.

  151. HELLP syndrome [ Time Frame: 1 month ]
    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.

  152. Clinical diabetes [ Time Frame: 1 month ]
    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.

  153. Gestational diabetes [ Time Frame: 1 month ]
    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.

  154. Premature rupture of membranes [ Time Frame: 1 month ]
    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.

  155. Premature labor [ Time Frame: 1 month ]
    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.

  156. Placenta previa [ Time Frame: 1 month ]
    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.

  157. Abortion [ Time Frame: 1 month ]
    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.

  158. Normally inserted placental abruption [ Time Frame: 1 month ]
    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.

  159. Maternal urinary tract infection [ Time Frame: 1 month ]
    defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.

  160. Maternal heart disease [ Time Frame: 1 month ]
    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.

  161. Bronchial asthma [ Time Frame: 1 month ]
    as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.

  162. Chronic obstructive pulmonary disease (COPD) [ Time Frame: 1 month ]
    as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.

  163. Cerebrovascular disease [ Time Frame: 1 month ]
    as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.

  164. Chronic kidney injury [ Time Frame: 1 month ]
    as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.

  165. Immunosuppression [ Time Frame: 1 month ]
    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.

  166. Maternal pneumonia [ Time Frame: 1 month ]
    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.

  167. Maternal sepsis [ Time Frame: 1 month ]
    life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.

  168. Septic shock [ Time Frame: 1 month ]
    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.

  169. Severe acute respiratory syndrome (SARS) [ Time Frame: 1 month ]
    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.

  170. Postpartum hemorrhage [ Time Frame: 14 days ]
    increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.

  171. Infection of the operative site [ Time Frame: 14 days ]
    exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.

  172. Endometritis [ Time Frame: 14 days ]
    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.

  173. Peritonitis [ Time Frame: 14 days ]
    characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.

  174. Need for postpartum hysterectomy [ Time Frame: 1 month ]
    removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.

  175. Type of delivery [ Time Frame: 1 hour ]
    defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.

  176. Indication of cesarean section [ Time Frame: 1 hour ]
    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.

  177. Gestational age at birth [ Time Frame: 1 hour ]
    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.

  178. Use of labor analgesia [ Time Frame: 4 hours ]
    use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.

  179. Type of anesthesia for cesarean section [ Time Frame: 1 hour ]
    method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.

  180. Antenatal corticosteroid therapy (pulmonary maturity) [ Time Frame: 14 days ]
    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.

  181. Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia) [ Time Frame: 32 weeks ]
    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.

  182. Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis) [ Time Frame: 14 days ]
    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.

  183. Hospital discharge when pregnant [ Time Frame: 1 month ]
    when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.

  184. Hospital discharge when puerperal [ Time Frame: 1 month ]
    when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.

  185. Maternal death when pregnant [ Time Frame: 1 month ]
    when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.

  186. Maternal death when puerperal [ Time Frame: 45 days ]
    when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.

  187. Fetal death [ Time Frame: 10 hours ]
    birth of a fetus without vitality. Yes / No categorical and dichotomous variable.

  188. Perinatal death [ Time Frame: 27 days ]
    fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.

  189. Birth weight [ Time Frame: 1 hour ]
    as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.

  190. Adequacy of birth weight [ Time Frame: 1 hour ]
    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.

  191. Apgar scores in the first minute [ Time Frame: 1 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.

  192. Apgar scores in the fifth minute [ Time Frame: 5 minutes ]
    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.

  193. Neonatal ICU admission [ Time Frame: 1 hour ]
    defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.

  194. Need for neonatal resuscitation [ Time Frame: 27 days ]
    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.

  195. Need for neonatal mechanical ventilation [ Time Frame: 27 days ]
    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.

  196. Neonatal nasal catheter [ Time Frame: 27 days ]
    need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

  197. Neonatal Continuous Positive Airway Pressure (CPAP) mask [ Time Frame: 27 days ]
    need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

  198. Neonatal hypothermia [ Time Frame: 27 days ]
    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.

  199. Neonatal hypoglycemia [ Time Frame: 27 days ]
    defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

  200. Neonatal infection [ Time Frame: 27 days ]
    defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.

  201. Chorioamnionitis [ Time Frame: 27 days ]
    defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

  202. Neonatal respiratory distress modality [ Time Frame: 1 month ]
    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.

  203. Neonatal congenital infection (TORCHS) [ Time Frame: 1 month ]
    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.

  204. Congenital malformation [ Time Frame: 1 month ]
    defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.

  205. Breastfeeding [ Time Frame: 1 month ]
    exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.

  206. Cord ligation [ Time Frame: 10 minutes ]
    can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.

  207. Skin-to-skin contact [ Time Frame: 1 hour ]
    as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.

  208. Breastfeeding in the delivery room [ Time Frame: 1 hour ]
    according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.

  209. Days of life of the newborn's diagnostic suspicion [ Time Frame: 1 month ]
    days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.

  210. Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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.

  211. Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel) [ Time Frame: 6 months, 12 months and 24 months ]
    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.

  212. Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months [ Time Frame: 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.

  213. Neonatal cytokines [ Time Frame: 6 months, 12 months and 24 months ]
    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)

  214. Neonatal IgM COVID-19 [ Time Frame: 5 days ]
    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.

  215. IgA COVID-19 neonatal serial [ Time Frame: 5 days ]
    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.

  216. Serial neonatal IgG COVID-19 [ Time Frame: 14 days ]
    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.

  217. Neonatal reinfection [ Time Frame: 14 days ]
    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.

  218. Hemoglobin from neonatal diagnosis [ Time Frame: 14 days ]
    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.

  219. Diagnostic neonatal bleeding time (BT) [ Time Frame: 1 month ]
    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.

  220. Diagnostic neonatal clotting time (CT) [ Time Frame: 1 month ]
    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.

  221. Urea from neonatal diagnosis [ Time Frame: 1 month ]
    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.

  222. Creatinine from neonatal diagnosis [ Time Frame: 1 month ]
    value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.

  223. Transaminases of the neonatal diagnosis [ Time Frame: 1 month ]
    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.

  224. Blood culture of the neonatal diagnosis [ Time Frame: 1 month ]
    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.

  225. Uroculture of neonatal diagnosis [ Time Frame: 1 month ]
    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.

  226. IgM COVID-19 - worst neonatal result [ Time Frame: 5 days ]
    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.

  227. Neonatal IgG COVID-19 - worst serial result [ Time Frame: 14 days ]
    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.

  228. Cytokines - worst neonatal result [ Time Frame: 14 days ]
    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).

  229. Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19 [ Time Frame: 1 month ]
    day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

  230. Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19 [ Time Frame: 1 month ]
    day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

  231. Bleeding time - worst neonatal result (BT) [ Time Frame: 1 month ]
    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.

  232. Urea - worst neonatal result [ Time Frame: 1 month ]
    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.

  233. Creatinine - worst neonatal result [ Time Frame: 1 month ]
    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.

  234. Transaminases - worst neonatal result [ Time Frame: 1 month ]
    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.

  235. Blood culture - worst neonatal result [ Time Frame: 1 month ]
    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.

  236. Uroculture - worst neonatal result [ Time Frame: 1 month ]
    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.

  237. Gasometry - worst neonatal result [ Time Frame: 1 hour ]
    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.

  238. Result of RT-PCR of the placenta [ Time Frame: 1 month ]
    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.

  239. Placental viral panel [ Time Frame: 1 month ]
    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.

  240. Histopathological of the placenta [ Time Frame: 1 month ]
    result of the histopathological of the placenta, according to the usual technique.

  241. Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge [ Time Frame: 1 month ]
    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.

  242. Viral panel in breast milk [ Time Frame: 1 month ]
    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.

  243. Presence of alteration of the neonatal chest radiography [ Time Frame: 1 day ]
    presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.

  244. Result of neonatal chest radiography [ Time Frame: 1 day ]
    description of any radiological changes, according to a medical report.

  245. Presence of alteration of the neonatal chest tomography [ Time Frame: 1 day ]
    presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.

  246. Result of neonatal chest tomography [ Time Frame: 1 day ]
    description of any alteration of the tomography, according to a medical report.

  247. Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference [ Time Frame: 6, 12 and 24 months ]
    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.

  248. Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight [ Time Frame: 6, 12 and 24 months ]
    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.

  249. Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height [ Time Frame: 6, 12 and 24 months ]
    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.

  250. Development of the newborn up to 6 months [ Time Frame: 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.

  251. Development of the newborn up to 12 months [ Time Frame: 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.

  252. Development of the newborn up to 24 months [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Pregnant and postpartum women admitted with flu syndrome in six reference centers in the Northeast of Brazil.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462367


Contacts
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Contact: LEILA KATZ, MD, PhD 55 81 21224100 ext 4739 katzleila@gmail.com
Contact: MELANIA M AMORIM, MD, PhD 55 81 21224100 ext 4739 profmelania.amorim@gmail.com

Locations
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Brazil
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50.070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
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Principal Investigator: LEILA KATZ, MD, PhD Instituto Materno Infantil Prof. Fernando Figueira
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Responsible Party: Leila Katz, Principal Investigator, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT04462367    
Other Study ID Numbers: NCOVIP
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira:
coronavirus
COVID-19
coronavirus infection
severe acute respiratory syndrome
coronavirus 2
SRAS-CoV-2
pregnancy
maternal mortality
perinatal mortality
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases