Clinical trial NCT04462367: Northeast COVID-19 and Pregnancy Study Group
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID19
Coronavirus Infection
Pregnancy Disease
Severe Acute Respiratory Syndrome
Keywords: coronavirus
COVID-19
coronavirus infection
severe acute respiratory syndrome
coronavirus 2
SRAS-CoV-2
pregnancy
maternal mortality
perinatal mortality
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant and postpartum women admitted with flu syndrome in six reference centers in the Northeast of Brazil.

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.

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.

Eligibility 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).

Primary outcomes:
measure: Near miss maternal:
timeFrame: 42 days
measure: Maternal death
timeFrame: 42 days
measure: Near miss neonate
timeFrame: 7 days
measure: Neonatal death
timeFrame: 27 days
measure: Early neonatal death
timeFrame: 7 days
measure: Fetal death
timeFrame: 1 hour
measure: Perinatal death
timeFrame: 7 days
Secondary outcomes:
measure: Maternal age
timeFrame: 1 hour
measure: Maternal pre-pregnancy weight
timeFrame: 1 hour
measure: Maternal height
timeFrame: 1 hour
measure: Pre-gestational nutritional classification
timeFrame: 1 hour
measure: Pre-gestational body mass index (BMI)
timeFrame: 1 hour
measure: Maternal color
timeFrame: 1 hour
measure: Number of people living in the household
timeFrame: 1 hour
measure: Family income per capita
timeFrame: 1 hour
measure: Maternal education
timeFrame: 1 hour
measure: Maternal occupation
timeFrame: 1 hour
measure: Maternal occupation with financial income
timeFrame: 1 hour
measure: Maternal marital status
timeFrame: 1 hour
measure: Maternal origin
timeFrame: 1 hour
measure: Maternal religion
timeFrame: 1 hour
measure: Maternal smoking
timeFrame: 1 hour
measure: Maternal alcoholism
timeFrame: 1 hour
measure: Maternal use of illicit drugs
timeFrame: 1 hour
measure: Number of pregnancies
timeFrame: 1 hour
measure: Parity
timeFrame: 1 hour
measure: Number of previous cesarean sections
timeFrame: 1 hour
measure: Number of previous vaginal births
timeFrame: 1 hour
measure: Number of previous abortions
timeFrame: 1 hour
measure: Number of children alive
timeFrame: 1 hour
measure: Number of prenatal consultations
timeFrame: 1 hour
measure: Gestational age of the onset of flu-like signs and symptoms
timeFrame: 1 hour
measure: Number of puerperium days of onset of flu-like signs and symptoms
timeFrame: 14 days
measure: Duration of maternal symptoms
timeFrame: 1 hour
measure: Social isolation during the signs and symptoms of flu-like syndrome
timeFrame: 14 days
measure: Social distance before the signs and symptoms of flu-like syndrome
timeFrame: 1 hour
measure: Quarantine
timeFrame: 14 days
measure: Need for hospitalization due to flu-like syndrome and/or complications
timeFrame: 1 hour
measure: Day of hospitalization due to flu syndrome and/or complications
timeFrame: 1 hour
measure: Length of hospital stay due to flu-like syndrome and/or complications
timeFrame: 14 days
measure: Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months
timeFrame: 24 months
measure: Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months
timeFrame: 24 months
measure: Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel)
timeFrame: 10 days
measure: Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months
timeFrame: 24 months
measure: Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months
timeFrame: 24 months
measure: Serial maternal IgM COVID-19
timeFrame: 6 months, 12 months and 24 months
measure: Serial maternal IgA COVID-19
timeFrame: 6 months, 12 months and 24 months
measure: Serial maternal IgG COVID-19
timeFrame: 6 months, 12 months and 24 months
measure: Serial maternal serology day
timeFrame: 6 months, 12 months and 24 months
measure: Maternal reinfection
timeFrame: 14 days
measure: Cytokines in maternal diagnosis
timeFrame: 14 days
measure: Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Day of the first blood count from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Hemoglobin of maternal diagnosis
timeFrame: 14 days
measure: Leukocytes from maternal diagnosis
timeFrame: 14 days
measure: Deviation to the left of the maternal diagnosis
timeFrame: 14 days
measure: Platelets of maternal diagnosis
timeFrame: 14 days
measure: Typical lymphocytes of maternal diagnosis
timeFrame: 14 days
measure: Atypical lymphocytes of maternal diagnosis
timeFrame: 14 days
measure: Day of the first coagulogram from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Maternal diagnosis bleeding time (TB)
timeFrame: 14 days
measure: Maternal diagnosis clotting time (CT)
timeFrame: 14 days
measure: Maternal prothrombin time of diagnosis (TD)
timeFrame: 14 days
measure: Maternal active partial thromboplastin time of diagnosis (APTT)
timeFrame: 14 days
measure: International normalized ratio (INR)
timeFrame: 14 days
measure: Day of the first urea from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Urea from maternal diagnosis
timeFrame: 14 days
measure: Day of the first creatinine from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Creatinine of maternal diagnosis
timeFrame: 14 days
measure: Transaminases in maternal diagnosis
timeFrame: 14 days
measure: Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19:
timeFrame: 14 days
measure: VSH of maternal diagnosis
timeFrame: 14 days
measure: Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: CRP of maternal diagnosis
timeFrame: 14 days
measure: Day of the first D-dimer from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: D-dimer of maternal diagnosis
timeFrame: 14 days
measure: Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: DHL of maternal diagnosis
timeFrame: 14 days
measure: Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Alkaline phosphatase in maternal diagnosis
timeFrame: 14 days
measure: Day of the first troponin from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Troponin in maternal diagnosis
timeFrame: 14 days
measure: Day of the first ferritin from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Ferritin in maternal diagnosis
timeFrame: 14 days
measure: Bilirubins in maternal diagnosis
timeFrame: 14 days
measure: Day of the first blood culture from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Blood culture of maternal diagnosis
timeFrame: 14 days
measure: Blood culture microorganism in maternal diagnosis
timeFrame: 14 days
measure: Day of the first uroculture from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Uroculture of maternal diagnosis
timeFrame: 14 days
measure: Uroculture microorganism in maternal diagnosis
timeFrame: 14 days
measure: IgM COVID-19 worst maternal result
timeFrame: 5 days
measure: IgA COVID-19 worst maternal result
timeFrame: 5 days
measure: Maternal IgG COVID-19 - worst serial result
timeFrame: 14 days
measure: Cytokines worst maternal outcome
timeFrame: 14 days
measure: Day of the worst urea result from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Urea worst maternal result
timeFrame: 14 days
measure: Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: Creatinine worst maternal result
timeFrame: 14 days
measure: Transaminases worst maternal outcome
timeFrame: 14 days
measure: Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: VSH worst maternal result
timeFrame: 14 days
measure: Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19
timeFrame: 14 days
measure: CRP worst maternal result
timeFrame: 14 days
measure: Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19
timeFrame: 14 days
measure: D-dimer worst maternal result
timeFrame: 14 days
measure: Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19
timeFrame: 14 days
measure: DHL worst maternal result
timeFrame: 14 days
measure: Alkaline phosphatase worst maternal result
timeFrame: 14 days
measure: Troponin worst maternal result
timeFrame: 14 days
measure: Ferritin worst maternal result
timeFrame: 14 days
measure: Bilirubins worst maternal result
timeFrame: 14 days
measure: Blood culture worst maternal result
timeFrame: 14 days
measure: Blood culture microorganism worst maternal result
timeFrame: 14 days
measure: Uroculture worse maternal result
timeFrame: 14 days
measure: Uroculture microorganism worst maternal result
timeFrame: 14 days
measure: Presence of changes in maternal chest radiography
timeFrame: 14 days
measure: Result of maternal chest radiography
timeFrame: 14 days
measure: Presence of changes in the mother's chest tomography
timeFrame: 14 days
measure: Day of normalization of the alteration of the tomography of the maternal chest
timeFrame: 14 days
measure: Result of maternal chest tomography
timeFrame: 14 days
measure: Use of maternal nasal catheter
timeFrame: 1 month
measure: Use of maternal Venturi Mask
timeFrame: 1 month
measure: Prone maternal position on spontaneous ventilation
timeFrame: 1 month
measure: Use of therapeutic antibiotics
timeFrame: 14 days
measure: Use of azithromycin
timeFrame: 14 days
measure: Use of maternal hydroxychloroquine/chloroquine
timeFrame: 14 days
measure: Use of antiparasitic drugs
timeFrame: 14 days
measure: Use of anticoagulant
timeFrame: 14 days
measure: Use of antiretroviral
timeFrame: 14 days
measure: Use of pulse therapy
timeFrame: 14 days
measure: Use of convalescent plasma
timeFrame: 14 days
measure: Assisted Mechanical Ventilation (AMV)
timeFrame: 1 month
measure: Use of neuromuscular blocker
timeFrame: 14 days
measure: Use of Extracorporeal Circulation (ECMO)
timeFrame: 1 month
measure: Renal replacement therapy (dialysis)
timeFrame: 1 month
measure: Blood products
timeFrame: 1 month
measure: Other therapeutic modalities
timeFrame: 1 month
measure: Amniotic fluid in the last ultrasound examination
timeFrame: 14 days
measure: Fetal growth restriction
timeFrame: 14 days
measure: Small fetus for gestational age (SGA)
timeFrame: 14 days
measure: Presence of fetal morphological changes
timeFrame: 1 month
measure: Fetal morphological changes
timeFrame: 1 month
measure: Frequency of fetal tachycardia (FFT)
timeFrame: 1 month
measure: Doppler velocimetry parameters in the last ultrasound examination
timeFrame: 1 month
measure: Gestational age of amniocentesis
timeFrame: 1 month
measure: Amniocentesis indications
timeFrame: 1 month
measure: Result of amniocentesis for COVID19
timeFrame: 1 month
measure: Amniocentesis cytokines
timeFrame: 1 month
measure: Need for hospitalization due to obstetric causes
timeFrame: 1 month
measure: Maternal hospital stay
timeFrame: 1 month
measure: Obesity
timeFrame: 1 month
measure: Chronic arterial hypertension (CAH)
timeFrame: 1 month
measure: Superimposed preeclampsia
timeFrame: 1 month
measure: Gestational hypertension
timeFrame: 1 month
measure: Pre-eclampsia
timeFrame: 1 month
measure: Eclampsia
timeFrame: 1 month
measure: HELLP syndrome
timeFrame: 1 month
measure: Clinical diabetes
timeFrame: 1 month
measure: Gestational diabetes
timeFrame: 1 month
measure: Premature rupture of membranes
timeFrame: 1 month
measure: Premature labor
timeFrame: 1 month
measure: Placenta previa
timeFrame: 1 month
measure: Abortion
timeFrame: 1 month
measure: Normally inserted placental abruption
timeFrame: 1 month
measure: Maternal urinary tract infection
timeFrame: 1 month
measure: Maternal heart disease
timeFrame: 1 month
measure: Bronchial asthma
timeFrame: 1 month
measure: Chronic obstructive pulmonary disease (COPD)
timeFrame: 1 month
measure: Cerebrovascular disease
timeFrame: 1 month
measure: Chronic kidney injury
timeFrame: 1 month
measure: Immunosuppression
timeFrame: 1 month
measure: Maternal pneumonia
timeFrame: 1 month
measure: Maternal sepsis
timeFrame: 1 month
measure: Septic shock
timeFrame: 1 month
measure: Severe acute respiratory syndrome (SARS)
timeFrame: 1 month
measure: Postpartum hemorrhage
timeFrame: 14 days
measure: Infection of the operative site
timeFrame: 14 days
measure: Endometritis
timeFrame: 14 days
measure: Peritonitis
timeFrame: 14 days
measure: Need for postpartum hysterectomy
timeFrame: 1 month
measure: Type of delivery
timeFrame: 1 hour
measure: Indication of cesarean section
timeFrame: 1 hour
measure: Gestational age at birth
timeFrame: 1 hour
measure: Use of labor analgesia
timeFrame: 4 hours
measure: Type of anesthesia for cesarean section
timeFrame: 1 hour
measure: Antenatal corticosteroid therapy (pulmonary maturity)
timeFrame: 14 days
measure: Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia)
timeFrame: 32 weeks
measure: Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis)
timeFrame: 14 days
measure: Hospital discharge when pregnant
timeFrame: 1 month
measure: Hospital discharge when puerperal
timeFrame: 1 month
measure: Maternal death when pregnant
timeFrame: 1 month
measure: Maternal death when puerperal
timeFrame: 45 days
measure: Fetal death
timeFrame: 10 hours
measure: Perinatal death
timeFrame: 27 days
measure: Birth weight
timeFrame: 1 hour
measure: Adequacy of birth weight
timeFrame: 1 hour
measure: Apgar scores in the first minute
timeFrame: 1 minute
measure: Apgar scores in the fifth minute
timeFrame: 5 minutes
measure: Neonatal ICU admission
timeFrame: 1 hour
measure: Need for neonatal resuscitation
timeFrame: 27 days
measure: Need for neonatal mechanical ventilation
timeFrame: 27 days
measure: Neonatal nasal catheter
timeFrame: 27 days
measure: Neonatal Continuous Positive Airway Pressure (CPAP) mask
timeFrame: 27 days
measure: Neonatal hypothermia
timeFrame: 27 days
measure: Neonatal hypoglycemia
timeFrame: 27 days
measure: Neonatal infection
timeFrame: 27 days
measure: Chorioamnionitis
timeFrame: 27 days
measure: Neonatal respiratory distress modality
timeFrame: 1 month
measure: Neonatal congenital infection (TORCHS)
timeFrame: 1 month
measure: Congenital malformation
timeFrame: 1 month
measure: Breastfeeding
timeFrame: 1 month
measure: Cord ligation
timeFrame: 10 minutes
measure: Skin-to-skin contact
timeFrame: 1 hour
measure: Breastfeeding in the delivery room
timeFrame: 1 hour
measure: Days of life of the newborn's diagnostic suspicion
timeFrame: 1 month
measure: Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months
timeFrame: 6 months, 12 months and 24 months
measure: Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel)
timeFrame: 6 months, 12 months and 24 months
measure: Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months
timeFrame: 6 months, 12 months and 24 months
measure: Neonatal cytokines
timeFrame: 6 months, 12 months and 24 months
measure: Neonatal IgM COVID-19
timeFrame: 5 days
measure: IgA COVID-19 neonatal serial
timeFrame: 5 days
measure: Serial neonatal IgG COVID-19
timeFrame: 14 days
measure: Neonatal reinfection
timeFrame: 14 days
measure: Hemoglobin from neonatal diagnosis
timeFrame: 14 days
measure: Diagnostic neonatal bleeding time (BT)
timeFrame: 1 month
measure: Diagnostic neonatal clotting time (CT)
timeFrame: 1 month
measure: Urea from neonatal diagnosis
timeFrame: 1 month
measure: Creatinine from neonatal diagnosis
timeFrame: 1 month
measure: Transaminases of the neonatal diagnosis
timeFrame: 1 month
measure: Blood culture of the neonatal diagnosis
timeFrame: 1 month
measure: Uroculture of neonatal diagnosis
timeFrame: 1 month
measure: IgM COVID-19 - worst neonatal result
timeFrame: 5 days
measure: Neonatal IgG COVID-19 - worst serial result
timeFrame: 14 days
measure: Cytokines - worst neonatal result
timeFrame: 14 days
measure: Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19
timeFrame: 1 month
measure: Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19
timeFrame: 1 month
measure: Bleeding time - worst neonatal result (BT)
timeFrame: 1 month
measure: Urea - worst neonatal result
timeFrame: 1 month
measure: Creatinine - worst neonatal result
timeFrame: 1 month
measure: Transaminases - worst neonatal result
timeFrame: 1 month
measure: Blood culture - worst neonatal result
timeFrame: 1 month
measure: Uroculture - worst neonatal result
timeFrame: 1 month
measure: Gasometry - worst neonatal result
timeFrame: 1 hour
measure: Result of RT-PCR of the placenta
timeFrame: 1 month
measure: Placental viral panel
timeFrame: 1 month
measure: Histopathological of the placenta
timeFrame: 1 month
measure: Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge
timeFrame: 1 month
measure: Viral panel in breast milk
timeFrame: 1 month
measure: Presence of alteration of the neonatal chest radiography
timeFrame: 1 day
measure: Result of neonatal chest radiography
timeFrame: 1 day
measure: Presence of alteration of the neonatal chest tomography
timeFrame: 1 day
measure: Result of neonatal chest tomography
timeFrame: 1 day
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference
timeFrame: 6, 12 and 24 months
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight
timeFrame: 6, 12 and 24 months
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height
timeFrame: 6, 12 and 24 months
measure: Development of the newborn up to 6 months
timeFrame: 6 months
measure: Development of the newborn up to 12 months
timeFrame: 12 months
measure: Development of the newborn up to 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto Materno Infantil Prof. Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
name: LEILA KATZ, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: