Northeast COVID-19 and Pregnancy Study Group — NCOVIP  

COVID19 Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• COVID19
• Pregnancy Disease
• Severe Acute Respiratory Syndrome

• NCT number: NCT04462367
• Study type: Observational
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Status: Active, not recruiting
• Start date: July 1, 2020
• Completion date: December 20, 2024