---
title: Northeast COVID-19 and Pregnancy Study Group
nct_id: NCT04462367
overall_status: UNKNOWN
sponsor: Instituto Materno Infantil Prof. Fernando Figueira
study_type: OBSERVATIONAL
primary_condition: COVID19
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04462367.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04462367"
ct_last_update_post_date: 2024-03-06
last_seen_at: "2026-05-12T07:18:31.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04462367](https://clinicaltrials.gov/study/NCT04462367)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 180
- **Lead Sponsor:** Instituto Materno Infantil Prof. Fernando Figueira
- **Conditions:** COVID19, Coronavirus Infection, Pregnancy Disease, Severe Acute Respiratory Syndrome
- **Start Date:** 2020-07-01
- **Completion Date:** 2024-12-20
- **CT.gov Last Update:** 2024-03-06

## 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

- **Sex:** FEMALE

```
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

- **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.
- **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.
- **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.
- **Neonatal death** _(time frame: 27 days)_ — Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.
- **Early neonatal death** _(time frame: 7 days)_ — Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable
- **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.
- **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 Outcomes

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

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.instituto materno infantil prof. fernando figueira|recife|pernambuco|brazil` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT04462367.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04462367*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*