Northeast COVID-19 and Pregnancy Study Group

NCT04462367 | Active Not Recruiting

• 1 other identifier: NCOVIP
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• Near miss maternal:

  Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.

  42 days

• Maternal death

  It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.

  42 days

• Near miss neonate

  It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar \<7 in the 5th minute, birth weight \<1,750 grams or gestational age \<33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.

  7 days

• Neonatal death

  Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.

  27 days

• Early neonatal death

  Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable

  7 days

• Fetal death

  Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.

  1 hour

• Perinatal death

  Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.

  7 days

Secondary Outcomes (252)

• Maternal age

  1 hour

• Maternal pre-pregnancy weight

  1 hour

• Maternal height

  1 hour

• Pre-gestational nutritional classification

  1 hour

• Pre-gestational body mass index (BMI)

  1 hour

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, 50.070-550, Brazil

Location

Related Publications (1)

• Cunha CMP, Amorim MMR, Guendler JA, Souza ASR, Katz L. Clinical and epidemiological profile of pregnant and postpartum women affected by COVID-19 who required respiratory support. Rev Bras Ginecol Obstet. 2025 Apr 30;47:e-rbgo14. doi: 10.61622/rbgo/2025rbgo14. eCollection 2025.

  PMID: 40406476 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Maternal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• LEILA KATZ, MD, PhD

  Instituto Materno Infantil Prof. Fernando Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 8, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 20, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

BR (1)