Table 1 Definition of primary and secondary outcomes
From: Gestation and COVID-19: clinical and microbiological observational study (Gesta-COVID19)
Primary outcome | |
Preeclampsia, preterm delivery, need of hospitalization, ICU admittance | Frequency of each complication / total number of pregnant women |
Secondary outcomes | |
Description of COVID-19 maternal symptoms | Frequency of each symptom / Total number of pregnant women |
Maternal mortality | Number of maternal deaths due to COVID-19 or any other complication during the pregnancy / Total number of pregnant women |
Rate of fetal morbidity and mortality | Number of miscarriage, stillbirth, fetal malformation, intrauterine growth restriction / Total number of foetuses |
Description of behaviour of the virus in biological fluids (urine, faeces, blood cord, placenta and breastmilk) | Number of positive tests / Number of tests performed (per each fluid or tissue) |
Neonatal infection at 24, 48 h and 7 days | Number of newborns with positive RT-PCR in pharyngeal aspirate at 24, 48 h and at 7 days / Total number of newborns |
Neonatal mortality | Number of neonatal deaths within the first 7 (early) and 28 days of life / Total number of foetuses/newborns |
Neonatal morbidity (pneumonia, NICU admission, sepsis,…) | Number of each complication / Total number of neonates |