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Published on: July 21, 2016
Gestation and COVID-19: clinical and microbiological observational study (Gesta-COVID19)
Anna Suy1, Itziar Garcia-Ruiz2, Melchor Carbonell1
1Department of Obstetrics, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Insights
This study investigates Coronavirus Disease 2019 (COVID-19) effects on pregnancy. Researchers will analyze maternal and fetal outcomes, and SARS-CoV-2 behavior in pregnant women and newborns.
Area of Science:
- Obstetrics and Gynecology
- Infectious Diseases
- Virology
Background:
- Coronavirus Disease 2019 (COVID-19) is a global pandemic with unclear effects on pregnancy.
- Conflicting evidence exists regarding SARS-CoV-2 impact on maternal and fetal health.
- SARS-CoV-2 has been detected in various pregnancy-related biological samples.
Purpose of the Study:
- To investigate the effects of COVID-19 on pregnancy outcomes.
- To understand how pregnancy status influences the evolution of SARS-CoV-2 disease.
- To assess the risk of vertical transmission and viral behavior in biological fluids.
Main Methods:
- A descriptive, multicenter, longitudinal, observational study across eight Spanish tertiary care hospitals.
- Inclusion of pregnant women with positive SARS-CoV-2 tests and their newborns.
- Collection and analysis of various biological samples (placenta, amniotic fluid, breastmilk, etc.) for viral detection and transmission studies.
- Follow-up of neonates for up to 6 months to determine neonatal transmission rates.
Main Results:
- The study aims to collect data from 150 pregnant women and their infants.
- Analysis will focus on maternal and fetal effects, viral presence in biological samples, and vertical transmission.
- Longitudinal follow-up will provide insights into neonatal outcomes and transmission rates.
Conclusions:
- Limited information exists on COVID-19's effects during pregnancy and postpartum.
- This study will provide comprehensive data on SARS-CoV-2 behavior in a Spanish pregnant population.
- Findings will elucidate the impact of COVID-19 on pregnancy and neonates.
Background:
The Coronavirus Disease 2019 (COVID-19) is a novel disease which has been having a worldwide affect since December 2019. Evidence regarding the effects of SARS-CoV-2 during pregnancy is conflicting. The presence of SARS-CoV-2 has been demonstrated in biological samples during pregnancy (placenta, umbilical cord or amniotic fluid); however, maternal and fetal effects of the virus are not well known.
Methods:
Descriptive, multicentre, longitudinal, observational study in eight tertiary care hospitals throughout Spain, that are referral centres for pregnant women with COVID-19. All pregnant women with positive SARS-CoV-2 real-time reverse transcriptase polymerase chain reaction during their pregnancy or 14 days preconception and newborns born to mothers infected with SARS-CoV-2 will be included. They will continue to be followed up until 4 weeks after delivery. The aim of the study is to investigate both the effect of COVID-19 on the pregnancy, and the effect of the pregnancy status with the evolution of the SARS-CoV-2 disease. Other samples (faeces, urine, serum, amniotic fluid, cord and peripheral blood, placenta and breastmilk) will be collected in order to analyse whether or not there is a risk of vertical transmission and to describe the behaviour of the virus in other fluids. Neonates will be followed until 6 months after delivery to establish the rate of neonatal transmission. We aim to include 150 pregnant women and their babies. Ethics approval will be obtained from all the participating centres.
Discussion:
There is little information known about COVID-19 and its unknown effects on pregnancy. This study will collect a large number of samples in pregnant women which will allow us to demonstrate the behaviour of the virus in pregnancy and postpartum in a representative cohort of the Spanish population.
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