COVID, Pregnancy Complications
Conditions
Brief summary
The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies exposed to a COVID-19 vaccine in Cuyahoga County.
Detailed description
A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR; 10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19 positive were surveilled for vertical transmission and overall obstetric and early neonatal outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at the time of delivery, and breastmilk samples were collected after lactation commenced. There was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom have tested positively for COVID-19 after delivery from an infected mother. Most recently, antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery to a known positive mother. Therefore, vertical transmission has not been completely ruled out. Additionally, infection at varying times of pregnancy has not been well delineated or correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need to continue surveying and documenting clinical findings in obstetric COVID-19 cases. This study will follow pregnant women who are diagnosed during any point of their pregnancy with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular response.
Interventions
DIAGNOSTIC_TESTRT-PCR and antibody testing
Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.
Sponsors
Cuyahoga County Board of Health
The Cleveland Clinic
MetroHealth Medical Center
Case Western Reserve University
University Hospitals Cleveland Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* COVID-19 infection at any time of the pregnancy, or presumed case by symptoms and direct contact with a positive case * Pregnancy documented by ultrasound
Exclusion criteria
* COVID-19 infection before or after pregnancy * Person under investigation, but not a presumed or known positive case
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of COVID-19 virus | At time of delivery | Viral presence in any of the collected specimens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of antibodies to COVID-19 virus | At time of delivery and 24 hours of life of the newborn | Antibodies detected in any of the collected specimens |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus | At time of delivery and 24 hours of life of the newborn | Innate/Adaptive cell function and immune response |
Countries
United States
Outcome results
None listed