COVID-19 and Obstetric Transmission
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Presence of COVID-19 virus
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Rachel Pope
Assistant Professor
University Hospitals Cleveland Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Presence of COVID-19 virus
Time Frame: At time of delivery
Viral presence in any of the collected specimens
Secondary Outcomes
- Presence of antibodies to COVID-19 virus(At time of delivery and 24 hours of life of the newborn)