Official Title
COVID-19 and Obstetric Transmission
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.

Completed
COVID
Pregnancy Complications

Diagnostic Test: RT-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.

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

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
United States
Locations

University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center
NCT Number
MeSH Terms
Pregnancy Complications
Antibodies