NCT04418557

COVID-19 and Obstetric Transmission

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID
• Pregnancy Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2020-06-05
• Last updated: 2022-07-22

Locations

1 site across 1 country: United States