Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-04-17 @ 2:22 AM
Study NCT ID:
NCT04418557
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2020-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 and Obstetric Transmission
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
COVID-19 and Obstetric Transmission
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDOB
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: