COVID-19 and Obstetric Transmission (COVIDOB)

University Hospitals (UH)

Status: Completed

Conditions: Pregnancy Complications; COVID

Treatments: Diagnostic Test: RT-PCR and antibody testing

Study type: Observational

Funder types: Other

Identifiers

NCT04418557

20200479

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

64 participants in 3 patient groups

Pregnant women without COVID-19 Infection

Description:

Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative

Treatment:

Diagnostic Test: RT-PCR and antibody testing

Pregnant women with a history of COVID-19 infection

Description:

Women who are tested for COVID-19 at any point during their pregnancy, including at the time of admission for labor and delivery, and test positive

Treatment:

Diagnostic Test: RT-PCR and antibody testing

Pregnant women vaccinated for COVID-19

Description:

Women who are vaccinated against COVID-19 at any point during their pregnancy