COVID-19 and Obstetric Transmission

Study Overview
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Brief Summary
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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
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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.

Official Title
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COVID-19 and Obstetric Transmission

Conditions
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COVID, Pregnancy Complications

Intervention / Treatment
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* Diagnostic Test: RT-PCR and antibody testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women without COVID-19 Infection<br>Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative | Diagnostic Test: RT-PCR and antibody testing<br>* Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.<br>|
| Pregnant women with a history of COVID-19 infection<br>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 | Diagnostic Test: RT-PCR and antibody testing<br>* Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.<br>|
| Pregnant women vaccinated for COVID-19<br>Women who are vaccinated against COVID-19 at any point during their pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of COVID-19 virus | Viral presence in any of the collected specimens | At time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of antibodies to COVID-19 virus | Antibodies detected in any of the collected specimens | At time of delivery and 24 hours of life of the newborn |