COVID-19 and Obstetric Transmission

Completed

• Conditions: COVID; Pregnancy Complications
• Interventions: Diagnostic Test: RT-PCR and antibody testing

• Registration Number: NCT04418557
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2020-04-28
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

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Exclusion Criteria

• COVID-19 infection before or after pregnancy
• Person under investigation, but not a presumed or known positive case

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women without COVID-19 Infection	RT-PCR and antibody testing	Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative
Pregnant women with a history of COVID-19 infection	RT-PCR and antibody testing	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

Primary Outcome Measures

Name	Time	Method
Presence of COVID-19 virus	At time of delivery	Viral presence in any of the collected specimens

Secondary Outcome Measures

Name	Time	Method
Presence of antibodies to COVID-19 virus	At time of delivery and 24 hours of life of the newborn	Antibodies detected in any of the collected specimens

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States