COVID-19 and Obstetric Transmission

COVID Clinical Trial

— COVIDOB  

Official title:

COVID-19 and Obstetric Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418557
• Other study ID #: 20200479
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Case Western Reserve University, Cuyahoga County Board of Health, MetroHealth Medical Center, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medi — View Citation

Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus	Innate/Adaptive cell function and immune response	At time of delivery and 24 hours of life of the newborn
Primary	Presence of COVID-19 virus	Viral presence in any of the collected specimens	At time of delivery
Secondary	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