COVID-19 and Obstetric Transmission (COVIDOB)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; COVID
• Intervention / Treatment: Diagnostic test: RT-PCR and antibody testing

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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women without COVID-19 Infection; 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; Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.
Pregnant women with a history of COVID-19 infection; 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; Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.
Pregnant women vaccinated for COVID-19; Women who are vaccinated against COVID-19 at any point during their pregnancy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: The Cleveland Clinic; Case Western Reserve University; MetroHealth Medical Center; Cuyahoga County Board of Health

Publications and helpful links

General Publications

• 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.
• 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 medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2020
• Primary Completion (ACTUAL): July 15, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (ACTUAL): June 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 20200479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No