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COVID-19 and Obstetric Transmission (COVIDOB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418557
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Cuyahoga County Board of Health
The Cleveland Clinic
MetroHealth Medical Center
Case Western Reserve University
Information provided by (Responsible Party):
Rachel Pope, 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 in Cuyahoga County.

Condition or disease Intervention/treatment
COVID Pregnancy Complications 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. The aim will be to evaluate maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular response.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: COVID-19 and Obstetric Transmission
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

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.




Primary Outcome Measures :
  1. Presence of COVID-19 virus [ Time Frame: At time of delivery ]
    Viral presence in any of the collected specimens


Secondary Outcome Measures :
  1. Presence of antibodies to COVID-19 virus [ Time Frame: At time of delivery and 24 hours of life of the newborn ]
    Antibodies detected in any of the collected specimens


Other Outcome Measures:
  1. 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 [ Time Frame: At time of delivery and 24 hours of life of the newborn ]
    Innate/Adaptive cell function and immune response


Biospecimen Retention:   Samples With DNA
Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal secretion, cord blood, newborn throat swab, breastmilk


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   must be pregnant
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418557


Contacts
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Contact: Rachel Pope, MD, MPH 4129792939 rachel.pope@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Rachel Pope, MD, MPH         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Cuyahoga County Board of Health
The Cleveland Clinic
MetroHealth Medical Center
Case Western Reserve University
Publications of Results:
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Responsible Party: Rachel Pope, Assistant Professor, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT04418557    
Other Study ID Numbers: 20200479
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Antibodies
Immunologic Factors
Physiological Effects of Drugs