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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418557
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : July 22, 2022
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

Tracking Information
First Submitted Date June 3, 2020
First Posted Date June 5, 2020
Last Update Posted Date July 22, 2022
Actual Study Start Date April 28, 2020
Actual Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2020)
Presence of COVID-19 virus [ Time Frame: At time of delivery ]
Viral presence in any of the collected specimens
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2020)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title COVID-19 and Obstetric Transmission
Official Title COVID-19 and Obstetric Transmission
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal secretion, cord blood, newborn throat swab, breastmilk
Sampling Method Non-Probability Sample
Study Population Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.
Condition
  • 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.
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: RT-PCR and antibody testing
  • 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
    Intervention: Diagnostic Test: RT-PCR and antibody testing
  • Pregnant women vaccinated for COVID-19
    Women who are vaccinated against COVID-19 at any point during their pregnancy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2022)
64
Original Estimated Enrollment
 (submitted: June 3, 2020)
200
Actual Study Completion Date July 15, 2021
Actual Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: must be pregnant
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04418557
Other Study ID Numbers 20200479
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Rachel Pope, University Hospitals Cleveland Medical Center
Original Responsible Party Same as current
Current Study Sponsor University Hospitals Cleveland Medical Center
Original Study Sponsor Same as current
Collaborators
  • Cuyahoga County Board of Health
  • The Cleveland Clinic
  • MetroHealth Medical Center
  • Case Western Reserve University
Investigators Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date July 2022