NCT04418557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

June 3, 2020

Last Update Submit

July 20, 2022

Conditions

COVIDPregnancy Complications

Outcome Measures

Primary Outcomes (1)

  • Presence of COVID-19 virus

    Viral presence in any of the collected specimens

    At time of delivery

Secondary Outcomes (1)

  • Presence of antibodies to COVID-19 virus

    At time of delivery and 24 hours of life of the newborn

Other Outcomes (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

    At time of delivery and 24 hours of life of the newborn

Study Arms (3)

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

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

Pregnant women vaccinated for COVID-19

Women who are vaccinated against COVID-19 at any point during their pregnancy

Interventions

RT-PCR and antibody testingDIAGNOSTIC_TEST

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 infectionPregnant women without COVID-19 Infection

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmust be pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

  • 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.

    PMID: 32215581RESULT

  • 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.

    PMID: 32151335RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal secretion, cord blood, newborn throat swab, breastmilk

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Antibody Formation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Immunity, ActiveAdaptive ImmunityImmunityImmune System Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

April 28, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)