COVIDCOVIDOBNCT04418557
COVID-19 and Obstetric Transmission
An observational study of COVID and Pregnancy Complications, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID, Pregnancy Complications
- What is being tested?
- RT-PCR and antibody testing
- Type of treatment
- Vaccines
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 15 Jul 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.
Who may be able to join
- 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
Who cannot join
- COVID-19 infection before or after pregnancy
- Person under investigation, but not a presumed or known positive case
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- COVID, Pregnancy Complications
- Being tested
- RT-PCR and antibody testing
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of COVID-19 virus
Viral presence in any of the collected specimens
Measured: At time of delivery
Secondary outcomes (1)
Presence of antibodies to COVID-19 virus
Antibodies detected in any of the collected specimens
Measured: At time of delivery and 24 hours of life of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start28 Apr 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cuyahoga County Board of Health, The Cleveland Clinic, MetroHealth Medical Center, Case Western Reserve University
- Responsible party
- Principal investigator, Rachel Pope, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418557
- Sponsor's protocol ID
- 20200479
- Acronym
- COVIDOB
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32215581Chen 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.
PubMed 32151335
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Obstetric Transmission
- ClinicalTrials.gov ID
- NCT04418557
- Acronym / sponsor ID
- COVIDOB / 20200479
- Conditions
- COVID, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Cuyahoga County Board of Health, The Cleveland Clinic, MetroHealth Medical Center, Case Western Reserve University
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women without COVID-19 Infection | – | Diagnostic Test: RT-PCR and antibody testingWomen who are tested for COVID-19 at the time of admission for labor and delivery and test negative |
| Pregnant women with a history of COVID-19 infection | – | Diagnostic Test: RT-PCR and antibody testingWomen 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 |
| Pregnant women vaccinated for COVID-19 | – | –Women who are vaccinated against COVID-19 at any point during their pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- COVID-19 infection before or after pregnancy
- Person under investigation, but not a presumed or known positive case
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCR and antibody testingTesting of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk. | Diagnostic test | Pregnant women with a history of COVID-19 infection, Pregnant women without COVID-19 Infection |
Primary outcome
Presence of COVID-19 virus
Time frame: At time of delivery
Viral presence in any of the collected specimens
1 secondary outcome
Presence of antibodies to COVID-19 virus
Time frame: At time of delivery and 24 hours of life of the newborn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Results publication: PubMed 32215581Dong 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.
- Results publication: PubMed 32151335Chen 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.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Pregnancy Complications, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of COVID-19 virus (time frame: At time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418557, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.