Clinical trial NCT04418557: COVID-19 and Obstetric Transmission
Official title: COVID-19 and Obstetric Transmission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Pregnancy Complications
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Cuyahoga County Board of Health
name: The Cleveland Clinic
name: MetroHealth Medical Center
name: Case Western Reserve University
First posted: 2020-06-05
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.

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.

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

Primary outcomes:
measure: Presence of COVID-19 virus
timeFrame: At time of delivery
Secondary outcomes:
measure: Presence of antibodies to COVID-19 virus
timeFrame: At time of delivery and 24 hours of life of the newborn
Other outcomes:
measure: 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
timeFrame: At time of delivery and 24 hours of life of the newborn
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.