Characteristics of COVID-19 Infection Among PREGnant Women

NCT04398264 | Completed

• 1 other identifier: U20-05-4055
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.

Conditions

Corona Virus Infection; Pregnancy Related

Keywords

COVID-19; SARS-Cov2; 2019-nCoV; Vertical transmission; Asymptomatic positive; Pandemics; Universal screening; Obstetric; Viral infection

Outcome Measures

Primary Outcomes (1)

• Asymptomatic COVID-19 positive pregnant women

  Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission

  Through completion of the study, an average of 1 year

Secondary Outcomes (4)

• Asymptomatic Hispanic COVID-19 positive pregnant women

  Through completion of the study, an average of 1 year

• Follow up of asymptomatic COVID-19 positive pregnant women

  Through completion of the study, an average of 1 year

• COVID-19 positive newborns

  Through completion of the study, an average of 1 year

• Severe COVID-19 disease in pregnant women

  Through completion of the study, an average of 1 year

Interventions

COVID-19 positive via testing OTHER

Pregnant women admitted to Obstetric Units undergo RT-PCR testing for the detection of SARS-Cov2 (COVID-19 infection)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who presented to our Institution during the study period

You may qualify if:

• \>18 years-old
• Pregnant women admitted to obstetric units (Labor and Delivery, Antepartum High Risk Pregnancy, pre-operative obstetric related surgeries as Cesarean or Cerclage) of Inova Health System hospitals

You may not qualify if:

• \- Pregnant women not tested for COVID-19

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

INOVA Health System

Falls Church, Virginia, 22042, United States

Location

Related Publications (6)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• CDC. Coronavirus Disease 2019 (COVID-19) in the U.S. Centers for Disease Control and Prevention. Published April 29, 2020. Accessed May 5, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

  BACKGROUND

• CDC. Coronavirus Disease 2019 (COVID-19) - Transmission. Centers for Disease Control and Prevention. Published April 13, 2020. Accessed May 5, 2020. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html

  BACKGROUND

• Furukawa NW, Brooks JT, Sobel J. Evidence Supporting Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 While Presymptomatic or Asymptomatic. Emerg Infect Dis. 2020 Jul;26(7):e201595. doi: 10.3201/eid2607.201595. Epub 2020 Jun 21.

  PMID: 32364890 BACKGROUND

• Vintzileos WS, Muscat J, Hoffmann E, John NS, Vertichio R, Vintzileos AM, Vo D. Screening all pregnant women admitted to labor and delivery for the virus responsible for coronavirus disease 2019. Am J Obstet Gynecol. 2020 Aug;223(2):284-286. doi: 10.1016/j.ajog.2020.04.024. Epub 2020 Apr 26. No abstract available.

  PMID: 32348743 BACKGROUND

• Vahidy FS, Nicolas JC, Meeks JR, Khan O, Pan A, Jones SL, Masud F, Sostman HD, Phillips R, Andrieni JD, Kash BA, Nasir K. Racial and ethnic disparities in SARS-CoV-2 pandemic: analysis of a COVID-19 observational registry for a diverse US metropolitan population. BMJ Open. 2020 Aug 11;10(8):e039849. doi: 10.1136/bmjopen-2020-039849.

  PMID: 32784264 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: July 22, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

US (1)