Risks of COVID19 in the Pregnant Population

NCT04379284 | Completed

• 1 other identifier: 20-003251
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.

Conditions

COVID19

Keywords

COVID19; Coronavirus; Pregnancy; Viral infection

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of maternal fetal transmission of COVID19

  Standardized testing of maternal, placental, and neonatal specimens will be used to determine presence of current infection with SARS-CoV2. Clinical RT-PCR assays will be used to determine the presence of viral RNA in all specimens.

  12 months

Secondary Outcomes (2)

• Describe the outcomes of COVID19 positive pregnancies

  12 months

• Understand the placental impact of COVID19 in pregnancy at various gestational ages

  12 months

Study Arms (2)

Pregnant women - positive COVID19 test

Pregnant women of any gestational age 8 weeks through delivery with a positive COVID19 test, with or without physical symptoms

Other: Biospecimen collection

Pregnant women - negative or unknown COVID19 test

Pregnant women experiencing any respiratory or other physical symptoms of COVID19 at onset of labor, with negative or uncertain COVID19 test results

Other: Biospecimen collection

Interventions

Biospecimen collection OTHER

Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating. Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

Pregnant women - negative or unknown COVID19 test; Pregnant women - positive COVID19 test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women testing positive for COVID19 at any time during their pregnancy after 8 weeks gestation, with or without physical symptoms. Pregnant women with respiratory or other physical symptoms of COVID19 and uncertain or negative COVID19 test results at the onset of labor. Infants of these women will be followed for outcomes.

You may qualify if:

• Pregnant women ages 18 - 45 years of age and their newborn infants
• Willing and able to provide written informed consent
• Planning to deliver at Mayo Clinic in Rochester, MN

You may not qualify if:

• Positive for HIV, HBV, or TB
• Delivery does not occur at Mayo Clinic

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal specimens obtained at time of enrollment prior to delivery: blood, vaginal swab, anorectal swab. Breastmilk obtained before hospital discharge and again at six weeks postpartum if the mother is lactating. Neonatal specimens: placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Virus Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Regan N Theiler, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 8, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)