Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes

Summary

Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses.

The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project.

The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.

Conditions

• Congenital Heart Disease
• Viremia
• Virus Diseases
• Enterovirus
• Enterovirus Infections
• Heart Defects, Congenital
• Heart Diseases
• Prenatal Infection
• Diabetes
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type 1
• Diabetes Mellitus
• Pregnancy in Diabetic
• Pregnancy Complications
• Prenatal

Interventions

OTHER

Stool and Blood Specimen Collection

Stool and Blood specimens will be collected at 3 designated time points

OTHER

Follow-up Medical Record Review

Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Pirooz Eghtesady, MD, PhD · Faculty

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2023-12-05

Completion

2023-12-05

Countries

• United States

Study Locations