NCT04769167View on ClinicalTrials.gov

Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

February 20, 2025

Study Completion Date

December 31, 2027

Conditions
Congenital Heart DiseaseViremiaVirus DiseasesEnterovirusEnterovirus InfectionsHeart Defects, CongenitalHeart DiseasesPrenatal InfectionDiabetesDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1Diabetes MellitusPregnancy in DiabeticPregnancy ComplicationsPrenatal
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.

Trial Locations (2)

63110

Barnes Jewish Hospital, St Louis

St Louis Childrens Hospital, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER