Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

October 17, 2025

Study Completion Date

October 17, 2025

Conditions
Fetal HypoxiaFetal DistressFetal ConditionsFetal ComplicationsLabor Fetal AnoxiaLabor (Obstetrics)--ComplicationsOxygen Deficiency
Interventions
DEVICE

Fetal Oxygenation Measurements

The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.

Trial Locations (1)

23510

Sentara Norfolk General - Eastern Virginia Medical School, Norfolk

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Raydiant Oximetry, Inc.

INDUSTRY

NCT06405984 - Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE | Biotech Hunter | Biotech Hunter