Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

NCT04081584 | Terminated FDA Device

• 1 other identifier: ISS
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to study light scattering properties of maternal-fetal tissue.

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

• Optical signal from maternal and fetal tissues

  The study of light scattering through maternal/fetal tissue and through maternal tissue alone and newborn tissue alone using a commercial frequency domain oximeter and 2nd generation prototype.

  Peri-operative

Interventions

ISS Device DEVICE

The ISS Device (commercial and prototype) is used to measure tissue light scattering.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing a C-Section
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with singleton pregnancies of 36 weeks gestation or more undergoing c-section.

You may qualify if:

• Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing
• Age greater than or equal to 18 years of age.
• Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
• Spinal or epidural anesthesia

You may not qualify if:

• Emergency cesarian delivery
• Non-reassuring fetal heart rate tracing
• Less than 18 years of age
• Multiple gestation (twins, triplets)
• Presentation other than vertex or breech
• Less than 36 weeks of gestation
• General anesthesia

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 9, 2019
• Study Start: July 1, 2019
• Primary Completion: May 20, 2021
• Study Completion: June 8, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)