Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

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

Study Overview

• Status: Terminated
• Conditions: Fetal Distress
• Intervention / Treatment: Device: ISS Device

Detailed Description

The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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
2. Age greater than or equal to 18 years of age.
3. Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
4. Spinal or epidural anesthesia

Exclusion Criteria:

1. Emergency cesarian delivery
2. Non-reassuring fetal heart rate tracing
3. Less than 18 years of age
4. Multiple gestation (twins, triplets)
5. Presentation other than vertex or breech
6. Less than 36 weeks of gestation
7. General anesthesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Raydiant Oximetry, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: ISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No