Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

• Sponsor: Raydiant Oximetry, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04081584
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Actual Duration (Months): 23.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fetal Distress	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 Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: May 20, 2021
• Actual Study Completion Date: Jun 8, 2021

Outcome Measures

Primary Outcome Measures

1. Optical signal from maternal and fetal tissues [Peri-operative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Raydiant Oximetry, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raydiant Oximetry, Inc.
• ClinicalTrials.gov Identifier: NCT04081584
• Other Study ID Numbers: ISS
• First Posted: Sep 9, 2019
• Last Update Posted: Aug 11, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Fetal Distress

Study Results

No Results Posted as of Aug 11, 2021