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Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04081584
Recruitment Status : Suspended (COVID-19)
First Posted : September 9, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Raydiant Oximetry, Inc.

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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


Primary Outcome Measures :
  1. Optical signal from maternal and fetal tissues [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing a C-Section
Sampling Method:   Non-Probability Sample
Study Population
Women with singleton pregnancies of 36 weeks gestation or more undergoing c-section.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081584


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Raydiant Oximetry, Inc.
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Responsible Party: Raydiant Oximetry, Inc.
ClinicalTrials.gov Identifier: NCT04081584    
Other Study ID Numbers: ISS
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fetal Distress