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Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

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: NCT04081623
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 project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,

Condition or disease Intervention/treatment
Fetal Distress Device: Raydiant Oximetry Sensing System

Detailed Description:
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
Clinic
This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)
Device: Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Other Name: ROSS

Labor and Delivery
This group is in active labor.
Device: Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Other Name: ROSS




Primary Outcome Measures :
  1. Fetal signal integrity [ Time Frame: During NST, BPP, or active labor ]
    Integrity of the fetal signal relative to background maternal signal and biologic/electronic noise, and related to fetal position, presentation and the depth of the fetus from maternal skin.



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:   Pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor
Criteria

Inclusion Criteria:

  1. Pregnant women with singleton pregnancies, vertex presentation
  2. Age ≥ 18 years
  3. Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
  4. Healthy women ≥ 37 weeks in labor
  5. Vertex presentation

Exclusion Criteria:

  1. Age <18 years
  2. Multiple gestation ( twins, triplets)
  3. Presentation other than vertex
  4. < 28 weeks of gestation

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): NCT04081623


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: NCT04081623    
Other Study ID Numbers: ROSS Gen 2
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