Fetal DistressNCT04081584
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
An observational study of Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
Trial summary
This study is being conducted to study light scattering properties of maternal-fetal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Distress
- What is being tested?
- ISS Device
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 8 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women with singleton pregnancies of 36 weeks gestation or more undergoing c-section.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to study light scattering properties of maternal-fetal tissue.
Read the 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.
- Conditions
- Fetal Distress
- Being tested
- ISS Device
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISS DeviceDevice
The ISS Device (commercial and prototype) is used to measure tissue light scattering.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Jul 2019
- Primary completion20 May 2021
- Study completion8 Jun 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raydiant Oximetry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081584
- Sponsor's protocol ID
- ISS
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
- ClinicalTrials.gov ID
- NCT04081584
- Acronym / sponsor ID
- ISS
- Conditions
- Fetal Distress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Raydiant Oximetry, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to study light scattering properties of maternal-fetal tissue.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with singleton pregnancies of 36 weeks gestation or more undergoing c-section.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISS DeviceThe ISS Device (commercial and prototype) is used to measure tissue light scattering. | Device | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical signal from maternal and fetal tissues (time frame: Peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.