TerminatedNot Applicable

Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Stopped: COVID-19

United States4 participantsStarted 2019-07-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Optical signal from maternal and fetal tissues

Timeframe: Peri-operative

Trial details

NCT IDNCT04081584

SponsorRaydiant Oximetry, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05-20

View on ClinicalTrials.gov More Fetal Distress trials