Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04081584
Other study ID # ISS
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date June 8, 2021

Study information

Verified date August 2021
Source Raydiant Oximetry, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date June 8, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Raydiant Oximetry, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Peri-operative
See also
  Status Clinical Trial Phase
Completed NCT02221440 - Maternal Oxygen Administration for Fetal Distress N/A
Completed NCT04325243 - Sildenafil Citrate and Intrapartum Fetal Distress Phase 4
Completed NCT03095937 - Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients
Completed NCT00185887 - Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation N/A
Completed NCT02862925 - Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings. N/A
Recruiting NCT06186973 - Fetal Assessment of the Myocardium and Evaluation of the Neonate
Recruiting NCT05681624 - Maternal Oxygen Supplementation for Intrauterine Resuscitation N/A
Completed NCT05946681 - Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Completed NCT03536910 - Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique N/A
Completed NCT03156608 - Novii External Fetal Monitoring Device N/A
Recruiting NCT00246766 - Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy N/A
Recruiting NCT04043299 - Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes Phase 3
Not yet recruiting NCT03859037 - Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation N/A
Completed NCT03370822 - A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
Terminated NCT05147584 - Trans-abdominal Fetal Pulse Oximetry N/A
Not yet recruiting NCT05727241 - Three-dimensional Umbilical Cord Coiling Index
Completed NCT03764696 - Maternal Oxygen Administration for Fetal Distress II N/A
Completed NCT01042262 - Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase N/A
Not yet recruiting NCT04548453 - Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions Early Phase 1
Completed NCT03159234 - Prediction of Fetal Lung Maturity N/A