Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

NCT ID: NCT04081584

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-06-08

Brief Summary

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

Detailed Description

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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

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Fetal Distress

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ISS Device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Raydiant Oximetry, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ISS

Identifier Type: -

Identifier Source: org_study_id

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