Trial Outcomes & Findings for Trans-abdominal Fetal Pulse Oximetry (NCT NCT05147584)

NCT ID: NCT05147584

Last Updated: 2025-02-04

Results Overview

Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.

Recruitment status

TERMINATED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

During labor

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Interventional/Observational The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively. Dual fetal oxygen sensors: Placement of both internal and external fetal oxygen sensors
Overall Study STARTED	31
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Interventional/Observational The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively. Dual fetal oxygen sensors: Placement of both internal and external fetal oxygen sensors
Overall Study Subjects consented but did not fully meet inclusion /exclusion criteria	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional/Observational n=23 Participants The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively. Dual fetal oxygen sensors: Placement of both internal and external fetal oxygen sensors
Age, Continuous Age	27.4 years n=23 Participants
Sex: Female, Male Female	23 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=23 Participants
Region of Enrollment United States	23 participants n=23 Participants
Skin color according to Fitzpatrick Scales Type I Skin Color	2 Participants n=23 Participants
Skin color according to Fitzpatrick Scales Type II Skin Color	6 Participants n=23 Participants
Skin color according to Fitzpatrick Scales Type III Skin Color	12 Participants n=23 Participants
Skin color according to Fitzpatrick Scales Type IV Skin Color	2 Participants n=23 Participants
Skin color according to Fitzpatrick Scales Type V Skin Color	0 Participants n=23 Participants
Skin color according to Fitzpatrick Scales Type VI Skin Color	1 Participants n=23 Participants

PRIMARY outcome

Timeframe: During labor

Population: All 23 subject files were analyzed. Of the 23 participants who completed the monitoring period, 15 were considered to have adequate paired data for analysis of fetal signal.

Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.

Outcome measures

Outcome measures
Measure	Interventional/Observational n=23 Participants The internal and external oxygen sensors will be used to record fetal oxygen during active labor. Dual fetal oxygen sensors were used: Placement of both internal and external fetal oxygen sensors to record fetal signals.
Fetal Oxygen Levels	15 Participants

PRIMARY outcome

Timeframe: During labor

Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum. Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.

Outcome measures

Outcome measures
Measure	Interventional/Observational n=23 Participants The internal and external oxygen sensors will be used to record fetal oxygen during active labor. Dual fetal oxygen sensors were used: Placement of both internal and external fetal oxygen sensors to record fetal signals.
Adverse Events	0 participants

Adverse Events

Interventional/Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Kemp

Raydiant Oximetry, Inc.

Phone: 4083751465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place