Health TrialsbyHealthPanel

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

ConditionsFetal HypoxiaFetal Acidemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRaydiant Oximetry, Inc.

About this trial

The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing and capable of providing informed consent.

Age > 18 years.

Gestational age > 36 weeks.

Singleton pregnancy.

Disqualifiers

Age < 18 years.

Gestational age < 36 weeks

Multiple gestation

Nonvertex fetal presentation

Trial design

Design model

Single group

Treatments tested in this trial

  • Fetal Pulse Oximetery

    Device

    Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Dual Sensor RecipientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of device-related adverse events

Rate of device-related adverse events such as erythema or rash

Time frame
Periprocedural

Secondary outcomes

1

Maternal Outcomes

Maternal adverse outcomes such as chorioamnionitis or endometritis

Time frame
Periprocedural
2

Neonatal Outcomes

Apgar Scores at 1 and 5 minutes

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Raydiant Oximetry, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now