Early Phase 1 N=103 Device Feasibility

Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT01400880 ↗

Enrolled (actual)

103

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC — 2.98; 3.95 seconds

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Electrode-based Sensor (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Convergent Engineering, Inc.
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC	2.98; 3.95	—

Summary

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

Eligibility Criteria

Inclusion Criteria

Women between the ages of 18 and 50 years old
>/= 34 weeks gestation
Single viable fetus in cephalic presentation

Exclusion Criteria

Bleeding or uterine scarring

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01400880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.