Early Phase 1
Completed N=103
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
Source: ClinicalTrials.gov NCT01400880 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC — 2.98; 3.95 seconds
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.
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 | — |
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
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. Informational only — not medical advice.