N/A
N=71
Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability
Laboring Women With Ultrasound and FSE Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT02024165 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Fetal Heart Rate Interpretability — 83.4; 62.4 percentage of time the signals are inter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- OBMedical Company
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate Interpretability |
83.4; 62.4 | — |
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
- Parturients presenting to Labor & Delivery for labor at term (>36 weeks completed gestation)
- Single viable fetus in cephalic presentation
- With FSE or IUPC for obstetric indications
Exclusion Criteria
- Multi fetal gestation
- Contraindication to FSE or IUPC placement
- Insufficient abdominal space for all required sensors
Data sourced from ClinicalTrials.gov (NCT02024165). 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.