CompletedEarly Phase 1

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

United States103 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC

Timeframe: Stage I and II Labor

Trial details

NCT IDNCT01400880

SponsorConvergent Engineering, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2014-09-09

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