TerminatedNot Applicable

Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

Stopped: Device was unacceptable to patients and did not provide expected outputs

United States10 participantsStarted 2015-12

Plain-language summary

This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.

Who can participate

SexFEMALE

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Exclusion criteria

✕. Women with multiple gestations.
✕. Women with contraindications to pushing during second stage labor.
✕. Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.
✕. Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).

What they're measuring

Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output

Timeframe: Second stage of labor begins once the patient's cervix is completely dilated and ends once the baby is delivered. This time will be compared between patients.

Trial details

NCT IDNCT02648867

SponsorClinical Innovations, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Prolonged Second Stage of Labor trials