CompletedNot Applicable

Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

United States8 participantsStarted 2005-02

Plain-language summary

Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine contractions of preterm birth.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Pending preterm birth * vaginal birth Exclusion Criteria: * disease disorders including but not limited to thyroid, liver disease, HIV, diabetes or drug addiction * using a permanent cardiac pacemaker * have malignancies that are currently being treated or recurrent

What they're measuring

Uterine Contractions

Timeframe: 20 minutes, 40 minutes, 60 minutes

Number of Newborn With Fetal Heart Arrhythmias

Timeframe: 60 minutes

Trial details

NCT IDNCT00212446

SponsorSt. Luke's-Roosevelt Hospital Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-04

Results submitted2018-02-20

View on ClinicalTrials.gov More Preterm Birth trials