Status:
COMPLETED
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Conditions:
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 un...
Detailed Description
The preterm birth rate in the United states has been stubbornly stuck at 10.5% or higher since the 1950's. The 2011 rate, 11.72%, is the most recent level available. That comes to about a half a milli...
Eligibility Criteria
Inclusion
- Pending preterm birth
- vaginal birth
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00212446
Start Date
February 1 2005
End Date
April 1 2012
Last Update
December 17 2018
Active Locations (1)
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1
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019