CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Electrical Intervention (EI)device
Likely dose
Electrical intervention: bipolar, constant-current pulses (1-20 mA), square-wave in 20% duty cycles; applied vaginally in successive 20-minute periodsAI-extracted
Key inclusion· 2
  • ✓Pending preterm birth
  • ✓Planned vaginal birth
Key exclusion· 3
  • ✕Systemic disease disorders including thyroid disease, liver disease, HIV, diabetes, or drug addiction
  • ✕Using a permanent cardiac pacemaker
  • ✕Active or recurrent malignancy currently being treated

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00212446
NCT00212446N/ACompleted
CompareCT.gov

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

St. Luke's-Roosevelt Hospital Center·interventional·Posted Sep 21, 2005·Updated Dec 17, 2018

In Brief

A clinical study evaluating Electrical Intervention (EI) for Preterm Birth. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartFeb 1, 2005
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.8 years ago

Interventions

Electrical Intervention (EI)device

Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).