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Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth (EI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569216
Recruitment Status : Withdrawn (FDA/IRB approved but hospital administration vetoed the study fearing litigation of a preterm birth though the electrical uterine pacemaker/EI is not the cause.)
First Posted : October 6, 2015
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date November 9, 2017
Actual Study Start Date  ICMJE February 9, 2016
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Decrease tocodynamometric monitored preterm uterine contraction frequency [ Time Frame: 30 seconds ]
Measure changes in preterm uterine mechanical contraction frequency as assessed by the tocodynamometer. This will be done for the duration of the study.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity. [ Time Frame: 20 seconds ]
Measure changes in preterm uterine electrical contraction activity as assessed by the electrohysterogram. This will be done for the duration of the study.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth
Official Title  ICMJE Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
Brief Summary An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.
Detailed Description

Electrical intervention (EI) uses bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in active preterm labor have an electrode catheter placed into the posterior fornix of the vaginal canal. The EI current is given up to 80 minutes while monitoring tocodynamometric (toco) contractions and adjunct electrohysterographic (EHG) activity while continuously monitoring maternal vital signs, fetal heart rate and electrocardiogram (fECG). The study includes a pre-EI control period (C1); the EI period, when a 10-second current burst is delivered only during a contraction; and a post-EI control period (C2). The whole study will take a maximum of two hours.

The uterine toco contraction frequency and adjunct EHG electrical activity are analyzed for changes caused by EI. Changes in maternal vital signs, fetal heart rate and fECG will determine EI side-effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Premature Birth
  • Premature Labor
Intervention  ICMJE Device: Electrical Inhibition (EI)
constant direct current 1-20mA transvaginal 10 second bursts only when needed
Study Arms  ICMJE Experimental: Electrical Inhibition (EI) intervention
Electrical Inhibition (EI) uterine pacemaker is activated only when there is a preterm uterine contraction. The EI uterine pacemaker delivers a 1-15mA (20mA maximum) constant direct current for only 2 seconds only while there is a preterm uterine contraction.
Intervention: Device: Electrical Inhibition (EI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 11, 2016)
0
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 15, 2016
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • between 24 to 34 weeks pregnant with a singleton gestation;
  • in preterm labor as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics,78 as follows:

    • persistent uterine contractions (4 every 20 minutes or 8 every 60 minutes)
    • And any one or more of the following:

      • Documented cervical change
      • > 1cm cervical dilatation and progressing
      • > 80% cervical effacement
  • anticipate a normal spontaneous vaginal delivery (NSVD).
  • at least 18 years of age
  • signed a written Informed Consent Document
  • willing and able to comply with study requirements

Exclusion Criteria:

  • severe preeclampsia
  • severe abruption placenta
  • rupture of amniotic membranes
  • frank chorioamnionitis
  • fetal death
  • fetal anomaly incompatible with life
  • severe fetal growth restriction (EFW <5%)
  • mature fetal lung studies
  • maternal cardiac arrhythmias
  • a permanent cardiac pacemaker
  • a fetal cardiac arrhythmia
  • contraindication for tocolysis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569216
Other Study ID Numbers  ICMJE 15-00553
G080036 ( Other Identifier: FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeffrey Karsdon, M.D. New York University Hospital
PRS Account NYU Langone Health
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP