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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Recruitment Status : Withdrawn (FDA/IRB approved but hospital administration vetoed the study fearing litigation of a preterm birth though the electrical uterine pacemaker/EI is not the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

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.

Condition or disease Intervention/treatment Phase
Premature Birth Premature Labor Device: Electrical Inhibition (EI) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
Actual Study Start Date : February 9, 2016
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : August 15, 2016

Arm Intervention/treatment
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.
Device: Electrical Inhibition (EI)
constant direct current 1-20mA transvaginal 10 second bursts only when needed




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569216


Locations
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United States, New York
New York University Hospital
Manhattan, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Study Director: Jeffrey Karsdon, M.D. New York University Hospital
Publications of Results:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02569216    
Other Study ID Numbers: 15-00553
G080036 ( Other Identifier: FDA )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NYU Langone Health:
Electrical Inhibition
Preterm Birth
Premature Birth
Preterm Labor
Premature Labor
tocolytic
uterus
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications