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

Primary Purpose

Premature Birth, Premature Labor

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electrical Inhibition (EI)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Electrical Inhibition, Preterm Birth, Premature Birth, Preterm Labor, Premature Labor, tocolytic, uterus

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • New York University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Inhibition (EI) intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Decrease tocodynamometric monitored preterm uterine contraction frequency
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

Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity.
Measure changes in preterm uterine electrical contraction activity as assessed by the electrohysterogram. This will be done for the duration of the study.

Full Information

First Posted
October 1, 2015
Last Updated
November 7, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02569216
Brief Title
Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth
Acronym
EI
Official Title
Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
August 15, 2016 (Actual)
Study Completion Date
August 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Premature Labor
Keywords
Electrical Inhibition, Preterm Birth, Premature Birth, Preterm Labor, Premature Labor, tocolytic, uterus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical Inhibition (EI) intervention
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Electrical Inhibition (EI)
Intervention Description
constant direct current 1-20mA transvaginal 10 second bursts only when needed
Primary Outcome Measure Information:
Title
Decrease tocodynamometric monitored preterm uterine contraction frequency
Description
Measure changes in preterm uterine mechanical contraction frequency as assessed by the tocodynamometer. This will be done for the duration of the study.
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity.
Description
Measure changes in preterm uterine electrical contraction activity as assessed by the electrohysterogram. This will be done for the duration of the study.
Time Frame
20 seconds

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Karsdon, M.D.
Organizational Affiliation
New York University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
New York University Hospital
City
Manhattan
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16325601
Citation
Karsdon J, Garfield RE, Shi SQ, Maner W, Saade G. Electrical inhibition of preterm birth: inhibition of uterine contractility in the rabbit and pup births in the rat. Am J Obstet Gynecol. 2005 Dec;193(6):1986-93. doi: 10.1016/j.ajog.2005.05.009. Erratum In: Am J Obstet Gynecol. 2006 Feb;194(2):595.
Results Reference
result
PubMed Identifier
23089601
Citation
Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.
Results Reference
result

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

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