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

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Recruitment Status : Withdrawn (FDA/IRB approved but hospital administration vetoed the study fearing litigation of a preterm birth though the electrical uterine pacemaker/EI is not the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

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

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

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

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