NCT02569216

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 9, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

October 1, 2015

Last Update Submit

November 7, 2017

Conditions

Premature BirthPremature Labor

Keywords

Electrical InhibitionPreterm BirthPremature BirthPreterm LaborPremature Labortocolyticuterus

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 seconds

Secondary Outcomes (1)

  • Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity.

    20 seconds

Study Arms (1)

Electrical Inhibition (EI) intervention

EXPERIMENTAL

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)

Interventions

Electrical Inhibition (EI)DEVICE

constant direct current 1-20mA transvaginal 10 second bursts only when needed

Electrical Inhibition (EI) intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Hospital

Manhattan, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 16325601RESULT

  • 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.

    PMID: 23089601RESULT

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jeffrey Karsdon, M.D.

    New York University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 6, 2015

Study Start

February 9, 2016

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

US(1)