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

Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth

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.

Study Overview

• Status: Withdrawn
• Conditions: Premature Birth; Premature Labor
• Intervention / Treatment: Device: Electrical Inhibition (EI)

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: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhattan, New York, United States, 10016
      • New York University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 seconds

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Study Director: Jeffrey Karsdon, M.D., New York University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2016
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Premature Birth; Preterm Birth; uterus; tocolytic; Preterm Labor; Premature Labor; Electrical Inhibition
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 15-00553; G080036 (Other Identifier: FDA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes