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

Phase 1

Withdrawn

• Conditions: Premature Labor; Premature Birth
• Interventions: Device: Electrical Inhibition (EI)

• Registration Number: NCT02569216
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Study Start: 2016-02-09
• Primary Completion: 2016-08-15
• Study Completion: 2016-08-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical Inhibition (EI) intervention	Electrical Inhibition (EI)	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.

Primary Outcome Measures

Name	Time	Method
Decrease tocodynamometric monitored preterm uterine contraction frequency	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

Name	Time	Method
Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity.	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.

Trial Locations

Locations (1)

New York University Hospital; 🇺🇸 Manhattan, New York, United States