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

NYU Langone Health

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Premature Birth Premature Labor

Interventions

Electrical Inhibition (EI)DEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New York University Hospital

Manhattan, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 seconds

Secondary Outcomes

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.

Time frame: 20 seconds

Data from ClinicalTrials.gov

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