NCT02569216

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Premature Birth
• Premature Labor

Interventions

Type	Name	Description
DEVICE	Electrical Inhibition (EI)	constant direct current 1-20mA transvaginal 10 second bursts only when needed

Timeline

• Start date: 2016-02-09
• Primary completion: 2016-08-15
• Completion: 2016-08-15
• First posted: 2015-10-06
• Last updated: 2017-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study