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

Withdrawn before enrolling · Phase 1

Conditions studied: Premature Birth, Premature Labor

In brief

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.

Key facts

Study ID

NCT02569216

Run by

NYU Langone Health

People needed

0

Starts

2016-02-09

Expected to finish

2016-08-15

Last updated by the study team

2017-11-09

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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