Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth (EI)
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|ClinicalTrials.gov Identifier: NCT02569216|
Recruitment Status : Withdrawn (FDA/IRB approved but hospital administration vetoed the study fearing litigation of a preterm birth though the electrical uterine pacemaker/EI is not the cause.)
First Posted : October 6, 2015
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth Premature Labor||Device: Electrical Inhibition (EI)||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth|
|Actual Study Start Date :||February 9, 2016|
|Actual Primary Completion Date :||August 15, 2016|
|Actual Study Completion Date :||August 15, 2016|
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
- Decrease tocodynamometric monitored preterm uterine contraction frequency [ Time Frame: 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.
- Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569216
|United States, New York|
|New York University Hospital|
|Manhattan, New York, United States, 10016|
|Study Director:||Jeffrey Karsdon, M.D.||New York University Hospital|