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

Premature Birth Clinical Trial

— EI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02569216
• Other study ID #: 15-00553
• Secondary ID: G080036
• Status: Withdrawn
• Phase: Phase 1
• First received: October 1, 2015
• Last updated: November 7, 2017
• Start date: February 9, 2016
• Est. completion date: August 15, 2016

Study information

• Verified date: November 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Premature Labor

Intervention

Device:
• Electrical Inhibition (EI)
constant direct current 1-20mA transvaginal 10 second bursts only when needed

Locations

Country	Name	City	State
United States	New York University Hospital	Manhattan	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136. — View Citation

Karsdon J, Garfield RE, Shi SQ, Maner W, Saade G. Electrical inhibition of preterm birth: inhibition of uterine contractility in the rabbit and pup births in the rat. Am J Obstet Gynecol. 2005 Dec;193(6):1986-93. Erratum in: Am J Obstet Gynecol. 2006 Feb; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 seconds
Secondary	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.	20 seconds