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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


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
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