Clinical trial NCT02569216: Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth
Official title: Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Premature Birth
Premature Labor
Keywords: Electrical Inhibition
Preterm Birth
Premature Birth
Preterm Labor
Premature Labor
tocolytic
uterus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease tocodynamometric monitored preterm uterine contraction frequency
timeFrame: 30 seconds
Secondary outcomes:
measure: Decrease adjunct electrohysterographic monitored preterm uterine contraction electrical activity.
timeFrame: 20 seconds
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: New York University Hospital
state: New York
Study officials:
affiliation: New York University Hospital
name: Jeffrey Karsdon, M.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.ajog.2005.05.009.
citation: 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.