An Electro-Inhibition (EI)/Uterine Pacemaker Device to Prevent Uterine Contractions of Preterm Birth.

2014-08-27 03:49:15 | BioPortfolio


Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine contractions of preterm birth.


The prevalence of preterm birth is rising steadily over the past two decades, from about 9% in 1981 to 12% in 2002 in spite of mostly pharmaceutical methods of prevention. That comes to about a half a million preterm births per year in the United States alone.

Premature birth and the attendant complications are among the greatest health problem in the world today and contribute to about 85% of all neonatal deaths i.e. from birth to 1 month old.

During the past five years, there has been developed a novel method to effectively and objectively inhibit uterine contractility during the birthing process.

The method is nonpharmaceutical. Thus with no systemic side effects and with the potential of being noninvasive, easy to master, rapid onset with rapid reversal.

This method uses an Electrical Inhibition (EI)/uterine pacemaker device that will allow for rapid and reversible inhibition of preterm uterine contractions and preterm birth.

The following is a brief account of the electrical properties of the myometrium and why these properties may be affected by electrical inhibition (EI).

The contractile activity of the uterus is a direct consequence of the underlying electrical activity in the myometrial cells. The sequence of contraction and relaxation of the myometrium results from the cyclic depolarization and repolarization of the membranes of the muscle cells.

The uterus at term has been shown to be myogenic just like the heart. The uterus will contract spontaneously without neuronal control, like the heart, and form gap junctions interconnecting the cells just like the syncytium of the heart. Also, both are excitable tissues with similar current flows.

Electrical Inhibition (EI) has successfully inhibited myometrial or uterine contractions in many different species e.g. sheep, rabbit, rat, and human (in vitro). The EI was effective in live animals when used on the uterus either directly attached or transvaginally.

This study is a randomized prospective single-center controlled clinical study, in which a total of 24 evaluable patients will be enrolled into two separate groups: a Study Group, with 12 patients using the active EI/uterine pacemaker device; and Control Group (Placebo-Control) with 12 patients using a non-electrically active device. All women experiencing the birthing process between a minimum of 27 weeks and a maximum of 36 weeks gestation will be offered enrollment into the study.

This electrical inhibition will be given intermittently for only several minutes while the standard tocolytic therapy is being prepared.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention


Preterm Birth


Electro-Inhibition (EI)/uterine pacemaker


New York Downtown Hospital
New York
New York
United States




New York Downtown Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:49:15-0400

Clinical Trials [2171 Associated Clinical Trials listed on BioPortfolio]

Pilot Study of Electronic Uterine Contraction Inhibitor

The objective is to test a novel paradigm for the inhibition of human preterm uterine contractions. The study hypothesis is that human preterm contractions can be safely inhibited with a ...

Electrical Inhibition of Human Preterm Contractions

The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approve...

Time to Delivery of Preterm Birth

Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby. When mothers are identified ...

Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the deve...

The Use of Progesterone to Reduce Preterm Birth

Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have...

PubMed Articles [7284 Associated PubMed Articles listed on BioPortfolio]

The predictive capacity of uterine artery Doppler for preterm birth - a cohort study.

Mid-trimester uterine artery resistance measured with Doppler sonography is predictive for iatrogenic preterm birth. In view of the emerging association between hypertensive disease in pregnancy and s...

Preterm birth and the future risk of orthopedic fracture.

Preterm birth occurs during a critical period of bone mineralization. We assessed whether preterm birth increases the risk of childhood fracture.

Comparison of the myometrial transcriptome from singleton and twin pregnancies by RNA-Seq.

Preterm birth is recognized as the primary cause of infant mortality worldwide. Twin pregnancies are significantly more at risk of preterm birth than singleton pregnancies. A greater understanding of ...

Cervico-vaginal placental alpha-microglobulin-1 (PAMG-1) combined with cervical length for the prediction of preterm birth in women with threatened preterm labor.

Preterm birth is a major cause of neonatal morbidity and mortality. There is an urgent need to accurately predict imminent delivery to enable necessary interventions such as tocolytic, glucocorticoid ...

Procoagulant imbalance in preterm neonates detected by thrombin generation procedures.

Preterm newborns are considered at risk of acquired coagulopathy and are often prophylactically infused with fresh frozen plasma (FFP) even in the absence of bleeding. To assess the coagulation asset ...

Medical and Biotech [MESH] Definitions

Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Monitoring of fetal heart frequency before birth in order to assess impending prematurity in relation to the pattern or intensity of antepartum UTERINE CONTRACTION.

Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.

More From BioPortfolio on "An Electro-Inhibition (EI)/Uterine Pacemaker Device to Prevent Uterine Contractions of Preterm Birth."

Quick Search

Relevant Topics

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial