An Electro-Inhibition (EI)/Uterine Pacemaker Device to Prevent Uterine Contractions of Preterm Birth.
Recruitment status was Recruiting
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.
Device: Electro-Inhibition (EI)/uterine pacemaker
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||A Randomized Prospective Controlled Pilot and Clinical Study to Evaluate the Electro-Inhibition (EI)/Uterine Pacemaker Device to Prevent Uterine Contractions.|
- Decreased uterine contractions
- No fetal heart arrhythmias
- Increased latency of birth
- Decreased pain during the birthing process
- Normal Apgars
- Normal newborn
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||March 2005|
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.
|Contact: Jeffrey Karsdon, M.D||516-603-6668||Jeffrey.Karsdon@downtownhospital.org|
|United States, New York|
|New York Downtown Hospital||Recruiting|
|New York, New York, United States, 10038|
|Contact: Jeffrey Karsdon, M.D. 212-312-5000 ext 5437 Jeffrey.Karsdon@downtownhospital.org|
|Principal Investigator: Jeffrey Karsdon, M.D.|
|Study Director:||Giuseppe Del Priore, M.D., M.P.H.||New York Downtown Hospital|