Pilot Study of Electronic Uterine Contraction Inhibitor
Summary
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 weak electrical current provided by an electrical inhibition/uterine pacemaker device.
Preterm birth is still a major problem. Current methods of preventing the uterine contractions of preterm are limited and associated with many side-effects affecting both the mother and baby. A reliable method of preventing preterm uterine contractions would be an important discovery. Such a method could eventually lead to a long-term goal of decreasing neonatal morbidity and mortality.
Description
The study design is a Pilot Study to confirm the safety of the uterine inhibitor/pacemaker and measure its effect on women experiencing preterm labor.
A total of 10 (ten) patients will be enrolled in this pilot study to confirm the methodology and safety of the device. Patients who meet the inclusion criteria and none of the exclusion criteria will be recruited for the study.
The study device (EI/uterine inhibitor/pacemaker) has been classified by FDA as an Investigational Device Exemption (IDE) number G080036, Class A device. The EI/uterine inhibitor/pacemaker device is FDA cleared for research of the prevention of the prevention of the human contractions of preterm birth.
This proposal is for an initial prospective FDA approved pilot study. After FDA evaluation of the pilot study findings and approval, the pilot study may lead eventually to a prospective randomized controlled clinical study.
Only adult women who are experiencing uterine contractions due to the birthing process are eligible.
Study patients will be informed about the purpose of the EI/uterine inhibitor/pacemaker device and give informed consent prior to its use. The device will be used for only 20 minutes, preceded and followed by a 20 minute control period.
During the birthing process recordings of the uterine contractions will be recorded. Comparison will be made of these uterine contraction records pre and post use use of the EI/uterine inhibitor/pacemaker device. The uterine contraction tracings will be compared and analyzed for differences in the frequency of contractions.
The patients will also be told how to express the strength of any of their subjective pain in a manner that can be documented in a questionnaire. Study patients will also have their record of the type and amount of pain medication they have received noted on their patient log forms.
RISK:
Previous human and animal studies indicate minimal risk to either baby or mother. Human studies showed no effect on the fetal or maternal heart rate. Real-time monitoring of the fetal and maternal heart rate during the study will protect against there potential risks.
BENEFIT:
Reducing the frequency of preterm uterine contractions is a first step to preventing preterm birth,but the proposed investigation is not, itself, expected to prevent any preterm births. However, the investigation could have great benefit to future mothers and their babies.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Conditions
Prematurity
Intervention
Electrical Inhibition (EI) Uterine Pacemaker
Location
Winthrop University Hospital
Mineola
New York
United States
11501
Status
Recruiting
Source
Winthrop University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00994058
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cardiotocography
Monitoring of fetal heart frequency before birth in order to assess impending prematurity in relation to the pattern or intensity of antepartum UTERINE CONTRACTION.
Uterine Balloon Tamponade
Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.
Uterine Monitoring
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.
Uterine Cervical Neoplasms
Tumors or cancer of the UTERINE CERVIX.
Uterine Cervical Diseases
Pathological processes of the UTERINE CERVIX.
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