Pilot Study of Electronic Uterine Contraction Inhibitor
NCT ID: NCT00994058
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-10-31
2010-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intevention with Inhibitor
Electrical Inhibition (EI) Uterine Pacemaker
An external powered pulse generator, pacemaker for external stimulation of the uterine muscle through the vaginal canal for the therapeutic use of preventing preterm birth.
Patients with preterm contractions (\< 37 weeks gestation) will be monitored for contraction frequency for 20 minutes before, 20 minutes during use of EI and 20 minutes after EI/uterine inhibitor/pacemaker. Device generates a weak electrical current (0-10mA, 0-50 Hz, 0-50mS).
Interventions
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Electrical Inhibition (EI) Uterine Pacemaker
An external powered pulse generator, pacemaker for external stimulation of the uterine muscle through the vaginal canal for the therapeutic use of preventing preterm birth.
Patients with preterm contractions (\< 37 weeks gestation) will be monitored for contraction frequency for 20 minutes before, 20 minutes during use of EI and 20 minutes after EI/uterine inhibitor/pacemaker. Device generates a weak electrical current (0-10mA, 0-50 Hz, 0-50mS).
Eligibility Criteria
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Inclusion Criteria
2. preterm labor
* at least one contraction every 5 minutes for 30 minutes
* \> 3 cm cervical dilation; \> 80% cervical effacement
3. Have received tocolysis therapy
4. Anticipate a normal spontaneous vaginal delivery (NSVD)
5. Be at least 18 years of age
6. Have signed a written informed consent document
7. Be willing and able to comply with study requirements
Exclusion Criteria
2. Severe abruption placenta
3. Rupture of amnionic membranes
4. Frank chorioamnionitis
5. Fetal death
6. Fetal anomaly incompatible with life
7. Severe fetal growth restriction (estimated fetal weight \<5%)
8. Mature fetal lung studies
9. Maternal cardiac arrythmias
10. A permanent cardiac pacemaker
11. A fetal cardiac arrhythmia
18 Years
50 Years
FEMALE
No
Sponsors
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Winthrop University Hospital
OTHER
Responsible Party
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Dept OB/GYN, Winthrop University Hospital
Principal Investigators
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Graham G Ashmead, MD
Role: PRINCIPAL_INVESTIGATOR
Winthrop University Hospital
Locations
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Winthrop University Hospital
Mineola, New York, United States
Countries
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References
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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.
Other Identifiers
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09034
Identifier Type: -
Identifier Source: org_study_id